Thirty-second Report of Session 2012-13 - European Scrutiny Committee Contents

2   Regulation of medical devices




COM(12) 542

+ ADDs 1-5




COM(12) 541

Draft Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Commission staff working documents: Impact assessments

Draft Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices

Legal base (Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
Basis of considerationMinister's letter of 3 December 2012
Previous Committee ReportHC 86-xx (2012-13), chapter 10 (21 November 2012)
Discussion in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information requested

Background and previous scrutiny

2.1  Medical devices cover a broad spectrum of products ranging from sticking plasters and dental filling material to heart valves, hip replacements and pacemakers. The rules governing their approval and circulation within the EU are set out in three Directives adopted between 1990 and 1998. The revelation in 2010 that a French manufacturer of silicone gel breast implants (Poly Implant Prosthse or PIP) had substituted industrial grade silicone for the medical grade specified by the company when it obtained a CE Mark in 2000 has highlighted shortcomings in the current regulatory framework. These include significant differences between Member States in the designation and monitoring of certification bodies ("notified bodies") and in the quality and depth of the conformity assessments performed by them, as well as a general lack of transparency and accountability.

2.2  The draft Regulations would repeal and replace the three existing Directives. The first — document (a) — applies to all types of medical devices, including implants. The second — document (b) — applies to in vitro diagnostic medical devices used to test samples derived from the human body. Both share many common provisions, with some modifications to take account of the different characteristics of the devices. The draft Regulations are extremely detailed, each containing around 100 Articles and accompanied by extensive guidance in the form of Annexes. Our Twentieth Report of 21 November 2012 describes the main changes to the EU's existing regulatory framework, which include:

  • greater clarity as to the scope of the legislation (so, for example, devices used for aesthetic rather than medical purposes are expressly within scope);
  • stronger supervision by competent national authorities (the Medical and Health products Regulatory Agency in the UK) of notified bodies to ensure they have the necessary competence and expertise to carry out conformity assessments;
  • a clearer statement of the powers of notified bodies vis--vis manufacturers so that they can undertake regular checks and unannounced factory inspections;
  • clearer obligations for economic operators who manufacture, distribute or import devices;
  • increased transparency, including the expansion of the Eudamed databank to include publicly accessible information on devices and device manufacturers;
  • improved traceability of devices;
  • stronger rules on the clinical evaluation of medical devices before approval and on market surveillance and safety reporting once the devices are in use; and
  • better management of the regulatory system at EU level.

2.3  The Government welcomed the draft Regulations, subject to two concerns. First, it considered that the Commission's proposals to introduce additional pre-market scrutiny of higher risk devices by a central Committee of Member State experts would be ineffective and overly bureaucratic. Second, it questioned the removal of an existing exemption for "in house" devices manufactured and used within the same health institution which would substantially increase costs within the NHS. The Government also indicated that it would undertake its own consultation on the Commission proposals and produce its own analysis of their financial implications for the UK.

2.4  We noted that the draft Regulations proposed significant changes to the existing EU regulatory framework for medical devices and endorsed the conclusion of the inquiry undertaken by the Science and Technology Committee that the new framework should promote greater transparency and accountability, prioritise public health and patient safety, and establish more effective channels for communication and coordination amongst and between Member States and the Commission, whilst avoiding excessive or unwarranted centralisation at EU level.

2.5  We welcomed the Government's intention to consult widely on the draft Regulations and assess their likely financial impact for the UK, and asked to be informed of the outcome of both exercises. We also looked forward to receiving details of the Government's analysis of the appropriateness of the delegated and implementing powers conferred on the Commission. Meanwhile, we sought further information on a number of matters which are set out in the response from the Parliamentary Under-Secretary for Quality (Earl Howe).

The Minister's letter of 3 December 2012

2.6  The Minister's letter reproduces (in bold) the issues we raised in our earlier Report and provides the Government's response.

Does the Government accept the arguments advanced by the Commission for using Regulations instead of Directives?

