Documents considered by the Committee on 29 October 2014 - European Scrutiny Committee Contents

2 Regulation of medical devices

Committee's assessment Politically important
Committee's decisionNot cleared from scrutiny; further information requested; drawn to the attention of 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

2.1 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.

2.2 The Government broadly welcomes the draft Regulations, subject to two 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.

2.3 Our earlier Reports provide a detailed overview of the draft Regulations, the Government's position on the main changes proposed by the Commission to the current EU regulatory framework, 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. When we lasted considered the draft Regulations, in May 2014, the Parliamentary Under-Secretary of State for Quality (Earl Howe) told us that relatively little progress had been made during the Greek Presidency, but that he expected the Italian Presidency to "take a firm grip on negotiations and steer Council towards a political agreement between Member States" at the end of 2014. He also identified a number of areas in which the Government had proposed further changes to enhance transparency and accountability within the proposed new regulatory framework.

2.4 The Minister now informs us that the Italian Presidency intends to seek a common position on a Presidency compromise text before the end of the year. He describes the progress made in Council and invites us to lift our scrutiny reserve so that the Government is in a position to support a compromise text, provided it meets the Government's key negotiating objectives.

2.5 The draft Regulations propose significant changes to the existing EU regulatory framework for medical devices. Whilst a satisfactory outcome appears to be within reach on the Government's key negotiating objectives, we are unwilling to clear the draft Regulations from scrutiny at this stage. As the Minister observes, there remain a number of "tricky unresolved issues where there are differing views amongst Member States". It seems likely that the UK will be required to reach a compromise on one of its key negotiating objectives — the removal of provisions introducing an additional tier of pre-market scrutiny at EU level for certain high risk medical devices. We are grateful to the Minister for clarifying that, if such provisions are to remain, they must be amended to ensure that any form of pre-market scrutiny is clinically-led and only applies to a narrowly defined range of devices. We welcome his assurance that changes of this nature are "achievable" but consider that, in the absence of a Presidency compromise reflecting such an outcome, scrutiny clearance would be premature.

2.6 When further information is available on the content of a possible Presidency compromise text, we will be willing to consider granting a scrutiny waiver. Meanwhile, to assist with the process of scrutiny, we ask the Minister to clarify whether the Council common position referred to in his letter is a formal common position within the meaning of Article 294 of the Treaty on the Functioning of the European Union (TFEU) or whether, as parts of his letter imply, it is an informal agreement establishing the basis on which the Council Presidency will enter into trialogue discussions with the Commission and European Parliament. If the latter, we also ask the Minister to explain when this informal mandate for trialogue discussions will be discussed and agreed by the Council. Meanwhile, the draft Regulations remain under scrutiny. We draw the latest developments to the attention of the Science and Technology Committee.

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.


2.7 When we first considered the draft Regulations, in November 2012, we noted that the Science and Technology Committee had examined the existing regulatory framework for medical implants in the EU and the UK and recommended a number of improvements which sought to 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.[11] With these objectives in mind, we sought further information from the Government on a number of issues, notably:

·  whether it accepted that there was a need for greater transparency and accountability in any new regulatory framework;

·  whether there was evidence to suggest that 'forum shopping' by device manufacturers (to obtain approval from a less rigorous notified body) was a problem within the EU;

·  whether the introduction of joint assessment teams and/or a new tier of pre-market scrutiny for certain high risk medical devices would help to iron out differences between notified bodies and increase transparency in the approval process;

·  whether more detailed guidance on clinical evaluations of medical devices would be helpful; and

·  whether the reporting of serious incidents by healthcare professionals should be made mandatory.

2.8 The Government's comprehensive and helpful response was reproduced in our Thirty-second Report of Session 2012-13. 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 and asked whether the changes it had proposed were likely to be accepted by the Commission and other Member States.

The Minister's letter of 24 October 2014

2.9 The Minister for Life Sciences (George Freeman) informs us that, as expected, the pace of negotiations has accelerated under the Italian Presidency. He continues:

    "With no other health legislation currently being pursued by Council and a substantial team in place, the Italians are aiming to reach a common position in Council by the end of the year.

