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Oral Evidence

Taken before the Science and Technology Committee

on Wednesday 13 June 2012

Members present:

Andrew Miller (Chair)

Gareth Johnson

Stephen Metcalfe

Stephen Mosley

Pamela Nash

Sarah Newton

Graham Stringer

Roger Williams

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Examination of Witnesses

Witnesses: John Howlett, Head of Notified Body, British Standards Institute (Healthcare) (BSI), Peter Ellingworth, Chief Executive, Association of British Healthcare Industries (ABHI), and Mike Kreuzer, Technical and Regulatory Executive Director (ABHI), gave evidence.

Q38 Chair: Gentlemen, I welcome you to this morning’s hearing. For the record, I would be grateful if the three of you would formally introduce yourselves.

John Howlett: I am John Howlett from BSI, a UK-notified body.

Peter Ellingworth: I am Peter Ellingworth, chief executive of the Association of British Healthcare Industries. We represent the medical technology industry.

Mike Kreuzer: I am Mike Kreuzer, the director in charge of regulatory affairs for ABHI.

Q39 Chair: Perhaps I may start with you, Mr Ellingworth. Tell us a little about whom you represent in the field of implants and why it appears that none of the businesses was prepared to come and give evidence this morning.

Peter Ellingworth: We represent the medical technology industry in its broadest sense. That is everything from simple syringes and dressings all the way through to active implantable devices. The industry itself employs about 64,000 people; it is comprised of many small and medium-size enterprises in the UK. We probably represent about 75% of that industry, and we have in the order of 250 members. We operate with a mandatory code of practice for our membership as well. Our job is to represent that industry and to provide a broad industry perspective on major issues. Essentially, our role is to ensure that we create a positive environment for the uptake and diffusion of technologies that are safe and effective for patients.

Q40 Chair: And the second part of my question?

Peter Ellingworth: Indeed. As far as we were concerned, it was our role to represent the industry, and the decision by companies is entirely up to them. We do not have any particular authority over those companies.

Q41 Chair: You are not particularly surprised that none of them wanted to be here and explain to us how good their products are?

Peter Ellingworth: Indeed. We are more than happy to be here and to do that representation for them, but there are no particular issues from our perspective. Often they would expect us to take that role, and certainly we will speak openly and frankly about any issues you wish to raise.

Q42 Stephen Metcalfe: Did any of the companies who had been approached ask you to represent them here?

Peter Ellingworth: No one has particularly asked us to represent them. We get involved with the Department of Health, BIS and many other Government Departments. It is normal business for us to represent those who are our members rather than any individual company. We will not talk for an individual company. If you ask me a particular question about a company, I would not answer that simply from an equity perspective, but, broadly, I am very happy to discuss anything that you wish today.

Q43 Chair: I want to move on to you, Mr Howlett, and ask some questions about equivalence data. If the other panel members have comments they want to make, please feel free. Are you content to rely on equivalence data when certifying new implants?

John Howlett: Our role as a notified body is to ensure that the manufacturer meets the essential requirements for clinical data established in Annex X of the directive, supported by guidance in MEDDEVs, and the clinical data are established through literature or literature and a clinical investigation. If the manufacturer goes down the "literature" route, which is essentially the equivalence route, the guidance is well established, and as a notified body we follow that guidance. We do not make the rules; we implement them. The system is different from the one in the FDA with their equivalence. We do not work with the term "equivalence". The data have to be sufficient in literature or literature and trial form to meet the essential requirements of the directive.

Q44 Chair: Is that because there are difficulties in conducting clinical trials in some cases?

John Howlett: The decision on a trial has to be made in the first instance by the manufacturer. Trials are by nature costly for the manufacturer to set up, but we challenge the manufacturer on the availability of the data. In the FDA, the equivalence aspect is based on a predicate device; our measures are really against the essential requirements of the directive.

Q45 Chair: If I were a customer for an implant, I would want to know what data were being relied on to give me some confidence in the product that was going to be put inside me. Would it be better if that information was available to the patient and the doctors?

John Howlett: I think transparency of the data to support compliance would be beneficial. That is a role for the regulators. The notified bodies cannot make that information public, but, in the interests of transparency, I would support that. I think it would be better, yes, to have a clear indication so that the public, in the interests of patient safety, can visibly see the route and compliance either through clinical literature or trials.

Q46 Chair: I noticed that Mr Ellingworth was nodding at that point. Transparency of data is a simple thing, but would more stringent regulations risk losing some of the industry to overseas manufacturers?

Peter Ellingworth: Of course we would have to take a look at what was required, and "proportionate" is always a good approach. Safety comes first. The industry is going to support anything that improves safety. We are supportive of improving transparency. The devices directives have been around for 20 years now and have been through a number of improvements. With any process, we are supportive of continually improving it. There might be some requirements that could be an issue for smaller businesses because they have more limited resources. Essentially, the UK is made up of 2,500 small businesses in this sector, but, of course, every problem has a solution. We would be very positive about anything that improves patient safety.

Q47 Chair: Your understanding would be that we could mandate the issue of transparency to British companies, but as to things that have been approved in other member states, could we mandate it to them?

Mike Kreuzer: No. It is a pan-European system and works in the same way right across Europe. Transparency is an extremely important topic. Greater transparency will be introduced in the revision that is currently taking place. There are plans for that, which I am sure you will be hearing about later from the European Commission, and it is something we completely support. There is definitely a need for greater transparency.

Q48 Stephen Mosley: Mr Howlett, could you briefly explain the resources and expertise that the BSI have in order to assess implants?

John Howlett: I am sure you have read the guides we have put through. A conformity assessment essentially is made up of two parts. Most manufacturers would go through an Annex II route, which would require a quality system assessment. We have in excess of 200 assessors around the world doing medical and conformity assessments. Then it is based on the technical documentation and on classification. As to an implant, generally we are talking of IIB, which is high to medium risk; if we are talking about any of the up-classified items, like hips, knees, shoulders and breast implants, we are talking about class III. As to our expertise, we have highly qualified reviewers from industry and the universities where they have been involved in the design and development of those particular products.

Q49 Stephen Mosley: Moving on to the faulty metal-on-metal hip replacements, in particular the degree of recall, do you think a breakdown in regulation allowed these faulty metal-on-metal hip implants to be used in the EU market for so long?

John Howlett: We have talked about transparency. With any device there needs to be a strong post-market surveillance system. Much work has been done, and all of us as notified bodies are looking at that in greater detail against current expectations. Post-market, it is all about having early warning systems, gathering of data and registries, and that information would give an early warning about the medium and long-term events that would happen with a device.

Going back to the equivalence or clinical trials, we have to realise that the metal-on-metal device has been around for decades. What we have seen recently is not an indication of a failure in all those devices. The devices have performed against their essential requirements-the test methods-and we and the manufacturers would have tested against those standards. Short-term compliance on wear and fatigue is all carried out in the design phase.

The medium and long-term effects have to be coming from post-market. It is unreasonable to think that we can predict 10-year performance if we are looking at hip joints and, say, 90% success after 10 years. It is not reasonable to think that you can do that through a clinical trial. It is a combination of test data and doing all you can to demonstrate patient safety in the short term, and then monitoring for any further medium to long-term effects through the post-marketing phase.

Q50 Stephen Mosley: You have said what needs to be done and you have given a good idea of what should be done. What was actually done in this specific case? Was all of that done or not?

John Howlett: I cannot answer on specific cases. As a notified body we work with a number of clients. I can talk in general terms. The notified body would assess the manufacturer’s data-bench testing-because, obviously, you do not want to put any patients at risk initially. You do all that you can through bench testing, literature and clinical trials as best you can, but you will not get trials that will continue for 10 years. Patients have to be considered in this, to bring innovative and good technology to patients’ use, and to follow up the medium and long-term effects is not reasonable. In any situation where we have a manufacturer, we would assess the company’s system, design dossiers and technical files against those essential requirements.

Q51 Stephen Mosley: I can understand you not wanting to talk about particular things, but can I specifically ask about the impact on BSI? Do you think that BSI has suffered reputationally because of the recall?

John Howlett: I would hope not. We are in a high-risk business. The products that go to the market have to show benefit over risk, and that is a judgment the manufacturer has to make. It is a judgment that the notified body has to challenge and agree with if it is to certify that product. We are assessed in doing our duties as a notified body by the MHRA. We are rigorously audited both in the office and on site for the audits. I believe that our application of those duties is in compliance.

As to reputation, I could not really answer that. I hope people would see that, as a leading notified body in this industry, that would be recognised, and recognise that, although we get small numbers of devices that may show some fault, in the main, the system is generating devices for patients to ensure patient safety across many hundreds of thousands of patients in the EU, which are performing perfectly satisfactorily.

Q52 Stephen Mosley: Could I just ask the other witnesses, and also add this: what do you think the public accountability should be of the notified bodies?

Peter Ellingworth: Public accountability is taken care of in the Medical Devices Directive. One thing I would like to comment on is the National Joint Registry, which is a fantastic aspect of what we have in this country. Clinical registries, led by the cardiac one several years ago, are a great way of ensuring patient safety and continuing to ensure it. Again, they can be built on. The National Joint Registry is now mandatory, and it looks at revision data. We are now engaged in discussions to see how that can be improved further to continue to try to pick up aspects. Mr Howlett is correct in saying that the real challenge is about doing a 10-year clinical trial, but the National Joint Registry is there and is a real asset for us in this country, and we can continue to work on improving it with clinical professionals as well.

