Documents considered by the Committee on 9 September 2015 - European Scrutiny Contents

13 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; co-decision; 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

13.1 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.

13.2 The Government broadly welcomes the proposed Regulations, subject to two principal concerns. 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.

13.3 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.

13.4 Our predecessors agreed in March to grant a scrutiny waiver 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.

13.5 In his latest letter dated 5 September, the Minister for Life Sciences (George Freeman) explains that the EPSCO Council was able to reach agreement on a partial general approach covering the substance of the proposed Regulations. He expects discussions on a number of small outstanding technical issues, as well as the recitals to the proposals, to be agreed later this month so that trilogue negotiations with the European Parliament can begin in October and a final agreement reached by the end of the year or early in 2016.

13.6 We welcome the update provided by the Minister and the progress made within the Council towards securing an agreement on these important and complex proposals. We ask him to provide a further update once trilogue discussions with the European Parliament near their conclusion and the shape and content of the final legislation is clearer, highlighting any significant changes to the compromise text agreed by the Council in June. 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. 1223/2009: (34294), 14493/12 + ADDs 1-5, COM(12) 542; and (b) Proposal for a Regulation on in vitro diagnostic medical devices: (34295), 14499/12, COM(12) 541.


13.7 In our earlier Reports, we indicated that we were content with the way in which the Government intended to approach negotiations. We shared the Government's 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[ 88] — and the Minister's confirmation that the UK's efforts in this area would be reflected in the final agreed text.

13.8 The European Parliament (EP) formally agreed its First Reading position on both proposed Regulations in April 2014.[ 89] 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.[ 90]

The Minister's letter of 3 September 2015

13.9 In his latest update, the Minister confirms that the June EPSCO Council achieved "almost unanimous political agreement" on a partial general approach covering the main substantive provisions of both of the proposed Regulations, adding:

    "This important milestone in negotiations means we remain on course to publish the new Regulations in the first half of 2016."

13.10 The Minister explains that the agreement fell short of a full general approach as the recitals to the proposed Regulations were not discussed and a number of small technical issues remain to be resolved. He nevertheless considers that the texts produced by the Latvian Presidency as the basis for the agreement in June were of a high standard, "balancing many different priorities of Member States, through thoughtful and often delicate compromises". He continues:

    "[The Presidency] were rightly commended for their efforts on this large and complex file. Although the texts were not perfect from the perspective of any one Member State, including the UK, it was widely acknowledged that to unpick a single compromise at this late stage would lead to others unravelling."

13.11 The agreement reached in June establishes the Council's mandate for informal trilogue negotiations with the European Parliament which will be taken forward during the Luxembourg Presidency. The Minister expects the recitals and remaining technical issues to be resolved within Coreper, "without reopening the key political compromises in the texts".

13.12 Turning to the substance of the agreement reached within the Council, the Minister explains that the UK was able to support all of the compromises proposed by the Presidency, including on the key issue of pre-market scrutiny of certain medical devices. He continues:

    "As a result of our leadership of a coalition of like-minded Member States, the compromise on pre-market scrutiny agreed in Council is consistent with what I have explained in previous letters; it is clinically focussed and applicable to only a narrowly defined range of products. Specifically, expert panels of clinicians will be established across the EU to provide important guidance on clinical evaluations and common specifications for novel, high-risk medical devices. As part of the compromise, they will also have a role in selecting from novel, Class III implantable devices only for additional clinical checks during conformity assessment by a notified body, but before that device is placed on the market. Importantly, manufacturers will also have the opportunity to consult these panels earlier in the development process, to help smooth final approval. Crucially, the notified body will be informed of the finding of an expert panel, but will retain the final decision as to whether or not they will market the device; though they will be asked to justify any deviation from the recommendations of the expert panel. This is vital to ensure that responsibility and the final decision continues to rest with notified bodies, and not Member States."[ 91]

13.13 The Minister describes the outcome agreed on in vitro devices manufactured "in house" as "positive, although not perfect from a UK perspective". He explains:

    "There will be an exemption from all but the essential performance and safety requirements of the Regulations for the manufacture of all devices, as long as they are manufactured and used within the same 'health institution'; a helpfully broad term. Health institutions must give due consideration to whether a commercially viable alternative is available, and must publically justify what they are manufacturing in-house on an annual basis. For Class C and D IVDs, health institutions must draw up slightly more detailed documentation. Although these provisions are additional burdens, we judged they are [a] fair compromise to make, in order to retain the exemption that the Commission proposed to remove entirely. Moreover I should note that there is an opportunity in the Trilogue process, starting in autumn, to work through and improve further the practical detail and interpretation of the text with regard to the UK's negotiating objectives."

13.14 The Minister notes that he is writing to the Devolved Administrations to update them on the outcome of the June EPSCO Council. He expects all of the outstanding technical issues to be resolved in September so that trilogue discussions with the EP can begin in October, with a view to securing a final deal before the end of the year or at an early stage in the Dutch Presidency (from January 2016). Provided the legislation is agreed by mid-2016, the Regulation on medical devices would enter into force in 2019, and the Regulation on in vitro devices in 2021.

13.15 The Minister explains that the compromise agreed by the Council in June limits the scope for the UK to influence the final legislation, but says that the Government will continue to "engage directly with the European Parliament, and be active in agreeing specific Council positions for trilogues". He undertakes to inform us of the progress of negotiations with a view to securing scrutiny clearance before the final texts of the Regulations are agreed by the Council and European Parliament.

Previous Committee Reports

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).

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

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

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

91   Details of implantable devices which are categorised as Class III devices are contained in the Annexes to the proposed Regulations. Back

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Prepared 23 September 2015