Documents considered by the Committee on 4 February 2015 - European Scrutiny Contents

4 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) Draft Regulation on medical devices; (b) Draft 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

4.1 These draft 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, including implants. 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" — 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.

4.2 The Government broadly welcomes the draft 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.

4.3 Our earlier Reports, listed at the end of this chapter, provide a detailed overview of these important and complex draft Regulations, 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.

4.4 When we last considered the draft Regulations, at our meeting on 26 November 2014, we agreed to grant a scrutiny waiver to enable the Government to support a possible general approach at the December 2014 Health Council. If agreed, this would provide a mandate for the Council to start informal "trilogue" discussions with the European Parliament and the Commission. In granting a waiver, we noted 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 meet minimum safety standards. We considered that 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 and expressed support for its efforts to secure an outcome which was "clinically focussed", applicable to a narrowly defined range of products, and did not undermine the wider objective of improving the quality of all notified bodies.

4.5 In his latest letter, the Minister for Life Sciences (George Freeman) explains that the Italian Presidency was unable to secure a general approach at the December 2014 Health Council and sets out the next steps in the negotiating process.

4.6 We are grateful for the Minister's update. The draft Regulations remain under scrutiny and the Government will need to request a further scrutiny waiver or clearance if the Latvian Presidency seeks to achieve a general approach within the Council, or a political agreement with the European Parliament, before the end of its term in June. As negotiations appear to be entering an important phase, we draw the latest developments to the attention of the Health Committee and the Science and Technology Committee. Meanwhile, we look forward to receiving regular progress reports on negotiations within the Council and on any informal trilogue discussions with the European Parliament.

Full details of the documents: (a) Draft 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) Draft Regulation on in vitro diagnostic medical devices: (34295), 14499/12, COM(12) 541.


4.7 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[19] — and the Minister's confirmation that the UK's efforts in this area would be reflected in the final agreed text.

4.8 The European Parliament (EP) formally agreed its First Reading position on both draft Regulations in April 2014. 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.[20]

The Minister's letter of 27 January 2015

4.9 The Minister (George Freeman) expresses his gratitude for the specific scrutiny waiver we granted last November, ensuring that "any last-minute negotiations on […] a 'general approach' at the Health Council would have been aligned with UK negotiating priorities, which have previously been established with your Committee".

4.10 He confirms that, in light of concerns expressed by some Member States, the Italian Presidency decided not to seek agreement to a general approach, but instead gave a short progress report accompanied by a brief exchange of views on a few key issues. He adds that there are "no relevant updates to report on the UK's key negotiating objectives at this stage".

4.11 Turning to the timetable envisaged by the Latvian Presidency, the Minister indicates that there is the prospect either of a political agreement or a general approach on the draft Regulations at the Health Council on 19 June. He continues:

    "The Presidency's ideal goal would be to achieve a political agreement following informal trilogues between the European Commission, European Parliament and the Council. This would constitute Council's formal first reading position and — assuming agreement with the Parliament was achieved during trilogues — would then allow this text to be adopted by the Parliament in their second reading position.

    "Achieving a 'general approach' at Health Council is perhaps more realistic. In this outcome, the Council would not be adopting a formal first reading position. Instead the 'general approach' would form the basis for the Council's position in informal trilogues to begin under the incoming Luxembourg Presidency in the second half of 2015."

4.12 The Minister undertakes to inform us of any informal trilogue negotiations and to provide any further details we require on the substance or progress of negotiations. He adds:

    "More generally, I would like to take this opportunity to reassure you that I take the issue of ensuring rapid access to innovative therapies very seriously, which is why I have launched a major review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology. This review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices, including cancer treatments and diagnostics. It will set out both short and long-term options for action by Government and relevant bodies, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency and NHS England, and mark a major contribution to the policy debate."

4.13 During his visit to Brussels at the end of February, the Minister reiterates his intention to "highlight the need for Europe to embrace innovative medical technologies and to ensure that regulations in this sphere are fit for purpose".

Previous Committee Reports

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).

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

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

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Prepared 13 February 2015