Mike Kreuzer: It was the NJR-the National Joint Registry-that picked up the metal-on-metal issue in this country.

Q53 Roger Williams: I was fitted with a metal-on-metal hip about four years ago. It seems to be working very well, but last year I was recalled to the hospital where it was fitted and I had an x-ray and blood samples were taken. At the same time, I received a letter from somebody volunteering to represent me in any legal case I could take against the firm. Can you tell me from where that information was likely to come, and should my medical history be in the public domain?

John Howlett: I personally could not answer that.

Peter Ellingworth: No, I do not understand where that information would come from. Mike Kreuzer: I have no idea.

Peter Ellingworth: I believe that in the case Mr Mosley mentioned, they are taking great pains to make sure that patients are looked after, but they would not be sharing any information about patient names. That really is quite strange. I do not know where that would come from.

Roger Williams: Thank you. I will continue my inquiries.

Q54 Sarah Newton: I would like to pick up where my colleague left off on auditing and particularly ask John Howlett about how the MHRA audits BSI and, in turn, how you audit manufacturers.

John Howlett: I believe the MHRA is one of the strongest and most recognised of the competent authorities in Europe. It audits us regularly with auditors who understand the quality systems side and with product experts to assess what we are doing in terms of a review of the dossiers. It would also send in its clinical experts to look at our review of clinical data that we talked about earlier. I believe that is a very robust system. Representatives from other member states have joined those audits by the MHRA. We are one of the few where there has been a common playing field and even, consistent application, with people coming from other competent authorities in Europe. In addition, it audits us on all the medical directives. We are talking here mainly about MDD 93/42 for implants. It would observe us carrying out audits of manufacturers during our surveillance cycle.

Our audits of the manufacturers follow all the guidance in terms of the harmonised standards that support the directives. We are auditing the manufacturer against the requirements of the directives and all the MEDDEV guidance that goes behind that. We are involved in improving the guidance. We work with the Commission at NB-Med and Team-NB meetings in pushing for and getting better guidance in that area. Obviously, we are not the authors of that; we help and inform, but we operate against that guidance. As a notified body that is all we can do, and we lobby for improvements in the areas that we do.

I think BSI has been very strong and instrumental in doing that. You have probably seen from the papers we have provided that on NB5 we have a code of conduct that is generated by the notified bodies to improve the regulation, so it has come from within the notified bodies. In the absence of greater control from outside, we have helped generate that with a number of the other leading European notified bodies to the point where the Commission are looking very favourably at that initiative to improve the consistent application of our work against the directives.

Q55 Sarah Newton: How many of the BSI members you have approved through the audit process have you subsequently found to be wanting in some way and not meeting your high standards?

John Howlett: That happens. I could not give the numbers offhand, but that does happen with any robust auditing process. It has to be recognised that the majority of manufacturers wish to take a product to the market that is going to be in the patient’s interest; they do not want to have problems with their products. Taking on that aspect and the fact that the notified body is doing all that it can to do that leads, hopefully, to an improvement in patient safety.

Q56 Sarah Newton: It would be helpful if perhaps subsequent to this meeting you could provide that information.

John Howlett: I could give more information on that. When we are looking at situations where a manufacturer is found wanting, the first line of approach as a notified body is to bring that manufacturer into compliance. We do not want to be denying the patient the product; we want that product, if it is a good one, to be brought to the market in a safe condition. We would work with them and agree corrective action plans. Very often in that situation, if the temperature gets too warm for a client that is failing, most would comply with a corrective action plan, and we would work with them to get back into compliance. If that did not happen, it would not be unknown for the manufacturer to look elsewhere for another notified body. Clearly, there are choices. Currently, there are 78 notified bodies, not all full scope against the directives, but there are other alternatives. That is one area in which we have lobbied for further support, because a manufacturer can choose to go elsewhere, and before we have time to suspend or withdraw a certificate we may find that that client is cancelling its certification. That is the major type of non-compliance that ends up with us not being the certification body for that company.

We are working on that. It is most important to have greater transparency on that as well. I think the code of conduct to which I referred earlier is one way of improving the situation to avoid that downward spiral in shopping for an easier route. Very often that can be in terms of clinical data as well, if the expectations become too much. That is something about which the Commission are very aware. They are working on it, and we support them in their approach to that.

Q57 Sarah Newton: I am sure that is very reassuring to all of us who have had anything inserted inside us. Sometimes you approve overseas manufacturers. Do you also audit them to the same high standards?

John Howlett: That is something that is not fully understood. As a notified body, we are designated by the competent authority in the UK to do our work. As a notified body, any manufacturer in any country in the world can apply for CE marking through BSI. You do not have to go to your national body; you can go to any. That is a factor. We do all our audits to the same standard. The qualifications of the reviewers and auditors are exactly the same, whether they are supplied in the European area, Asia or the US. In the medical devices area the US is a big market; there are many clients there. I can reassure you that what we supply in terms of the audits, irrespective of the geographical region, is consistent.

Q58 Gareth Johnson: I would like to concentrate on an issue that you have just touched on: the lack of a central body and the need to use notified bodies, the argument being that there is a path of least resistance somewhere and a manufacturer can shop around. You said there were 78 organisations, if I heard you correctly.

John Howlett: I think that is the current total.

Q59 Gareth Johnson: Can you let the Committee know what kind of relationship the BSI has with the various notified bodies? What dealings and workings do you have with them?

John Howlett: I think we have already covered some of that, as you will appreciate. We go regularly to the NB-Med meetings in Brussels. I represent BSI on that committee. We are members of a voluntary organisation called Team-MB also, which is there to benefit and improve the guidance we give to notified bodies. In addition, I mentioned the NB5 where, as an initiative, we have tried to define the requirements for reviewers and auditors and achieve a common playing field and consistency in those audits. I think we have a good relationship and we respect the other respected notified bodies. It is perhaps not too clear whether all are operating at the same level. It is a perception that many have that it is not a level playing field. I think our relationship with the other leading notified bodies is to try to achieve a transparency that will give greater awareness of the designation of those bodies in order to achieve consistency in their delivery.

Q60 Gareth Johnson: You mentioned the weaknesses of the notified bodies, but is your opinion that, if you did have a central body in Europe, for example, that would give an overall better performance? Would you support having a central body in Europe?

John Howlett: Whatever process is put in place-I am sure a more robust system will come in-it is not really for BSI or the notified bodies to judge what that should be. How it is achieved is not too important, but there is a need for transparency and for the competent authorities to be accountable for the designations that they give within their own member states. In the legal or regulatory framework each member state is responsible for designating its own notified bodies, and they are the ones that are designating and monitoring. In my view or in the view of BSI, there is not sufficient oversight of that activity. Who should do it, I suppose, would be open to discussion.

Q61 Gareth Johnson: What if we moved to a situation where we retain the notified bodies but also have the check and balance of a central body?

John Howlett: I was talking of having a central body or accountability for the decisions on designation. What you are touching on is perhaps a central designation or another step in the licensing or approval for the high-risk devices. That would be a different discussion.

Q62 Gareth Johnson: If you had a situation where you still had those notified bodies but a central body, too, what impact do you think that would have on the notified bodies in terms of their accountability, responsibility and so on? Do you think that would diminish or increase?

John Howlett: I think the current system is robust. We must not lose sight of the fact that the process has been in place for 15 years plus. You have to look at the successes that it has achieved and perhaps not necessarily get drawn into the unfortunate performances of one or two devices. Widespread non-compliance is not there; the vast majority have been compliant. We have to take that into account first. If there was another step-if you like, a central review-we would not be against that. If you look at the current system, that process is already in place.

For a device that has a medicinal substance in it, we have to do a medicines consultation with the Medicines Agency; if it has animal tissue or human blood derivatives, then again we have to involve another authority. I can see a situation where, if you have new technologies and specialist areas, you would draw in another authority to aid that decision. I do not think it is for us to judge what should be the regulatory framework, other than saying that we should work with what we have got and at ways of improving it in some of the ways we have put in our papers to the Commission and yourselves in preparation for this meeting.

Q63 Chair: Mr Howlett, you are a very experienced engineer with a lot of time under your belt working in high-level quality assurance, including your work in BSI. You are sort of implying but not saying that somewhere in those 78 there are notified bodies that do not meet your rigorous standards.

John Howlett: Yes, I am. That is certainly an implication there, and it is a perception in the whole industry. I think my colleagues here may well wish to comment on that. The only evidence we could have for it is that, where manufacturers have sought CE certification and perhaps have been going through the equivalence route, as we have called it, or the clinical literature review without clinical trial data, and we have felt that is necessary to meet the requirements of the directive, it has perhaps led to manufacturers going elsewhere and for the product to appear on the market some two or three months later perhaps with a CE mark from another body, without any further clinical trial data. The only conclusion we can draw from that as a notified body is that the other notified body that has picked up that manufacturer has accepted data that in our view are not supportive of compliance with Annex X of the directive.

Q64 Chair: And greater transparency would aid that process.

John Howlett: Greater transparency would help enormously in making that visible to people.

Peter Ellingworth: Certainly we would agree with the statements about improving the overall quality. Patient safety is of paramount importance here. It is not just about bringing technology on to the market; it has to be safe. Anything that is done to improve the quality of the notified bodies is a step in the right direction. In the work we are doing within Europe at the moment in Brussels-my colleague Mr Kreuzer will comment as well-is about reducing the number of notified bodies, which is something we will support, and about increasing quality. It is an iterative process, as we said earlier on. Everything we can do as we get examples of how to do things better we shall continue to pursue.

