Not cleared from scrutiny; further information requested; drawn to the attention of the Health Committee and the Science and Technology Committee
(a) Proposal for a Regulation on medical devices
(b) Proposal for a Regulation on in vitro diagnostic medical devices
(Both) Article 114 and 168(4)(c) TFEU; ordinary legislative procedure; QMV
(a) (34294), 14493/12 + ADDs 1–5, COM(12) 542
(b) (34295), 14499/12, COM(12) 541
4.1The term “medical devices” encompasses a vast array of products used for medical purposes, ranging from sticking plasters to hip replacements and pacemakers. The 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; the second—document (b) — to in vitro diagnostic medical devices used to test samples derived from the human body. The purpose of the changes proposed is to establish “a robust, transparent and sustainable regulatory framework” which fosters the development of “safe, effective and innovative” medical devices. The Regulations seek to achieve these objectives by introducing a more rigorous system for Member State supervision of “notified bodies”—national bodies responsible for certifying that medical devices are safe for use—and by ensuring greater transparency and accountability in relation to devices and their manufacturers.
4.2Negotiations on these complex and technical proposals began in 2012. The Government broadly welcomes the proposed Regulations and its engagement with the Committee during a protracted negotiating process has been exemplary. The Government has identified two issues of particular concern. First, it considers that the Commission’s proposal to introduce an additional tier of pre-market scrutiny for 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.
4.3Our earlier Reports, listed at the end of this chapter, provide a detailed overview of the proposed 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.
4.4Our predecessors agreed to grant a scrutiny waiver in March 2015 to enable the Government to support a general approach within the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council. They did so on the basis that:
4.5Trilogue discussions involving the Council, European Parliament and Commission began last October and have continued during the Dutch Presidency. The Minister for Life Sciences (George Freeman) provided an initial progress report last December. In his latest update, he says that the Presidency has made “excellent progress” and that the UK has been able to negotiate “largely positive outcomes on all of our key priorities” although we note provisions on genetic testing have not been resolved. He expects the June EPSCO Council to “note progress made” and undertakes to write again once trilogue discussions have concluded and the final details of the negotiations are known.
4.6We thank the Minister for his update and his constructive engagement with the Committee on these complex and important proposals. We welcome the progress that has been made during the Dutch Presidency. We note that the Government has secured an acceptable outcome on its key negotiating objectives, but has not yet been able to achieve a satisfactory outcome on genetic testing. Before clearing the proposed Regulations from scrutiny, we ask the Minister to explain how this issue has been resolved and what impact (if any) it will have on clinical practice in the UK. We draw the latest developments to the attention of the Health Committee and the Science and Technology Committee.
(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), + ADDs 1–5, COM(12) 542; (b) Proposal for a Regulation on in vitro diagnostic medical devices: (34295), , COM(12) 541.
4.7In 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—and the Minister’s confirmation that the UK’s efforts in this area would be reflected in the final agreed text.
4.8The European Parliament (EP) formally agreed its First Reading position on both proposed 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 has opposed 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 has also opposed 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.
4.9The Minister confirms that the outcome negotiated on the Government’s two key concerns—pre-market scrutiny of high-risk medical devices and an exemption for “in-house” devices manufactured and used within the same health institution—is acceptable. He is also content with the positions agreed on the re-processing of single-use devices, the use of hazardous substances in medical devices and mandatory liability insurance for manufacturers. Provisions on the use of genetic testing have not yet been resolved but the Minister is “working to ensure the final agreement is in line with the UK’s priorities”.
4.10The Minister describes the latest state of play:
“We have been clear that the agreed scrutiny mechanism will only apply to a narrow range of the very highest-risk devices and diagnostics, and only truly novel ones, where a notified body may not have examined such a device before.
“In the Council text, the Commission’s proposal for a new standing European body was replaced by a pool of practising clinicians, who can be brought together in small numbers on an ad hoc basis to review specific devices. These ‘expert panels’ will also be able to translate their specific findings about the type of products they have seen into broader common specifications for use by industry and notified bodies, which will replace the need to individually review other specific devices in that category in future.