"The Government agrees that using directly applicable regulations, rather than directives, will help to ensure a consistent application of the rules across the European Union (EU), which is a weakness that we have identified in the current regulatory system. As well as helping to assure a consistent level of public health protection across Europe, it will also benefit manufacturers by removing diverging requirements between different Member States that undermine the principles of the single market.

"In addition, in light of the Government's policy of not gold-plating European directives but rather copying them out into UK law during transposition, the UK would not seek to gain any advantages if the legislation remains in the legal form of directives."

Does the Government agree that there is insufficient transparency and accountability within the current regulatory framework? If so, do the Commission's proposals go far enough, or is there scope to go further in some areas?

"The Government agrees that there is an inadequate level of transparency — and therefore accountability — in the current regulatory framework. The default assumption must be transparency which will improve patient safety and public confidence in the regulation of medical devices.

"The Commission's proposals certainly improve transparency, for example, by requiring manufacturers to publish a publicly available summary of safety and clinical performance information for their high risk devices. Notified bodies will check this before the device can be CE marked and placed on the EU market. In addition the Eudamed database — discussed further below — will be a significant step forward in providing publicly available details on the devices on the EU market.

"The Government sees this as a critical area to address in the revision of the legislation and as such is taking a critical look at all aspects of transparency in the proposed regulations to see if it can be increased further. For example, the regulations could more clearly specify the content of these summaries of safety information and manufacturers could be required to keep them up to date, taking account of the experience gained through post-market surveillance."

How much information in the Eudamed databank should be made available to the public? Where access is restricted to Member States and notified bodies, should it be extended to healthcare professionals?

"As a guiding principle, the Government supports the need for as much transparency as possible so long as personal data and legitimate commercially sensitive information is fully taken into consideration. Another issue that we need to take into account is that information must be presented in a helpful and easily digestible way for healthcare professionals and the public. This will help to ensure that the information is of added value and reduce the risk of misinterpreting the available data, which might undermine patient confidence.

"Eudamed will be comprised of six different databases with varying levels of public access. The following table provides an overview:
DatabaseInformation Public access
RegistrationAll devices and economic operators, as well as the summaries of safety and clinical performance for high risk devices Accessible to the public
Unique Device Identification UDI codesAccessible to the public
CertificatesCertificates issued by notified bodies and information on those certificates which have been refused, suspended, reinstated, restricted or withdrawn Accessible to the public
VigilanceSerious adverse incidents and field safety corrective actions and notices Accessible to the competent authorities, the Commission and notified bodies

"Appropriate levels of access" for healthcare professionals and the public

Market surveillance Measures taken by Member States as regards devices which present a risk to health and safety as well as any preventative health measures Accessible to Member States and the Commission


Registration information Accessible to the public unless for reasons of: personal data, commercially sensitive information, effective supervision of the conduct of the clinical investigation

Exchange of information between Member States and the Commission, information about multi-state investigations, reports on serious adverse events Accessible to Member States and the Commission

"The Government is currently evaluating whether or not Eudamed is sufficiently transparent, taking into account the principles outlined previously. In particular we are discussing widely — including with patient groups and healthcare professionals — what appropriate access to vigilance information would constitute and how this could be more precisely defined. We do not consider that healthcare professionals should have 'enhanced' access above and beyond that of the public."

What evidence is there to suggest that "forum shopping" by device manufacturers (to obtain approval from a less rigorous notified body) is a problem within the EU?

"Echoing Sir Kent Woods' oral evidence to the Science and Technology Committee, it is difficult to reliably detect the extent to which forum-shopping exists; 'the anecdotes have certainly circulated'. Evidence from John Howlett, Head of Notified Body at the British Standards Institute (BSI) clarified that manufacturers withdrew from conformity assessments with BSI only to gain certification through another notified body seven times over the past five years.[15]

"The Government thinks that improving the consistent quality of notified bodies across the EU is imperative to mitigate the risk of forum shopping and improve the safety of medical devices.