Mike Kreuzer: Coming back to the point about a central body, we do not believe that is needed. What is needed is better co-ordination. The system as it is set up at the moment is actually pretty good. What is needed is better coordination between the competent authorities and how they designate the notified bodies. That is my first point here.

That will lead to fewer notified bodies because, as you get stricter designation, there will be a process of attrition and a lot of them will fall out of that. Although I would not want to be quoted on this, I have picked up rumours that at least two or three notified bodies have got out of the medical business in recent weeks because they can see which way the wind is blowing. We would support that. We think that in absolute terms there are too many to run the system properly, and there are too many in the sense that many of them are not doing the job they should be doing.

Q65 Graham Stringer: This is very worrying because people’s health is at risk. In this Committee you are speaking with full parliamentary privilege. Can you tell us which notified bodies you do not think are hitting the right quality standards?

Mike Kreuzer: No, I cannot tell you that precisely, but certainly none of the ones in this country are involved.

Q66 Graham Stringer: Can you tell us about ones in other countries? The issue is that people are going to these bodies in other countries and that enables their products to be used in this country, does it not?

Peter Ellingworth: The companies we represent take patient safety incredibly seriously, and finding a quick or easier route is not in their interests and not in their long-term interests because it is not going to be an aid to patient safety. Your point, Mr Stringer, is absolutely right. This is about making sure that everything can be done to make devices as safe as possible. There is no intent on the part of the companies we talk to and deal with to do anything to circumvent that process, but in the European Union there are 27 member states. We do not have sight of those. We have comments from people as we meet them in Brussels, and we are expressing our general concern. There is not a great body of evidence that says that body A and body B are more or less qualified, but because we have a concern we are raising it. If we had the examples, we would certainly share them with you.

John Howlett: The only thing I can add-it has been expressed in Brussels-is that, if a leading notified body loses a manufacturer to another notified body, it knows that it has lost that manufacturer but it does not know where they go. That is a very clear statement that the transparency is not there. From that perspective in the UK, perhaps that question would be best put to MHRA, who would be coordinating with the other member states on that particular issue. I do not think we could give you any more information on that.

Peter Ellingworth: Moving notified bodies is not necessarily that easy. We talked to one large manufacturer recently and had a very comprehensive discussion on these matters. They said they wanted to work with a strong notified body. They are involved in the process and development of a product, which may take seven years. The regulatory process here is not just a question of developing the device, getting to the end and going through a tick-box exercise. This is a very complex and involved process. They said that to change a notified body would probably take them six months or more and would involve considerable expense, as they understood the new processes and went through the necessary quality assurance. Largely, it is in the manufacturer’s interest to stay with a good notified body because it will have a professional relationship and understand how it can continue to improve.

Mike Kreuzer: The important thing to understand also is that the thrust of the revision-that part of it that concerns notified bodies-is to tackle this very problem.

Q67 Chair: Formally or indeed informally, has there ever been a case where a whistle-blower has come forward and said, "I’m not happy with the way this has been transferred to another notified body"? Has that come to your attention privately or otherwise?

Peter Ellingworth: It is a great question, but no.

Mike Kreuzer: Notified bodies have been de-notified. That has happened.

John Howlett: I would support the comments made. The majority of manufacturers want to do the job right. They want to be with a strong rather than weak notified body for the purposes of demonstrating patient safety and the robustness of their system. They do not want to be left exposed by a cut in scope of the designation of a notified body. We need to put in perspective how often this occurs. I do not want to indicate that this is a massive problem at the moment in terms of extent. We talk about improving the system. We have all recognised that that is an area where it can be improved. I do not want to overstate the number of times it happens, but it can happen. That is the issue that I would like to raise.

Peter Ellingworth: Companies want to work at the highest level they can because they are operating in a global environment. With today’s instant media, a story can travel very quickly. If it is a global corporation, it immediately has a global reputation. For many British businesses, their ability to export is also at stake here. One of the things this Government and the prior Administration have done is to pick out the life science industry and medtech as being the cornerstone of sciences in the UK. There is a massive opportunity here for UK businesses to do well on a global stage, but, to do that, patient safety has to be number one. The effectiveness and positive impact for patients and health systems is the second thing in there, and being seen to be part of a good process is only going to stand them in good stead as they go out into the wider world.

Q68 Stephen Metcalfe: For absolute clarity, in the example you gave where someone moved from you to another notified body, was that a British company?

John Howlett: It has happened. I cannot recall one with a British company, no.

Q69 Stephen Metcalfe: But, where it has happened, the motivation in your view has been that your requirements were too stringent and it was easier to get it approved somewhere else?

John Howlett: It has certainly happened, and more than once. We are required to give information to the competent authorities on certificates granted, suspended, withdrawn and refused. There is a mechanism in place to share that information, but it is not strong enough in the eyes of many people.

Q70 Stephen Metcalfe: In light of that and the fact that you can see quite a wide range of quality thresholds that some of the notified bodies might apply, post-market surveillance is even more important. I am sure we all agree with that. Presumably, that is how we ensure that the product once into market is performing in the way it was predicted to perform. Can you take us through what that process of post-market surveillance is, please?

John Howlett: Yes, I can go through that. With regard to the guidance for post-market surveillance and particularly post-market clinical follow-up where we are talking about a plan for a specific product, if we are looking at post-market surveillance in the wider sense, it is gathering all information. Post-market clinical follow-up is a requirement where we have a plan post-market for a new product going to the market. All of that can come forward in terms of gathering that information. How do we cover that? We do it in many ways. There are requirements on the manufacturer in regard to any incident or complaint. Obviously, the complaint has to be recorded in the hospitals and authorities; otherwise, it does not get to the notified bodies or manufacturers. That is the first area. A lot of people would have a view on that-that not enough incidents are being recorded at the point of the incident.

Q71 Stephen Metcalfe: On that very specific point, is that a passive or proactive process?

John Howlett: The complaint, obviously, is not proactive, but there are other mechanisms to gather that information from surgeons, groups and whatever. That is what I would describe as gathering post-market production experiences. If you are looking at specific product-related follow-up, this is something you have to use. You cannot have a clinical trial; you cannot deny a patient a product for 10 years while you go through a trial. It has to be a combination of clinical data plus follow-up. We would be looking for the manufacturer to give us a robust plan where they will gather that information, probably from a range of patients, almost like a trial to gather that information in. How would we look at that? In a number of ways. Our audits from the quality system side will be looking at the complaints and vigilance reporting of those incidents that gets through to the competent authority. The MHRA as our competent authority requires us to be copied in on all those incidents. That is not a mandatory requirement in the regulations, but it is a requirement on all UK notified bodies. We monitor that through our surveillance, so that information comes in on the complaints.

On the other post-market gathering of information, again you follow that through on the audits but on a product-related basis. If you are looking at a product-related certificate-the class IIIs, where you have a design examination certificate-there is a periodic review of those certificates. The maximum period is five years, and that is what we adopt. In those five years the company can make changes and extensions to ranges or changes to the design. At each one of those events or prompts, there will be a review of the performance of that particular product. It is very much proactive in gathering that information and for us as a notified body to monitor it.

Q72 Stephen Metcalfe: Is that information then made available to clinicians, or even the public, in a centralised form so that they know they are getting the best possible product and have the best possible opportunity to choose?

John Howlett: What we are talking about is the visibility or lack of visibility of that information outside the notified body and manufacturer’s area.

Q73 Stephen Metcalfe: But can a clinician access that information easily or not? I understand what you are saying.

John Howlett: No. There is no framework for them to require or gain that. They could go to a manufacturer and ask for that information. I can’t answer for what success they would have in those requests.

Mike Kreuzer: Again, that is one of the improvements foreseen in the revision of the system of the directives.

Peter Ellingworth: I come back to the registries. They are a great way not just to track patient safety but also to look at how things can be improved for the future. There is a lot of work to be done there, and we are very supportive of some of Earl Howe’s recent review and improvements there. I think there is an opportunity. As to the revisions, let me give you an example. This is a pacemaker from 20 years ago. It is quite a weighty thing. You would not want to pop this in your top pocket. That is today’s. There is a huge move towards improvement for patients and outcomes. The battery life is a lot longer. There is less need to go and have more invasive surgery today; it is more comfortable. The changes made to devices are there for real, positive patient reasons. Patients are at the centre of what we do as an industry. If they were not, this industry would not be what it is. Every day in this country, 38 million people have contact with anything from a simple to a complex medical device.

Q74 Stephen Metcalfe: I accept that, but what we are trying to do is work out what happens when it goes wrong or there is something at the margins.

Peter Ellingworth: And that is where we have to be continually vigilant. I completely agree with you.

Q75 Stephen Metcalfe: Therefore, I am sure that for the vast majority, the relationship with the registries will be a positive experience. How do the manufacturers and registries see their relationship? Is it as partners working for the benefit of the patient or as regulator and regulated?

Peter Ellingworth: As partners. The original device was the size of a car battery, but there is a unique relationship here, unlike many other industries, where clinicians and companies are focused on the patient at the centre of this exercise and how they work together. Nothing is developed purely on a bench; it is a combination of that professional relationship between the healthcare physician and the company, and it is a very intricate relationship.

Q76 Stephen Metcalfe: If they are working as partners, and the registries are collecting data about how products are performing, whose responsibility is it to analyse that data? Is that through the registries or is that then returned to the manufacturer to do that?