“These reviews by ‘expert panels’ will also be strictly time limited, and purely clinical in their focus, in order to limit any duplication of the work of the notified body. One of the most important aspects is that the notified body shall retain the final decision for whether to authorise the product, and can choose to disregard the opinion of the expert panel if it disagrees. Overall, we believe the latest text continues to meet the principle of clinically-led proportionate scrutiny.”
4.11The Minister explains that the latest text retains an exemption enabling hospitals to manufacture and use their own “in-house” devices without having to meet the full regulatory requirements applicable to commercial manufacturers, such as CE markings. He continues:
“This is particularly important for NHS pathology labs as per the IVD Regulation, but also for innovative medical devices in the MD Regulation. This is how the UK has interpreted the current Devices Directives, but without our lobbying to include an explicit exemption in the new Regulations, this would no longer have been legally possible.”
4.12The Minister notes that amendments proposed by the EP would have banned 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. He continues:
“We were very concerned about this proposal, which would have banned existing devices where there is no risk of the substances they contain (though potentially hazardous in other forms) having any effect on the patient or user in their current form, and which have been safely used as such for many years.
“The latest position, which is acceptable to us, is that the continued use of such substances in medical devices must be justified, as a balance of benefit and direct risk to the patient. This shall be determined by a Notified Body, informed by scientific evidence that the Commission will be bound (by this Regulation) to produce, and which will take into account any newer, alternative substances as they become available.”
4.13The EP also proposed that all manufacturers should be required to have compulsory liability insurance to ensure that victims of defective medical devices have appropriate recourse. The Minister comments:
“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 latest text means liability remains in line with the general European Product Liability Directive (PLD), which is far more appropriate and ensures patients are protected. Manufacturers must ensure they have sufficient financial coverage for their liability in the event of a defective product (as outlined in the PLD), but crucially this does not have to be in the form of third party insurance, and it only needs to be in proportion to the scale of their enterprise, and the risk of the products they manufacture.”
4.14The Minister notes that this issue has not yet been fully resolved but adds:
“The UK does not currently reprocess devices, and would not be forced to, regardless of the final agreement on this issue.”
4.15The Minister outlines the next steps:
“If trilogue negotiations are concluded successfully in the coming weeks, we are expecting the legislation to be formally adopted and enter into force towards the end of 2016 or early 2017. The Regulations on Medical Devices and IVD devices would then fully apply from three and five years later respectively, following periods of transition.
“I will write again once the final details of the negotiations are known with a view to lifting scrutiny in the Commons before the Council’s formal First Reading position, which is expected to be taken in the autumn.
“Finally, we are looking ahead to the implementation of the new Regulations, which must be completed during the transition periods. It is important that stakeholders are engaged in this planning process, and we have already had initial discussions with many of them, and received positive feedback on our plans for implementation.
“My officials continue to engage closely with yours, and other key stakeholders, as we look forward to finalising and implementing the new Regulations.”
Sixteenth Report HC 342-xv (2015–16), (6 January 2016); Third Report HC 342-iii (2015–16), (9 September 2015); Thirty-sixth report HC 219-xxxv (2014–15), (11 March 2015); Thirty-second Report HC 219-xxxi (2014–15), (4 February 2015); Twenty-second Report HC 219-xxi (2014–15), (26 November 2014); Sixteenth Report HC 219-xvi (2014–15), (29 October 2014); First Report HC 219-i (2014–15), (4 June 2014); Twenty-eighth Report HC 83-xxv (2013–14), (18 December 2013); Thirty-ninth Report HC 86-xxxviii (2012–13), (17 April 2013); Thirty-fifth Report HC 86-xxxv (2012–13), (13 March 2013); Thirty-second Report HC 86-xxxii (2012–13), (13 February 2013); Twentieth Report HC 86–xx (2012–13), (21 November 2012).
45 See p.3 of the accompanying the proposals.
46 Fifth Report of Session 2012–13, .
47 of the European Parliament’s First Reading position.
48 The main changes proposed by the EP are described in our Twenty-eighth Report of Session 2013–14.
49 A CE marking shows that a manufacturer has checked that the product or device being marketed meets EU health, safety or environmental requirements.
1 June 2016