Documents considered by the Committee on 6 January 2016 - European Scrutiny Contents

6   Regulation of medical devices

Committee's assessment Politically important
Committee's decisionNot cleared from scrutiny; further information requested; drawn to the attention of the Health Committee and the Science and Technology Committee
Document details(a) Proposal for a Regulation on medical devices

(b) Proposal for a Regulation on in vitro diagnostic medical devices

Legal base(Both) Articles 114 and 168(4)(c) TFEU; ordinary legislative procedure; QMV
Document Numbers(a) (34294), 14493/12 + ADDs 1-5, COM(12) 542

(b) (34295), 14499/12, COM(12) 541

Summary and Committee's conclusions

6.1  These proposed Regulations would repeal and replace three existing Directives which establish the EU regulatory framework for medical devices. The first — document (a) — applies to all types of medical devices, ranging from sticking plasters to hip replacements and pacemakers. The second — document (b) — applies to in vitro diagnostic medical devices used to test samples derived from the human body. Both seek to introduce a more rigorous system for Member State supervision of "notified bodies" — national bodies responsible for certifying that medical devices are safe for use — and to ensure greater transparency and accountability in relation to devices and their manufacturers.

6.2  The Government broadly welcomes the proposed Regulations, but has identified two issues of particular concern. First, it considers 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, overly bureaucratic and delay patient access to life-changing medical technologies. Second, it questions the proposed 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.

6.3  Our earlier Reports, listed at the end of this chapter, provide a detailed overview of these important and complex proposals, the Government's position, the outcome of a public consultation undertaken by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and the First Reading amendments agreed by the European Parliament in April 2014.

6.4  Our predecessors agreed to grant a scrutiny waiver last March to enable the Government to support a general approach at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council in June. They did so on the basis that:

·  there was broad agreement in Council on the need for an exemption for "in house" in vitro diagnostic medical devices, with discussions focussing on ensuring that such devices met minimum safety standards; and

·  the Government had set out clearly the terms on which it would be willing to support a compromise on pre-market scrutiny for higher risk medical devices, with a view to securing an outcome which was "clinically focussed", applicable to a narrowly defined range of products, and which would not undermine the wider objective of improving the quality of all notified bodies.

6.5  In September, the Minister for Life Sciences (George Freeman) wrote to inform us that the EPSCO Council had agreed a partial general approach, covering the substance of the proposed Regulations, and that he expected a number of small outstanding technical issues, as well as the recitals to the proposals, to be agreed later that month so that trilogue negotiations with the European Parliament could begin in October. His latest letter provides a further update on the progress of negotiations.

6.6  We are grateful for the Minister's constructive engagement with the Committee on these complex and important legislative proposals. We note the Minister's cautious optimism that a satisfactory compromise is within reach on pre-market scrutiny of higher risk medical devices. We look forward to receiving further details on this, and on the other outstanding issues described in his letter, once the shape and content of the final compromise package is clearer. We will, at that stage, consider lifting our scrutiny reserve. We draw the latest developments to the attention of the Health Committee and the Science and Technology Committee.

Full details of the documents: (a) Proposal for a Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009: (34294), 14493/12 + ADDs 1-5, COM(12) 542; (b) Proposal for a Regulation on in vitro diagnostic medical devices: (34295), 14499/12, COM(12) 541.


6.7  In our earlier Reports, we indicated that we were content with the way in which the Government intended to approach negotiations. We shared its concern that the introduction of additional pre-market scrutiny of higher risk medical devices might delay patient access to new technologies and increase costs for manufacturers without delivering any significant benefits for patient safety. We noted that the Government's consultation of stakeholders revealed mixed views on the need to maintain an existing exemption for high risk in vitro diagnostic devices developed and used within a single health institution (so-called 'in-house' tests). We asked the Government to inform us of any significant developments in the negotiations, particularly on these two issues, and to indicate what type of compromise the Government would be willing to accept to address shortcomings in the current regulatory system without introducing a further layer of pre-market scrutiny. We also welcomed the Government's efforts to increase transparency — a key concern raised by the Science and Technology Committee in its Report, Regulation of medical implants in the EU and the UK[53] — and the Minister's confirmation that the UK's efforts in this area would be reflected in the final agreed text.