Peter Ellingworth: It depends on whose data it is. The registries clearly are owned by the clinicians, and the manufacturers will analyse their own data but will be continually sharing it as there are elements of it from which to learn. The improvements that are coming or we hope are coming will certainly be part of that. Going back to the points that have been made, we will support the transparency.

Q77 Stephen Metcalfe: Do you think there needs to be a mandatory element to that? Do you think clinicians should have to report?

Peter Ellingworth: The National Joint Registry is now mandatory.

Q78 Stephen Metcalfe: For manufacturers?

Peter Ellingworth: No; for clinicians.

Q79 Stephen Metcalfe: They have to report? There is no one who is not-

Peter Ellingworth: For hospitals. That was changed very recently.

Q80 Stephen Metcalfe: As I understand it, across the whole industry there is no formal system for that; there are good and bad examples, and this is a way of identifying presumably what is effective?

Peter Ellingworth: Yes, and they need to be proportionate. If you are dealing with a simple cotton swab, you would not go through the same process that you would with respect to a complex implantable device, but, as ever, there are ways to improve. How we have got to the great state of the industry with its high safety record for patients today is by continually reviewing and looking back to see how we can do this differently. Any negative incident is, of course, incredibly regrettable, but you have to balance that against the number of people who are benefiting and are pain-free. We talked about hips at the beginning of this. It has made a significant difference to people’s lives.

Q81 Graham Stringer: Should there be a central European registry for all medical devices? Would it be helpful to have a unique device identification on all those devices with that information held centrally in Europe?

Peter Ellingworth: UDI is coming, and we are actively engaged in that. There are many positive aspects to that. Mike in fact works in Europe.

Q82 Graham Stringer: What is the schedule for that?

Mike Kreuzer: Incidentally, I chair a European industry group that is driving this at the moment. The schedule for unique device identification is that it will now be part of the revision; in other words, there will be a specific clause in the revision to require devices to carry a unique identifier machine-readable code. The revision will take up to four or five years to come fully into force, but a lot of work is being done at the present time to drive this ahead. I believe it will be of enormous benefit-it is not the complete answer-in setting up new registries. To follow on from the previous point, this is a fairly uncharted area at the moment and we do need registries. To come back to your point about a pan-European one, that would be an ideal, but it is probably something that would not be easily achievable. What might or should be achievable is to have registries that are interoperable.

Q83 Graham Stringer: To follow up on Stephen’s question, who should have access to that information?

Peter Ellingworth: Registries today are available and are transparent.

Mike Kreuzer: Manufacturers, clinicians and regulators. This is something that needs some advancement and new design, if you like. We are just moving into that period now.

Peter Ellingworth: It is certainly a question, again, for the healthcare professionals. There is a lot of information in there. To make it available to the public, there may be some questions about educating people to understand that information. I suggest that you talk to them.

Chair: Gentlemen, that has been a very helpful session. Thank you very much indeed for your evidence. If you have any other thoughts about some of the issues that have been raised, including some of the sensitive questions we asked, we would be grateful if you would follow that up in writing.

Examination of Witness

Witness: Jacqueline Minor, Director of Consumer Affairs, Directorate-General for Health & Consumers, European Commission, gave evidence.

Q84 Chair: I welcome you to our session and invite you to introduce yourself.

Jacqueline Minor: My name is Jacqueline Minor. I am the director in the Directorate-General for Health & Consumers of the European Commission with responsibility for medical devices.

Q85 Chair: Will you start off by giving us a brief summary of what is happening to the Medical Devices Directive, and in what time frame you envisage this matter being resolved?

Jacqueline Minor: As you have probably heard from a number of previous witnesses, the medical device regulatory framework in Europe consists of three directives, the oldest of which was adopted in 1990, so these directives have been in place for about 20 years. They have been amended fairly consistently on specific points, but we believe the time has now come for a more far-reaching revision. We started consulting broadly on this in 2008. We carried out a further consultation in 2010, and we have also had ongoing discussions with stakeholders throughout the last four to five years about what changes are needed.

We have now got to the point where we are about to make our proposal. It should be tabled by the Commission in late September of this year, and then it will go to the colegislators, the European Parliament and Council of Ministers. In the best of all possible worlds, we would hope for adoption by the end of 2013. There will be a period of implementation, so the new regulatory framework will probably not be in full force until the end of 2014-2015.

Q86 Chair: Our understanding of the original directive is that it was all about providing unhindered access to the European market. Is the balance shifting from that towards public health in the debates that are going on?

Jacqueline Minor: The directives have always had twin objectives: securing the safety of devices and meeting public health objectives but also securing the free movement of the product in question-the medical device-in Europe’s internal market. That will remain the case in the new regulatory framework. However, over time, there has perhaps been a shift in the perception of the importance of medical devices to public safety and health, and a greater awareness of the need to ensure that public health, and the safety of patients and other users, are the paramount concerns in putting together the regulatory framework. Experience and recent events in particular have shown us that we can do better, and we want to address a number of weaknesses.

Q87 Chair: You heard some of the concerns expressed by previous witnesses. Do you share those concerns?

Jacqueline Minor: Yes, absolutely.

Q88 Chair: You would want to see issues like transparency and better controls over some of the 78 notified bodies being incorporated in a directive that is enforced rigorously across Europe?

Jacqueline Minor: Indeed. The diagnosis, if I may call it that, of the weaknesses is fairly broadly shared. Everybody involved in the industry and in regulating it-competent authorities across Europe-shares a view as to what needs to be addressed in the revision. We intend to propose two regulations, so we are going to move from directives to regulations. That has the effect of meaning that no national legislation is required to translate the rules into the legal systems of the member states, which will eliminate to some degree differences of interpretation or of application. We want to address particularly oversight of notified bodies and their initial designation by competent authorities in member states, and the way in which they carry out their conformity assessments. We want to address transparency, which I noticed was a recurring theme as I listened to the previous witnesses, and post-market follow-up and surveillance.

Q89 Chair: I have just done some work outside this Committee on health and safety. I am serving on a panel that the Government established to review some of the health and safety legislation in the country. We were looking at pan-European experience in that respect. There appear to be differences between member states in what the law says and its enforcement. Is this your underlying worry in the case of medical implants?

Jacqueline Minor: One has to acknowledge that the rigour of the system always depends upon the resources, stringency and effort with which national supervisory authorities in the end exercise their responsibilities. There is always that issue with internal market legislation.

Q90 Chair: You are implying that there is a spectrum.

Jacqueline Minor: There is a spectrum of resource, competence and size of market, but what we hope to do in the revision is create greater commonality of view and shared resource management but also shared oversight of the system.

Q91 Stephen Metcalfe: In the previous session, I was concerned about post-market surveillance in light of some of those inconsistencies. To iron out those inconsistencies, we need a more standardised approach. It is a pan-European market and therefore I imagine we all want the same level of quality assurance across the whole market. I think you accept there is a role in that for a central body. Do you see a role for member countries to help register and judge each another’s competent authorities and notified bodies to try to get a level of consistency?

Jacqueline Minor: Certainly, for notified bodies, we envisage a system where responsibility for designating a notified body remains with the competent member state, but prior to that designation there would be a joint inspection. Whereas currently, as you heard from the gentleman from BSI, it is the British authorities who carry out the inspection of BSI before designating, or confirming its designation, we would have a system whereby there would be a joint team. You would have a team from the member state concerned but that would also include people from another member state, probably people drawn from a European list. The team would draw up an inspection report. That would be submitted to a group of European experts, who would issue a favourable or unfavourable opinion, or an opinion with reservations. That would go back to the competent member state, which would make a final decision on designation. One imagines that if there were reservations, or the report was negative, they would not go ahead with the designation, and the report would be public, so that would bring some pressure to bear upon them.

Q92 Stephen Metcalfe: Do you envisage a central EU committee overseeing that process?

Jacqueline Minor: We are proposing something called the medical devices expert group, which would be composed of representatives appointed by member states, but in their personal capacity-either one or two from each member state.

Q93 Stephen Metcalfe: Do you see that leading to a lower number of notified bodies?

Jacqueline Minor: To lower the number of notified bodies is not an objective in itself, but it might well be a consequence.

Q94 Stephen Metcalfe: But, if there were a smaller number, presumably it would make it easier continually to assess whether those standards are being maintained?

Jacqueline Minor: Yes, indeed. What we would also expect to see is that, even if there is not a reduction in the absolute number of bodies, there might well be a restriction on their areas of competence, so some of them would be designated only for a more limited range of devices.

Q95 Stephen Metcalfe: Presumably, this would add some additional cost to bringing a product to market?

Jacqueline Minor: Yes.

Q96 Stephen Metcalfe: How do you envisage that cost being paid for?

Jacqueline Minor: Manufacturers currently pay notified bodies a fee for the work carried out, and obviously notified bodies have to cover their overheads when they charge that fee. Presumably, that fee would increase as a result. Having talked to the industry, they feel this is a cost which the industry must bear-would be willing to bear-in order to improve confidence in the system and restore trust.

Q97 Stephen Metcalfe: You do not see it being such a prohibitively high cost that it would put off even the smallest of specialist manufacturers from bringing a product to market in Europe?

Jacqueline Minor: I honestly do not think so, because we are talking about a notified body, as you have heard, which is designated for a number of years. A number of manufacturers go to them for certificates, so when it is spread across all the certificates and all the manufacturers, I do not think it would amount to a substantial increase.