    "Whether they will be able to do so will depend on their ability to steer Council through a number of tricky, unresolved issues where there are differing views amongst Member States."

2.10 The principal unresolved issue concerns pre-market scrutiny for higher risk medical devices. The Minister indicates that amendments proposed by the UK to improve the quality of pre-market clinical evidence, place greater controls on the use of approved devices and ensure greater transparency in the pre-market process, have been well-received, with a majority of Member States sharing the UK's opposition to the introduction of additional measures over and above the pre-market checks required to be undertaken by notified bodies.

2.11 The Minister adds that it will be necessary to seek a compromise on pre-market scrutiny as the Commission and a small number of Member States (sufficient to form a blocking minority) continue to support additional pre-market measures. The Government will seek to ensure that any additional pre-market scrutiny is "clinically focused and applicable to a narrowly defined range of products". He continues:

    "Key points that we want to avoid in a compromise are a substantial duplication of a notified body's own pre-market assessment and any shift of decision-making away from notified bodies to Member States. We believe that the split of Member States means that this aim is achievable and we continue to work very closely with like-minded Member States as negotiations progress. At this stage there is not any text from the Presidency reflecting the current state of the debate, but I or my officials would be happy to share further details of the various proposals and positions of other Member States in confidence."

2.12 Turning to the proposed exemption for "in house" in vitro diagnostic medical devices ("IVDs"), the Minister describes Member States' positions as "positive", noting "a clear acceptance that all classes of IVDs should be covered by the exemption". He adds:

    "The discussion now on this issue is in relation to the conditions that should be attached to the exemption; we are working closely with NHS organisations to ensure that the minimum standards set out — such as accreditation to international standards — are sensible and proportionate."

2.13 The Minister expects the European Parliament to take a keen interest in the issue of transparency. He reports "broad agreement amongst Member States about the importance of making timely, useful information available to clinicians and the public", and adds:

    "I am therefore confident that the UK's initiatives in this area will be reflected in the final text."

2.14 Following the May 2014 elections to the European Parliament, the rapporteur (Peter Liese) for the draft Regulation on in vitro diagnostic medical devices remains unchanged. A new rapporteur — Glenis Willmott, a UK MEP in the Socialists and Democrats group — has been appointed for the draft Regulation on medical devices. As the European Parliament adopted its First Reading position on the draft Regulations in April, Both rapporteurs are expected to be keen to enter trialogue discussions with the Council and Commission soon.

2.15 The Minister sets out what he considers to be the "next steps" in securing a political agreement on the draft Regulations:

    "Whilst there remain a number of issues still to work through, we are nonetheless making progress in Council, largely through the sheer number of Working Party meetings. To meet the Presidency's aim of reaching a common position in Council by the end of the year they intend to start taking specific issues to Coreper in November for discussion and decision if necessary. We do not consider it likely that there will be any separation of negotiations on the two Regulations to speed progress; the interdependencies between the two mean such an approach would only generate more work.

    "Such a common position would not constitute a formal adoption of a first reading position by Council, which would allow us to enter trilogues immediately under the Latvian Presidency. Whilst the intention is for the common position to cover the entire text of both Regulations, it is possible that some of the technical detail in annexes that is of little interest to the Parliament could be agreed in Council alongside trilogues in order to speed progress.

    "The ultimate aim of this is to achieve an early second reading deal, whereby the Council's first reading position adopted after trilogues could be accepted by the Parliament without any changes. It is possible that the Italians may not tie up a common position by the end of the year, but either way there is a will to conclude negotiations under the Latvians. If this does not succeed then we would likely enter a formal second reading process which would in all probability take us into 2016 before any agreement can be concluded."

2.16 The Minister notes that discussions will be starting shortly at Council and Coreper level to reach agreement on a compromise text and expects progress to be rapid. He therefore invites us to:

    "lift scrutiny on the basis that any agreed common position in Council falls within the parameters that I have outlined in this letter for our key negotiating objectives. Should this not be the case then I will urgently write to your Committee again with an update and to seek further clearance."

Previous Committee Reports

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).

11   Fifth Report from the Science and Technology Committee, (2012-13), Regulation of medical implants in the EU and the UK, HC 163. Back

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Prepared 7 November 2014