6.8  The European Parliament (EP) formally agreed its First Reading position on both proposed Regulations in April 2014.[54] The EP proposed that certain high risk medical devices should be assessed by "special notified bodies" designated by the European Medicines Agency and that there should be a further tier of scrutiny, applicable on a case-by-case basis, to be carried out by an expert Assessment Committee for Medical Devices. The Government opposes these changes on the grounds that they may dilute responsibility for pre-market approval, create a longer and more uncertain approval process, and increase costs. It also opposes the EP's proposal to include new provisions on genetic testing, counselling and informed consent in the draft Regulation on in vitro diagnostic medical devices.[55]

6.9  When we considered the proposed Regulations last September, we welcomed the progress made within the Council towards securing an agreement and requested a further update once trilogue discussions with the European Parliament — expected to start last October — were nearing their conclusion and the shape and content of the final legislation was clearer. We asked the Minister to highlight any significant changes to the general approach agreed by the Council.

The Minister's letter of 18 December 2015

6.10  The Minister summarises the progress made so far within the Council:

"In June 2015, the Latvian Presidency reached Council agreement on a 'Partial General Approach' for both Regulations. This important political milestone allowed the Luxembourgish Presidency to resolve outstanding 'technical' and 'drafting' issues with the Council texts over the summer, which included work on the Recitals. At the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 5 October, Council finalised its full 'General Approach'[56]. This provided the basis to start informal trilogue negotiations with the European Parliament and Commission. The Parliament's position was adopted in April 2014 through its proposed amendments to the Commission's proposal."

6.11  The Minister explains that "a series of technical and political trilogues with the Parliament and Commission" were scheduled to run from October to December 2015, with negotiations on both of the proposed Regulations divided into four 'blocks' (summarised in an Annex to this chapter). The December EPSCO Council recognised that it would not be possible to secure a full agreement before the end of the Luxembourgish Presidency, given the highly technical nature of the proposals. He adds:

"Trilogue negotiations will therefore continue in 2016, and there is a collective will to reach a final agreement under the Dutch Presidency, whose forward planning and expertise in medical devices will prove important in securing sensible compromises with the Parliament and Commission."

6.12  Despite the lack of an overall agreement, the Minister notes that "relatively fixed agreements" have been reached on several important aspects of the proposed Regulations concerning their scope, the obligations on economic operators, and the identification and traceability of medical devices, but that nothing can be considered as final until "every aspect of the texts has been discussed and agreed". He continues:

"From the perspective of the UK, the most important agreement reached so far is our success in retaining an exemption for hospitals to manufacture and use their own devices 'in-house', without needing to meet the same regulatory requirements as a commercial manufacturer; this is particularly important for NHS pathology labs. As a result of engagement with MEPs, the agreement reached is actually an improvement on the Council text, as it narrows the scope of particular requirements to the highest class of IVDs [in vitro devices] only; the Council text required this for both Class C and Class D IVDs.

"The other key UK priority for negotiations, pre-market scrutiny, has only been discussed in a preliminary way, but we remain optimistic of finding an appropriate compromise."

6.13  The Minister comments on the remaining issues — the re-processing of single-use devices, genetic testing, the use of hazardous substances and mandatory liability insurance for manufacturers — on which a compromise has yet to be agreed:

"Re-processing is not a key concern for the UK, which currently advises against such practice but has not banned it. The Council text would allow Member States the choice of whether to allow re-processing on their territory or not. However, this has become a key point of contention for others and needs to be considered carefully during negotiations.

"The European Parliament has proposed amendments that would severely hamper the use of all types of genetic testing across the EU. There is significant opposition in Council and among stakeholders for this proposal, which would mean all genetic tests could only be conducted with the approval of a qualified medical professional, and only once full consent had been provided, informed by 'appropriate genetic counselling' — again involving a medical professional — for any predictive or diagnostic test involving genetic material. This would be highly inappropriate for a broad range of tests that utilise some form of genetic material.