Q98 Pamela Nash: Do you think that the revisions to the directives that are going through at the moment will address co-ordination of post-market surveillance throughout the UK?

Jacqueline Minor: I hope so. We want to change the current system from one where incidents are reported to national authorities and national authorities report them at a European level, so we have a kind of two-stage process, to one where we create a single portal so every serious incident would be reported directly at European level. I hope that would enable us to pick up more quickly any emerging trend that gave concern in relation to a device. We also hope to make some funds available to have some central trend analysis, so that we would have scientists working in our joint research centre looking at the data coming in and being able to check it and sound the alarm more quickly than has been the case in the past.

Q99 Chair: This would be a portal to which clinicians themselves would have access?

Jacqueline Minor: Clinicians, even patients, but mainly manufacturers.

Q100 Pamela Nash: If you had to create that single portal, can you expand a bit on what you see as the practicalities? Who would set this up? How long would it take? What would be the costs involved?

Jacqueline Minor: We would set it up. I cannot remember the exact cost at which we have assessed it, but we would plan to set it up in the period between the final adoption of the legislation and its coming into effect so it would be available when the new regulatory framework goes live.

Q101 Pamela Nash: Is that information that you could send us? Could you share that with us?

Jacqueline Minor: Yes.

Q102 Pamela Nash: If an implant is found to be faulty, in your experience so far, is its withdrawal from the market consistent across member states at the moment? How would the new registry be able to help fix those problems that have been found so far?

Jacqueline Minor: Under the current framework, both risk assessment and risk management are left in the hands of member states. A member state determines what it believes is the risk from a particular product post-market incident report. It also decides how to address that risk. Initially, the onus is on the manufacturer to determine whether they need to modify or recall their own product, but with a large-scale incident, such as the PIP, it was up to each member state to determine the advice it would give to the women concerned. What we hope or plan to do under the new system is move risk analysis to a more central position: that is, the trend analysis. We will also make provision for a common risk management, so in certain cases involving large-scale incidents such as the PIP-maybe metal on metal-we may also have a European recommendation as to how that should be addressed by clinicians, so we will not have the situation where patients in different countries-

Q103 Pamela Nash: Could you explain that a bit more? Does that mean that individual countries would still have the power to take a decision based on information given them from the central registry, or would rules be implemented that meant that you would have to have a uniform approach?

Jacqueline Minor: The proposed regulation will give rise to the possibility of a uniform approach. It will depend on the nature of the incident, but I would imagine that for a widespread incident such as the PIP, we would try to aim at a common European recommendation as to how it should be addressed.

Q104 Pamela Nash: But the power would still lie with individual countries to take that decision.

Jacqueline Minor: There would be a recommendation, and I think it would then be difficult for individual member states to ignore it.

Q105 Pamela Nash: On the question of co-ordination throughout the EU, do you think there should also be a policy on healthcare professionals having to report if they find a fault in the devices they are using?

Jacqueline Minor: Yes. Currently, the rule is that manufacturers must report serious incidents. What we want to do is open up the possibility of healthcare professionals and patients themselves reporting incidents. That is not without its difficulties, because a patient often cannot tell whether the problem is with the device itself or the care they receive from the health system. It is difficult to make that obligatory because of the legal basis on which we work, but we would certainly encourage a co-ordinated approach.

Q106 Pamela Nash: Is that covered in the directive, and is it being looked at in the revision?

Jacqueline Minor: It is being looked at. We will try to have a permissive provision in the regulation, and when we set up the single portal, we will also try to ensure that it enables reporting by patients and healthcare professionals as well as manufacturers. For healthcare professionals it is easy enough to do; for patients it is a little more difficult.

Q107 Graham Stringer: Perhaps I may read you a quote from the Royal College of Physicians: "Despite the lack of hard evidence that the current system of approving implanted devices for marketing within the EU, there is concern that the current system of competent authorities being involved at the clinical trial approval stage and with post-market vigilance, but not directly with product approvals, is unsatisfactory." That leads to the obvious question: should the expertise of those competent authorities be used in the initial approval stage?

Jacqueline Minor: This is something that we are considering in the revision. There are several ways in which we will address that. The first is that we will make available to producers and to notified bodies early scientific advice. We will have a scientific panel, and anyone developing a novel technology will be able to go to that scientific panel to ask about the kinds of evidence they will need to bring forward to support its safety when the time comes for conformity assessment and placing it on the market.

The second and perhaps more significant strand that we are developing is that in future anyone who brings a new class III device to market-that is the highest risk for us-will have to notify their intention centrally. At that point, competent authorities in all the member states would learn of something that is approaching the point at which it will be placed on the market. Currently, a competent authority does not know what is coming on to the market until the goods are there. When that notification is made, it will be examined by our scientific experts. It could be called in for something we are labelling the scrutiny procedure. The file presented by the manufacturer-the design dossier and the clinical evidence-could be called in and looked at by a central body and our scientific experts. The scientific opinion would go to the central committee, the medical device expert group, and they would offer an opinion as to the evidence presented, which would then go back to the notified body. The notified body would have to take that into account in its final conformity assessment and its decision as to whether or not to issue a certificate.

Q108 Graham Stringer: Would it be fair to characterise it-tell me if it is not fair-as that, in the future, you are going to rely on better communications between the different bodies with the knowledge rather than actually involving the competent authority in the approval process itself? Is that a fair way of putting it?

Jacqueline Minor: No. I think there would be an involvement of the competent authorities. First, they would get this prior warning, which they currently do not. Secondly, the medical device expert group that we are creating would have an upstream view and offer an upstream opinion on a device which was coming new to market before it received its certificate and was allowed to circulate in the internal market. What we are not envisaging, which other jurisdictions apply, is pre-market approval, which is where a central body has to grant authorisation to a medical device before it is allowed to go on the market, as happens, for example, in the US.

Q109 Chair: Are there any other aspects of the proposed revised directives that we have not discussed this morning that are relevant?

Jacqueline Minor: You have discussed it, but I would like to emphasise transparency, which is very important. It is very difficult, as I think a number of your earlier questions pointed out, for anyone to know what devices are on the market; what evidence was used to support their safety; and what information is available about the associated risks and the incidents they might have provoked. We are planning to have a central registry in which all manufacturers and all devices will have to be listed. For each device, there will be some standard information, such as the name of the notified bodies, the class of risk, and the unique device identifier, when we have that. There will also be a summary of performance and clinical data. For the first time, for example, clinicians will be able to have access to the clinical data which supported the certificate granted to the device.

Q110 Chair: You have no doubt in your mind that that information ought to be available to both the clinician and patient?

Jacqueline Minor: It is a summary; it is not the full technical file, but we believe it should be made available.

Q111 Roger Williams: I was going to ask whether the information was made available to the patient. Some clinicians will use only specific products. How does that leave the patient if they have made up their mind that a particular product is the one that will give them the best relief and the particular doctor does not supply it, or does not do it?

Jacqueline Minor: To some extent, that goes beyond the ambit of the regulation of the product. That is a question about the healthcare system offering the patient choices and informed consent, of the doctor in trying to explain to the patient why they are using a particular device-in the same way as why they recommend a particular drug-but we know from our broader discussions with stakeholders that the role of the patient is changing. There is a belief and expectation that they have a far greater role in the management of their condition and a far greater say in the therapy applied to it. In line with that trend, I would expect this data to be useful, maybe not so much to individual patients, but you could imagine that associations of patients with a particular condition would offer guidance about the choice between different devices.

Q112 Stephen Metcalfe: You said that this register would hold information on all medical devices. For clarity, you do not mean just class IIB and III; you mean all of them?

Jacqueline Minor: Yes, although the details for all classes would differ of course.

Q113 Stephen Metcalfe: That means there will be many thousands of items on it?

Jacqueline Minor: Yes.

Q114 Stephen Metcalfe: Would the cost of that be covered by the industry itself?

Jacqueline Minor: There would probably be a fee for registration, but what industry is looking at at present is the possibility of having to register 27 times, because a number of member states have set up registries. They are perfectly entitled to do that under existing legislation. Either they charge a fee or, if they do not, there is the administrative burden of having to go through the registration process in each member state.

Q115 Stephen Metcalfe: For a product that is available across the whole of Europe, it could reduce costs.

Jacqueline Minor: It could certainly reduce burden and, one hopes, consequently costs.

Q116 Stephen Metcalfe: We are talking about covering things like sticky tape, bandages, rubber gloves and plasters.

Jacqueline Minor: Yes.

Q117 Chair: A final question: I recognise issues to do with protocols in the Brussels machine, but I suspect we are the only group of parliamentarians across the whole of Europe looking in such detail at this.

Jacqueline Minor: The French Senate is doing so.

Q118 Chair: Excellent. It would be extremely helpful, if you are able to do it, if you would provide us in confidence with a draft of the thinking, with obvious caveats that we would respect the necessary protocols. I think it would mutually help the thinking in this very important area.

Jacqueline Minor: I cannot give you a positive "yes" to that now; it is something I would have to refer to higher authorities.

Q119 Chair: Even if it was a summary. You have given us a summary already, in a sense.

Jacqueline Minor: What is your time scale? There are certain procedural steps we are going through and it might be easier to do it at a slightly later stage.

Q120 Chair: It would be helpful if we had something before September.

Jacqueline Minor: Before September? I will do my best.

Q121 Chair: You understand that it is all in aid of transparency.

Jacqueline Minor: Absolutely.

Chair: We are extremely grateful to you for spending time with us this morning. Thank you very much for being so open with us.