"The draft regulations require notified bodies to inform other notified bodies where an application by a manufacturer is withdrawn prior to their conformity assessment decision. We are currently considering whether there is a more robust way to address this issue — for example by requiring manufacturers to disclose their previous interactions with other notified bodies when they apply for a conformity assessment."

Does the Government consider that the introduction of joint assessment teams will help to iron out differences between notified bodies?

"Improving the quality of notified bodies is a key priority for the Government. The draft regulations make the rules on supervising notified bodies more robust. They also set out in much greater detail the requirements that notified bodies must meet — from the minimum level of clinical expertise to avoiding conflicts of interest. The draft regulations also introduce joint audits of notified bodies by a team of experts from different Member States and the Commission every three years, coupled with oversight by the new group of Member State experts, the Medical Device Coordination Group (MDCG). The Government considers that this will help significantly to ensure that the more stringent criteria are consistently applied across the EU and will drive a substantial improvement in all notified bodies. We are considering — and have requested views in the public consultation — whether there are further steps that can be taken in this area.

"It is a Government priority to improve the quality of notified bodies as soon as possible and not only when the new legislation applies (2017 at the absolute earliest). Following the events involving fraudulent PIP breast implants, the European Commissioner for Health and Consumers wrote to all Member States with a joint plan for immediate action. As a result of this cooperation, the UK has committed to participating in, and is pushing for an accelerated introduction of, joint audits of notified bodies on a voluntary basis. This is due to begin early in 2013.

"Moreover, as part of the joint plan for immediate action, the UK has:

  • audited the six UK notified bodies which assess high risk devices and taken action to support their assessment of clinical evidence;
  • worked with the Commission to draft an implementing regulation, which will amend the existing directives, to tighten the rules on notified bodies in advance of the agreement to the draft regulations. We expect that this implementing regulation will be agreed in early 2013; and
  • worked with the Commission on a non-binding check list of items to be verified by notified bodies during an audit of a manufacturer, which we expect to be published around January 2013."

We note that the proposal to introduce an additional tier of pre-market scrutiny at EU level for certain high risk devices by a Committee of Member State experts (the Medical Device Coordination Group — MDCG) only envisages intervention by the MDCG for a "scientifically valid health reason" and requires a summary of the Committee's views to be made available to the public. Does the Government consider that this procedure, if used sparingly, could help to increase transparency and accountability for the approval of devices likely to be of most concern to the public?

"The Government is unconvinced that this procedure, even if used sparingly, could increase transparency and accountability in a proportionate way that effectively improves patient safety. Our concern is that given the high number and wide range of class III devices going through conformity assessment in the EU (estimated by the Commission to be 3,000 per year), it would be extremely challenging for the Medical Device Coordination Group to identify the devices of most concern to the public for a scientifically valid health reason within the proposed timescales and without the relevant clinical expertise. Thus if this provision does remain in the final legislation, the Government firmly believes that it must be designed so that it is clinically-led and the range of devices going through such a procedure must be more narrowly defined.

"However, our preference is to remove this provision and focus on improving the quality of notified bodies so that the conformity assessment is rigorous and effective. We do not think that adding an additional level of centralised scrutiny will add value to the conformity assessment procedure without duplicating the notified bodies' work and delaying patients' access to life-changing medical technology."

Is the more detailed guidance on clinical evaluations contained in the draft Regulation on medical devices helpful in clarifying the circumstances in which equivalence data may be used as part of a conformity assessment and what impact is it likely to have on the time needed to bring a new device to market?

"The Government finds that the draft proposals set out much clearer rules on when it is appropriate for manufacturers to use clinical data which is sourced from studies on a similar device (termed 'equivalence'): the devices must have the same intended purpose and their technical and biological characteristics and the medical procedures must be so similar that there would not be a clinically significant difference between their safety and performance. In addition, the legislation carries forward the requirement for a manufacturer to give due justification if they do not intend to perform specific clinical investigations on a class III or an implantable device.