"The European Parliament has also proposed amendments that would ban medical devices containing any trace of substances that can be considered carcinogenic, mutagenic or toxic to reproduction (CMRs) or have endocrine-disrupting properties in any form. We are concerned about this proposal, which would also affect devices where there is no risk of such materials having any effect on the patient or user in their particular form, and which have been safely used as such for many years. We hope to find a compromise that will maintain patients' access while allowing for such substances to be phased out in favour of newer and safer alternatives as they become available.

"In an effort to guarantee appropriate recourse for victims of defective medical devices, the Parliament has called for compulsory liability insurance for all manufacturers. The problem with this is practical, in that insurance companies may not want to offer this protection in all cases. Even if available, the premiums would be very expensive and potentially unaffordable for SMEs. The core of the Parliament's concern is long-term implants, where problems may emerge years after a manufacturer has ceased to trade and cannot be held to account. However, in such a case the defunct manufacturer would have also ceased paying insurance premiums. We are not aware of an insurer that would offer an ongoing coverage following the cessation of premium payments, and if they did it would have to be prohibitively expensive to cover the ongoing risk. Again, we are working to find an acceptable solution."

6.14  The Minister expects trilogue negotiations to continue during the Dutch Presidency (beginning in January 2016) "with a view to securing informal agreement to all key issues with the Commission and European Parliament" by the end of the Presidency in June. At that stage, he expects the Council formally to adopt its First Reading position which the European Parliament would agree to at its Second Reading. On this timetable, the Regulations could be formally adopted and enter into force around autumn 2016, with a deadline for implementation in the UK of 2019 for the Regulation on medical devices and 2021 for the Regulation on in vitro medical devices. The Minister adds:

"We have offered our full support to the Dutch Presidency, and will work with them to secure appropriate compromises with the Parliament and Commission. We also continue to engage closely with key stakeholders, particularly industry, as we look forward to implementation of the new Regulations.

"It is important that stakeholders are engaged in this planning process, and we have already had initial discussions with many of them, with a view to producing a detailed implementation plan, although it cannot be finalised until the requirements of the Regulations are agreed and the timescale is clear. My officials continue to engage closely with yours, and other key stakeholders, as we look forward to finalising and implementing the new Regulations."

6.15  The Minister sets out the next steps for Parliamentary scrutiny of the proposed Regulations:

"Around Spring 2016, when we expect the content of the final compromise package to become clearer, I expect to write again to seek a scrutiny waiver, which would allow us to vote on the final Council position in line with the conditions specified in that waiver. My officials have agreed with the Committee Clerk that this will be necessary because there is unlikely to be time to present the final compromise to the Committee for a decision before we would be asked to vote on it in Council. Following a vote, I would then write again to set out the final details of the Council First Reading Position, and ask the Committee to formally lift scrutiny, which would be based on our having voted on a package within the conditions set out in any such waiver and being a positive outcome for the UK."

Previous Committee Reports

Third Report HC 342-iii (2015-16), chapter 13 (9 September 2015); Thirty-sixth report HC 219-xxxv (2014-15), chapter 7 (11 March 2015); Thirty-second Report HC 219-xxxi (2014-15), chapter 4 (4 February 2015); Twenty-second Report HC 219-xxi (2014-15), chapter 4 (26 November 2014); Sixteenth Report HC 219-xvi (2014-15), chapter 2 (29 October 2014); First Report HC 219-i (2014-15), chapter 7 (4 June 2014); Twenty-eighth Report HC 83-xxv (2013-14), chapter 7 (18 December 2013); Thirty-ninth Report HC 86-xxxviii (2012-13), chapter 4 (17 April 2013); Thirty-fifth Report HC 86-xxxv (2012-13), chapter 8 (13 March 2013); Thirty-second Report HC 86-xxxii (2012-13), chapter 2 (13 February 2013); Twentieth Report HC 86-xx (2012-13), chapter 10 (21 November 2012).

53   Fifth Report of Session 2012-13, HC 163. Back

54   Summary of the European Parliament's First Reading position. Back

55   The main changes proposed by the EP are described in our Twenty-eighth Report of Session 2013-14. Back

56   See the text of the Council General Approach. Back

previous page contents next page

© Parliamentary copyright 2016
Prepared 15 January 2016