We now move on to our third panel. The Minister and Sir Kent Woods will be joining us.

Examination of Witnesses

Witnesses: Sir Kent Woods, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), and Earl Howe, Parliamentary Under-Secretary of State, Department of Health, gave evidence.

Q122 Chair: Minister, welcome to you and thank you for agreeing to come to see us today. Sir Kent, I would be grateful if you would formally introduce yourself to the Committee.

Sir Kent Woods: I am Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency.

Q123 Chair: We have heard some fascinating evidence on this issue. Minister, in what areas of the revised directive have the Department and, to you, Sir Kent, the MHRA been most heavily involved, and what are your priorities?

Earl Howe: Sir Kent can probably fill out the detail, but the Commission have already given us an indication of where they think the focus should lie in terms of revising the directives. Undoubtedly, there needs to be greater focus on ensuring that notified bodies are fit for purpose. There is a perception of a variation in the performance of notified bodies across the European Union. I am glad to say we do not have any worries about the ones in the UK, but there is a need to ensure that notified bodies are performing as they should and have the right expertise to address the areas with which they are concerned.

Subsequent post-market surveillance undertaken by manufacturers is an area to be looked at. We want to ensure that EU competent authorities cooperate and coordinate their post-market surveillance activities. Sir Kent can probably flesh out some of that usefully.

Sir Kent Woods: Our starting point when we were thinking as an agency about the revision of the directives was to reflect that pharmaceuticals and medical devices are fundamentally different, and the way they are regulated needs properly to reflect those differences. As regards medical devices, the areas in which they differ are, first, the way they are innovated. They are innovated in a rather iterative way with progressive, relatively small changes in technology and refinement, perhaps as frequently as every year or two, which is quite unlike the situation with pharmaceuticals.

The second point is about their sheer multiplicity. When we look at pharmaceuticals we are talking about the low thousands; when we look at medical devices we are looking at hundreds of thousands in the EU. Therefore, the regulatory system has to be able to cope with that.

The third and perhaps most important difference is the way in which they fail when they give rise to problems. In contrast to pharmaceuticals, the areas where medical devices give us problems are, first, in relation to sporadic manufacturing problems, which are not easily picked up at the market authorisation step; and, secondly, particularly in terms of implantable devices, the way they wear over time, and all of them will over time. Again, that is on a time scale that is not easy to pick up in pre-clinical studies.

The other aspect of the failure pattern of medical devices is the much greater involvement of the operator factor-in other words, the way they are used and the way patients are selected for particular devices.

The regulatory system we wish to see for medical devices has to accommodate these rather distinctive characteristics. Our view has been that, in principle, the Medical Devices Directives under the new approach are appropriate, but in detail, as you have heard from the Minister, there are areas where we would wish to see a greater degree of consistency of application and rigour across the piece in certain areas. At the centre of this has to be the designation and the performance of the notified bodies because of the fact that in Europe we are essentially working on a mutual recognition system. A notified body can award a CE mark in any country of Europe-there are 70 or 80 notified bodies-and that gives access to the entire European market. Clearly, the performance of notified bodies is central to the integrity of the system.

Going back to what I said earlier about the distinctive features of medical devices, the balance has to be right between the pre-market assessment of the device-what one can learn before it goes into use-and the post-market evaluation, which requires a high degree of vigilance, market surveillance and the best possible means of monitoring outcomes under conditions of use, and feeding that back both to clinicians and manufacturers.

Q124 Chair: I take it you would agree that, if one saw a product being questioned or refused by BSI, for example, and it went off and got approval from another notified body, that is a pretty unsatisfactory situation?

Sir Kent Woods: Indeed.

Q125 Chair: That process at the very least ought to be totally transparent.

Sir Kent Woods: Indeed. You have touched on an issue we take very seriously for the revision, which is this question of transparency. Criticism has rightly been made that under the existing arrangements, and it is in the Medical Devices Directives, there are obligations of confidentiality on those who run the system. We find this frustrating and unhelpful, and I think the general public and health professions would wish to be able to see more of the evidence underpinning, for instance, the award of a CE mark, and evidence emerging from post-market surveillance, and all this can be incorporated into the revision of the directives.

Q126 Stephen Metcalfe: Are there any proposed changes that you do not agree with and are not in step with the way we do things at the moment?

Sir Kent Woods: We have not yet seen in detail the proposals. I have been in close contact with the Commission as these ideas have been developed. For me, one of the most important issues was to avoid going in a direction that placed a very large additional burden on the pre-market authorisation step. My reason for saying that is partly because there is this iterative process of product development, which is difficult to evaluate in depth pre-market, and also because we know, from the experience of the United States, that going down that route very much increases the time delay of giving patients access to new technologies. There is a balance to be struck clearly between speed of access to new technologies and the degree of protection of patients, but we would wish to see-I think the revisions will address this-a greater strengthening of the post-market surveillance process, but also in detail an improvement in the way the notified bodies confer CE marks.

Q127 Stephen Metcalfe: From what you understand, you think the balance is probably about right.

Sir Kent Woods: I think that is right.

Q128 Chair: I want to pursue this a little more. Last night Mr Mosley and I heard a very interesting presentation about the work going on by our colleagues in the Home Office to bring up to date the directive covering experiments on animals. These discussions and debates are tortuously difficult, and making sure that we end up not harmonising down to a lower common denominator than the public would expect us to do is very difficult. We recognise in this case that the evidence we have had suggests that some of the notified bodies are not as rigorous and effective as our own. Earl Howe, if the outcome was the right level of regulation but it was more centralised within the European machinery, would that create problems for you?

Earl Howe: It would be likely to result in a more costly system, because you would have to populate whatever European body was charged with this job with the right experts. We would prefer to see a model involving much more efficient cooperation between member states. To come back to what Sir Kent said on transparency, this was a point that ran through my own report on PIP implants. If there was one expression that summarised my recommendations on that, it was "greater transparency". If we can get greater sharing of data between member states, maybe even have an EU portal where data can be fed in when there is an adverse report on a device so that it is clearly on view to all member states, that would be much more efficient and effective and much less cumbersome.

Q129 Chair: A portal that included good as well as adverse information?

Earl Howe: Yes. Why not?

Q130 Chair: You would prefer that kind of European coordination rather than a new body?

Earl Howe: Yes, I would. Reading the opinion and talking to medical devices companies, that is what they would say they would prefer, largely because they fear that a centralised European mechanism could act as a brake on innovation and add to costs unnecessarily.

Q131 Chair: Has your thinking on this been affected by your experience of dealing with the metal-on-metal hip joints and PIP?

Earl Howe: Yes, undoubtedly. One of the lessons of the metal-on-metal hip joints can be drawn by making a comparison between the situation in this country and in the United States. What we have in this country is a regulator-a competent authority in the shape of the MHRA-that has very close, active links with the professions, royal colleges and experts of all kinds so that early intelligence is available on any problems in medical devices. We have seen with metal-on-metal hip joints a dramatic drop in their use of ever since it was first suspected that there might be a problem with them. That is not the case in the United States. I think the latest figures in my brief are that in this country 60,000 or 70,000 joint replacement operations go on in a year, of which 2% are metal-on-metal at the moment, and dwindling. In America it is 35%, because in the United States their post-market surveillance is much weaker than in this country. It is a case of being able to react swiftly, as Sir Kent has said, in the face of any problems while also ensuring that new technology is available swiftly to patients, and that many of our medtech companies, SMEs mainly, are able to start up and get going in a way that does not present them with unreasonable regulatory burdens at the outset.

Q132 Gareth Johnson: Perhaps I can ask you some more general questions about the MHRA. In particular, where does the MHRA get its expertise from? I understand that you have a Committee on the Safety of Devices. How important is that in providing the MHRA with the expertise it needs?

Sir Kent Woods: Thank you for the question. We have in-house 104 staff working on medical devices regulation at the moment, and of those about 60 are specialists; they are scientists, engineers, technical in their background. Because of the enormous scope of medical devices technology we must draw extensively on external expertise, not only to provide us with scientific and technical knowledge about the devices themselves but to provide that sort of clinical interface so that we are aware of issues arising in clinical practice.

We have several ways of doing this. As you mention, we have a Committee on the Safety of Devices which has been in existence for nearly 10 years. This is a group of 25 external experts from clinical and scientific disciplines, who meet regularly. We take to them issues of general principle, and where we have a concern about a specific area of technology usually there will be somebody on that committee who can lead us in to the relevant expertise externally.

We have a wider panel of experts whom we consult on an ad hoc basis, depending on the nature of the problem, and we also have very strong links with the professional bodies. If we take the metal-on-metal hip incident and the investigations we have done on it, we have worked very closely with the British Orthopaedic Association and British Hip Society, and the guidance we have put out has been jointly between the clinical professional bodies and the regulator, drawing on the expertise of both. That interface with experts and clinicians in the field makes a huge difference to the way we do our business.

Q133 Gareth Johnson: I get the impression that you are quite a private organisation, if I may put it that way. You publicly state that the work of the committee must remain confidential at all times. Is that purely for commercial reasons, or is there any other reason why that is the case? Is it possible that that committee could be a little more open?

Sir Kent Woods: It goes back to what I said earlier about the obligations placed on us by the Medical Devices Directives. I think article 20 of the main directive requires that information obtained by regulators is confidential. I would like to see that changed. In the revised legislation I would like to see that the default assumption is transparency rather than confidentiality. That has really somewhat set the tone for the way in which we regulate medical devices. To an extent the same thing has happened in our pharmaceutical regulation. The Medicines Act 1968 again imposed a legal obligation of confidentiality, which has changed. I think we are seeing that process happening also on the medical devices front.