"The Government's view is that a manufacturer must thoroughly evaluate the relevant clinical data in order to demonstrate the safety and performance of their device — irrespective of whether equivalence data is relied upon or a clinical investigation is undertaken. Manufacturers' clinical evaluations must then be properly assessed and the use of equivalence critically appraised by notified bodies.

"It is difficult to evaluate to what extent these updated rules will mean delays for devices that may no longer be able to rely solely on equivalence data. This has not been an issue that has been raised with the Government in the extensive discussions that we have had with stakeholders, including manufacturers, on the draft regulation. Given the importance of a full clinical evaluation in assuring the safety of devices before they come to the market, we do not consider that the strengthened requirements are likely to be a disproportionate requirement."

The draft Regulations do not require Member States to make the reporting of serious incidents by healthcare professionals mandatory. Does the Government intend to do so?

"Article 61(3) of the proposed regulation on medical devices states:

'The Member States shall take all appropriate measures to encourage healthcare professionals, users and patients to report to their competent authorities suspected

serious incidents.'

"The Government is content with this requirement but would consider any action by the EU to mandate reporting of incidents by healthcare professionals to stray into the organisation and delivery of health services which remains a national competence.

"However, the Government absolutely agrees on the importance of improving the current culture of reporting by healthcare professionals in the UK. The Science and Technology Committee has recommended that the Government make the reporting of adverse incidents mandatory for healthcare professionals; the Government has given this due consideration in the past and will do so again.

"Following Earl Howe's review in May of this year into the action of the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) following the events involving fraudulent PIP breast implants,[16] the MHRA has begun a programme of work to improve reporting of adverse incidents by healthcare professionals. This includes:

  • working with the Royal Colleges and the relevant professional bodies to connect with the relevant safety committees and improve links to the MHRA's reporting web pages;
  • designing enhanced systems to join up the facilities for reporting by introducing interactive on-line reporting facilities and improving links with the National Reporting and Learning system; and
  • developing guidance for Medical Devices Liaison Officers who are responsible for encouraging and streamlining reporting by professionals to the MHRA."

What is the Government's position on the role of "EU reference laboratories"?

"EU reference laboratories may be a cost-effective way to raise standards across the EU and for notified bodies, Member States and the Commission to gain access to scientific expertise. However, we must ensure that reference laboratories will deliver tangible benefits and address a current gap in access to scientific expertise before resources and funding are devoted to setting them up. Thus the Government considers that there needs to be further consideration and discussion with other Member States, the Commission and stakeholders. The public consultation on the draft regulations will hopefully provide further evidence about how much added value they could bring."

What is the Government's view of the Commission's assessment of the operational costs of implementing the draft Regulations?

"The Government looks forward to the evidence provided during the public consultation on the draft regulations, which we hope will allow officials to make a more thorough analysis of the financial impact of the draft legislation on the UK.

"As the Government outlined in its Explanatory Memorandum, the Commission's impact assessment lacks concrete, representative data and many of its claims and assumptions, which form the basis for their policy proposals, demand further substantiation."

We also await the outcome of the Government's analysis of the appropriateness of the delegated and implementing powers conferred on the Commission.

"The Government thinks that it is important to conduct a thorough case-by-case analysis of the proposed delegated and implementing powers conferred onto the Commission, which will be an ongoing process over the coming months. We will take into account the cross-Government guidance agreed by Cabinet Office to ensure that the conferral of these powers is proportionate and respects the balance of competences between the UK and the EU."


2.7  We thank the Minister for his extremely comprehensive and helpful response and are content with the way in which the Government intends to approach negotiations on the draft Regulations. We look forward to hearing how the Government's concerns regarding pre-market scrutiny of higher risk medical devices and the removal of an exemption for "in house" devices are being addressed. We also look forward to receiving further information on the outcome of the Government's consultation on the draft Regulations and its assessment of their likely financial impact for the UK. Meanwhile, the documents remain under scrutiny.

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Prepared 25 February 2013