Q134 Gareth Johnson: That is quite interesting. If there was a change, what aspects of the work that you do at the moment that you currently keep confidential do you think you could put in the public domain?

Sir Kent Woods: For instance, with pharmaceuticals we put into the public domain routinely tabulated analyses of the adverse drug reaction reports we have received on all the medicines we regulate. That data is there; you can look at it on our website. Although we have to hedge it around with cautions about how it can be interpreted, none the less the information is there.

On the medical devices side, to be able to give greater public visibility to accumulating experience would be valuable. Going back to the metal-on-metal case-this is a really instructive issue-in the UK we have the National Joint Registry. It is not within the MHRA, but we are closely involved in it and have representation on it. The National Joint Registry is the biggest in the world now. It has over a million hip, knee and ankle replacements in its register, and it produces an annual report, which sets out in very great detail the follow-up results of those procedures by type of operation, type of device and manufacturer of device. That is a valuable resource for changing clinical practice. That is the way in which accumulating information on outcome is fed back to improving care and, therefore, improving outcomes.

Fundamentally, that is what regulation is about. Regulation is not about standing as policeman over the industry; our motivation is to make sure that the end results in terms of clinical care are the optimum. So the transparency that now exists around the outcomes of joint replacement surgery through the National Joint Registry is a model of what might be achieved in other areas were there to be better follow-up data presented in a more coherent and consistent way.

Q135 Gareth Johnson: Do you ever privately share information with any other competent authorities?

Sir Kent Woods: Yes, indeed.

Q136 Gareth Johnson: Can you give any examples of that?

Sir Kent Woods: We have an obligation to notify competent authorities if we hear of serious adverse incidents that might affect products on the market in the other countries of Europe. There is that communication. I do not think in practice it is as regular and detailed as it could be. One of the aspects of the legislative review has been how to improve the interaction between the national competent authorities across the 27 member states. As you might expect, some of the national competent authorities are larger; they have better resources and more data, but we are dealing in a European system and it is important that we draw on experience from the whole population of 500 million and share our resources. We have been exploring among ourselves as heads of the national competent authorities how best to do this. I am sure there will be progress within the next months and years in further formalising the interactions between the national authorities.

Q137 Sarah Newton: I would like to pick up the very welcome comments you made that the key way forward is improved transparency. This has come out very strongly from all our witnesses, but I would like to move on to transparency in the process of how you go about selecting the notified bodies and the notified bodies themselves. We have heard a lot of criticism, especially from clinicians and the royal colleges, about the lack of transparency in the pre-approval process. Why is there not more transparency in the process?

Sir Kent Woods: There are probably two subsets to that question. One is transparency about how notified bodies are designated and how we audit their capabilities over time. The other bit is about how the notified bodies assess products that are brought to them, how they evaluate the design dossiers and how they evaluate the company quality systems with which they are faced. As I touched on earlier, the relative lack of transparency dates from the original legislation, which has seen much of this as being commercially confidential information, but expectations change and this is information that will influence the way clinicians do their jobs; it will influence the way patients make decisions about healthcare. I think we have seen a shift in social expectations over the years, which means that we must explore every opportunity to get that information into the public domain, with some protections remaining for what is genuinely commercial in confidence and for data protection purposes down to the level of individual patient outcomes. Those clearly are the red line areas that we have to protect, but the definition of what constitutes commercial in confidence is something that exercises us constantly across the whole area of regulation of medical devices, pharmaceuticals-the lot.

Q138 Sarah Newton: I think we have been reassured this morning by the consistent determination from you but also from industry as a result of the current review of the directives to have greater transparency. However, I was rather concerned by the evidence we heard from the person representing the Commission that the changes were not going to be to the directives, which would give this Parliament an opportunity to scrutinise them, but to regulations, so there would not be an opportunity for us to scrutinise them. If we assume, probably because we are very patriotic, that we are doing things really well in the UK, perhaps better than a lot of other member states, how can we be assured that in these new regulations we are not going to have a reduction in standards compared with our own, because we are not going to have the opportunity as a Parliament to debate and accept our own interpretation of the directive?

Earl Howe: I am aware-Sir Kent can perhaps confirm this-that the Commission are equally concerned that there should be a levelling up in the quality of notified bodies, and that the process of designation and audit should not be up to just one competent authority but it should involve joint assessment teams comprised of experts from more than one member state and, indeed, the Commission, this being overseen by a central EU committee. Those are the kinds of noises we are getting at the moment. I think we should be reassured by that. Whether that is the precise formula we arrive at eventually we do not know, but clearly there is an awareness at Commission level that the point you make is a very valid one.

Sir Kent Woods: The distinction between directive and regulation has two sides to it. On the one hand, I think the motivation is to achieve consistency across Europe, and the theory would be that a regulation would do that more reliably than a directive, on the grounds that a directive has a transposition step where there may be variations that allow excellence to flourish in one part of Europe but may allow the opposite to happen. It is even more important, therefore, that, if there is to be a regulation, the input from the more active member states is very forceful in making clear what the essential requirements of that regulation should be.

As far as transparency goes, everything I hear suggests that there will be a fundamental shift to a more permissive approach to the use of data, whereas what we have at the moment in the directives is a very restrictive legal basis around the use of data. Provided we have that permissive framework, I think member states have the ability to use their best judgment as to how that is done.

Q139 Chair: You regard that point as non-negotiable; it is a top priority.

Sir Kent Woods: The issue of transparency-absolutely.

Q140 Chair: Minister, do you confirm that on behalf of the Government?

Earl Howe: I am absolutely behind this. All the lessons of history tell us that we need to make a fundamental shift in the direction of transparency and away from unnecessary confidentiality. There may be some confidentiality that needs to remain, but the presumption is far too heavily weighted in the wrong direction at the moment.

Q141 Sarah Newton: I want to put one question that came up a few times in the evidence of our witnesses this morning. If a notified body rejected an applicant, they would go to another notified body and somehow get approval. What do you do when you find that has occurred? I understand it is quite rare, but the fact it is going on causes us a lot of concern. What do you do with that information when you receive it?

Sir Kent Woods: We have had anecdotal accounts of this, but it is terribly difficult to get the data, partly because we have a system of 70 or 80 notified bodies across the EU. There is no reliable way of detecting that to the extent that one can say it is not happening. The anecdotes have certainly circulated. I think that is a potential weakness. Whether it is a real weakness I am not sure. I think the solution comes back to the future arrangements for designating and auditing notified bodies. If we genuinely are able to achieve on a multinational basis a consistent standard of designation and audit, the incentives for forum shopping will not be there. It may be that we end up with fewer notified bodies, but we must have a consistency of performance of notified bodies. If we have that, the problem of forum shopping is not a worry.

Earl Howe: There is also a case for specifying in greater detail how notified bodies should undertake conformity assessments and ongoing monitoring of manufacturers, and the use of unannounced inspections and audits, perhaps requiring physical checks of devices. I know this takes us into the territory of greater prescription, but perhaps there is a case for looking at that more closely if we really want to see greater consistency of performance across Europe.

Q142 Graham Stringer: Patients and politicians always want the best of both worlds. Patients want medical devices to be 100% safe. If they are going to save lives or improve the quality of life, they also want them now rather than in two years. How do you balance those competing demands, Sir Kent? We heard evidence from Professor Westerby a few weeks ago that people were moving to Greece because they could use devices to help with heart problems there now that we cannot not use in this country. How do you balance those issues?

Sir Kent Woods: You are absolutely right. There is always a balance to be struck. As a regulatory agency, we are firmly of the view that innovation is a positive contributor to public health, and therefore to the extent we can do so without endangering clinical outcomes we should enable it. That is one of the reasons why I think the existing broad approach to medical devices is right, because the innovation happens in small incremental steps. But the corollary of that to protect the interests of the patients who receive implants is the obligation to make sure there is real, accurate and timely monitoring of outcomes. We are moving quite quickly to a situation where that is technically much easier to achieve. The introduction of IT systems into healthcare and the ability to capture and process large amounts of data gives us huge potential to make sure that outcome monitoring, and indeed traceability if necessary, is achieved much more consistently. But it requires partnership working between the active participants-the regulator working with the industry, the notified bodies and the clinical community to make this happen. The capture of event and outcome data fundamentally rests with the clinicians and to some extent with patients. We all depend on that happening, which is why these good working relations that we have with the clinical community are so important to us.

Earl Howe: Sir Kent said earlier that it was less a case of amending the structure of the legislation than making sure that the regulations work as intended and as they should. What that implies in the context of your question is looking at the legal underpinning of all this in relation to the relative risk of different types of medical device. What we have is an intent at least to ensure that the pre-market data that a regulator or a notified body receives is commensurate with the risk associated with the innovation or change.

We can take that only so far, because, as Sir Kent said at the beginning, it would be lovely to be able to predict the likelihood of failure of a device in premarket studies, but it is totally impracticable to do that. Even if one were to try to do it, it would be so onerous that the product would probably be unable to complete the development process. It is important to achieve that balance between pre-market and post-market processes so that innovation can proceed so as to benefit patients while maximising the ability to act quickly if any problems materialise.

Q143 Graham Stringer: I realise this is a difficult question to answer because we are dealing with averages and very different devices. Is pre-market approval likely to get more expensive and take a longer or shorter time as you try to balance those two things? In which direction are we moving? Is it going to get more expensive and burdensome in a regulatory way, or can we do it more quickly?

Sir Kent Woods: We can certainly continue to do it quite quickly, but it is likely that for the more high-risk devices, particularly implanted ones, there will be an increased cost of doing more clinical studies pre-market authorisation, but, as I was suggesting earlier, we should not allow that to become so burdensome that it shuts off the innovation process. There are equally important-in fact more important-ways of learning more about the overall effect of devices in terms of benefit and harm from the more systematic interrogation of what happens after it goes on the market. We can learn a great deal at relatively low cost by using the information systems we have in a joined-up way, whereas, if you were to focus the effort on insisting, for instance, that there were randomised clinical trials of every device going out to the pre-market approval process, first, it would become unworkable; secondly, it would become fiendishly expensive; and, thirdly, there would not be a flow of innovative devices because it just could not be made to function.

In terms of a trade-off between a system that is expensive and one that protects patients and is optimal for patient benefit, I think the right direction to travel is to strengthen the system as it is but particularly in relation to the use of registry-type data for longer-term outcome. Of course, that ought to be part of good practice anyway. If you are studying the outcomes of a procedure, you want to know it anyway. The fact that there is a device integral to that procedure is just a special case.

Q144 Graham Stringer: The problems about authorising devices do not stop at the boundaries of the European Union. The equivalent European Union institution that deals with drugs has come to agreements with European countries on the immediate boundaries of Europe. Tell us what is happening because I do not know. Is it possible to come to agreements with the Norways, Switzerlands and Ukraines of this world so that regulation applies to more than just the EU?

Sir Kent Woods: I think there are two parts to that. One is the formal arrangements. For instance, Turkey, although not in the European Union, does have notified bodies. That is an exceptional situation and is driven by considerations of the single market. But there is a wider question about products being manufactured outside the EU and coming into the EU. How do we achieve a consistent standard of conformity? The requirement is that they have to get a CE mark and do that by the same process as if they are manufactured in the UK or anywhere else.

A deeper layer to that is that we are looking at an increasingly globalised world. We have seen very strongly on the pharmaceutical side that manufacture, research and development are global activities, and to think even in terms of the European Union as if it was a completely self-contained system is no longer appropriate. As an agency, we have been very active in the last four or five years in developing good relationships with the regulatory authorities in China, Singapore, north America and Australasia. Our international strategy is driven by two considerations. First, where are our major lines of supply starting from? Therefore, we have to be concerned about the quality of manufacture in those places. I am thinking particularly of pharmaceuticals. Secondly, globally regulators need to work together to think through these problems because they are the same problems round the world. If we are regulating globalised industries, regulators have to think globally, and that is a trend I have seen very strongly in the last few years.

Q145 Stephen Mosley: Following on from that, one thing that interested me a few weeks ago when Professor Westerby was here was that he said that NHS rationed life-saving technology in a way that many more lives are lost through that than by devices going down. Do you have any guidelines as to the acceptable failure rate? If you have a device that is going to save someone’s life but is not going to be 100% perfect over a period of time, do you have any criteria you use by which you say, "It’s better to save someone’s life now than run the risk of it going wrong in five years"? Are there any guidelines or figures on that?

Sir Kent Woods: There is a general principle that we use throughout the agency around risk-based regulation. In other words, rather than having arbitrary rules that we apply across the piece, in every case you have to consider the risks and the potential benefits of alternative approaches: this medicine against that medicine; this medicine against no medicine; a medical device against no medical device. Depending on the underlying condition in the population you are treating, that judgment has to be made every time.

It is striking that, if we look at the totality of adverse incident reports that come in every year-we get about 10,000 or 12,000 reports, which we analyse in various ways-a consistent feature is the significance of operator factors. The way devices are being used will be a determinant of the outcome in about a third, we reckon, of these adverse incidents. It raises a question as to our responsibility not just in informing the world outside about the risks and benefits of medical devices but how to use medical devices. We have put out training materials in relation to infusion pumps and a whole range of commonly used devices; we have put out information to patients who are considering breast implants and all that sort of thing. These are essentially educational activities that do not fall within our legal remit, but we think that in terms of improving health outcomes they are important for us to do, and we feel that we are quite well sighted to do it.

Q146 Stephen Mosley: We have heard some very positive comments this morning about the National Joint Registry. Aside from joints, in the other areas that you cover, we have been led to believe there is less of a formal reporting system. Do you think this leads to under-reporting of problems with implants?

Sir Kent Woods: Yes. I think under-reporting runs across all areas of regulated medical products. In many ways the National Joint Registry teaches us lessons that we can roll out to other areas. First, the component parts of a good registry are that it has strong professional leadership. This is not something that the regulator imposes on an unwilling world; this is professionally driven, as indeed the NJR has been from the outset. Secondly, you need to achieve consistently high data input and make sure that procedures and the details of devices are routinely and accurately captured. That may seem a terribly simple thing, but the whole system depends on it. Thirdly, you have to think about how the database is to be interrogated, by whom and how often.

Those are the standard questions you ask whenever you are trying to set up a registry. I personally believe that registries have huge potential. We tried, as you may know, in the 1990s to set up a breast implant registry and it failed. It had Government funding, and after a dozen years it had to be discontinued because, first, the completeness of registration was totally inadequate, and, secondly, the willingness of patients-the women concerned-to give follow-up information was far too low to allow conclusions to be drawn. That is a contrast, if you like. It was a registry that failed compared with the joint registry that succeeded. Going forward we have to learn those lessons. I think the key issue for me, certainly within the NHS, is to make sure that the data are captured at the time the procedure is done. The key to that would be to have a unique device identifier so that there is a recognised code that describes a device. That is something that is very much in the Commission’s thinking for the revision of the directives.

Earl Howe: That is very important. I would only add to what Sir Kent has said that the experience of the National Joint Registry clearly shows the benefits that registries can bring to post-market surveillance. We talked about the issue of metal-on-metal hips, and the problems in that area were first identified and acted on because of the data emerging from the National Joint Registry. Before we start to get too enthusiastic about extending registries to all implantable devices, there is a lesson to be learned from the breast implant example, but we also need to bear in mind that these registries are not cheap to maintain. The National Joint Registry costs about £3 million a year. One could compare that with the £10 million spent on the whole of the MHRA’s devices-related work. That is why I have asked Sir Bruce Keogh in his review of the regulation of cosmetic interventions to consider the pros and cons of registries for all implantable devices. I think there are a number of complex issues at play here.

Q147 Stephen Mosley: A slightly different approach might be to look at the yellow card system that is used for pharmaceutical products. Do you think that might work with implants?

Sir Kent Woods: We have done two things to make it easier to report adverse incidents related to medical devices. We have created an IT system that makes it easier for manufacturers to deliver the reports to us which they hear about, but, for patient and clinician reporting, if you go to the MHRA website, in the middle of the home page there is a button about medical device adverse incident reports. That will take you into an electronic reporting system that can be used by clinicians, patients or whoever, and will go straight into our database and be analysed. We also have electronic yellow card reporting now, too. In terms of opening up the accessibility of reporting to patients and healthcare professionals, we have done both of those, but they are still spontaneous reporting systems. They complement but do not replace the need for systematic analysis of outcomes.

Q148 Stephen Mosley: After PIP and metal-on-metal hip replacements, do you think the systems are now in place to prevent another faulty implant being used so many times after problems have been detected?

Earl Howe: On the PIP implant issue, we must always remember that we are dealing there with a clear case of fraud. It was clear from my investigation that no amount of regulation could have prevented deliberate fraud of that kind. There is no criticism of the notified body in relation to the PIP manufacturer; they did their job as far as we can see perfectly adequately, but the manufacturer was out to hoodwink everybody. Prior to that finding becoming public, the MHRA’s focus was very much on trying to find out whether there was a higher than expected rupture rate in PIP implants. There is a catalogue at the back of my report of what was done when, and there is no doubt they followed up rigorously and very conscientiously every report they got in an endeavour to get to the bottom of this. I have no criticism on that front.

In the metal-on-metal example, it is probably a good news story for the reasons that I gave earlier. In this country we were able to react very swiftly with the medical community to influence clinical practice when concerns became apparent.

Sir Kent Woods: It will inevitably be the case as you improve post-market vigilance systems that you will find that some products perform below average and some above. The way the clinical community and, if necessary, the regulator responds to that is very important, but we cannot get round the fact that the systems are there to detect the less well-performing devices and to take action accordingly. There are some really interesting lessons we can draw from PIP and metal-on-metal hips, but they are totally different ones. As you have heard from the Minister, with PIPs there is no regulatory framework that is immune to being subverted. In relation to metal-on-metal, if you have a good registration and monitoring system, you will find there are some that are outliers in the wrong direction, and the speed with which you pick that up and practice and regulation respond to that is the hallmark of the quality of the regulatory system.

Chair: Minister and Sir Kent, thank you very much for an informative session. We look forward to seeing you batting in the debate over the directive. We are confident that there is a strong body of opinion inside the UK, including from patients, that, first, we want to see more transparency; secondly, we want to see British industry succeed in this field because we have some incredibly good businesses in the UK; and, thirdly, as a corollary to that, we want a regulatory system that is not so burdensome that it squeezes them out, especially in those small, very specialist areas. At the same time, there is a very difficult balance to achieve, and we wish you well in your negotiations. Thank you for coming today.

Prepared 31st October 2012