Twenty-eighth Report of Session 2013-14 - European Scrutiny Committee Contents

7   Regulation of medical devices




+ ADDs 1-5

COM(12) 542




COM(12) 541

Draft Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009

Draft Regulation on in vitro diagnostic medical devices

Legal base(Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
Basis of considerationMinister's letter of 4 December 2013
Previous Committee ReportsHC 86-xxxviii (2012-13), chapter 4 (17 April 2013);

HC 86-xxxv (2012-13), chapter 8 (13 March 2013);

HC 86-xxxii (2012-13), chapter 2 (13 February 2013);

HC 86-xx (2012-13), chapter 10 (21 November 2012)

Discussion in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information requested

Background and previous scrutiny

7.1  The 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.

7.2  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 and overly bureaucratic. Second, it questions the 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. Our Twentieth Report of 21 November 2012 describes the main changes proposed by the Commission to the EU's existing regulatory framework. It is supplemented by our Thirty-second and Thirty-fifth Reports, agreed on 13 February and 13 March 2013, which set out the Government's response to a number of issues we raised in our earlier Report, and our Twenty-ninth Report of 17 April 2013, which summarised the outcome of a public consultation on the draft Regulations carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

7.3  We have broadly endorsed the Government's approach to the negotiations and asked to be informed of any significant developments, particularly with regard to the treatment of "in-house" devices and the introduction of an additional tier of pre-market scrutiny for certain high risk medical devices, as well as the issues highlighted in our earlier Reports.

The Minister's letter of 4 December 2013

7.4  The Parliamentary Under-Secretary of State for Quality (Earl Howe) provides an update on recent developments. He tells us that the European Parliament held its plenary vote on the draft Regulations on 22 October and describes some of the key amendments agreed. The first concerns pre-market scrutiny of high risk medical devices:

"the EP voted in favour of removing the Commission's proposals for additional pre-market scrutiny and replacing it with a scrutiny system of two parts. Firstly, certain high risk devices must only be assessed by 'special notified bodies'. These special notified bodies would be designated and regulated by the European Medicines Agency (EMA). Secondly, a newly formed committee of clinical experts, the Assessment Committee for Medical Devices (ACMD), would further scrutinise a subset of these devices. This scrutiny process would involve the ACMD reviewing information submitted by the manufacturer on the clinical evaluation of the device, the post-market clinical follow-up plan and any information on marketing of the device in non-EU countries. Which devices it would scrutinise would be decided on a case by case basis according to specified criteria, such as the novelty of the device and an increased rate of serious incidents in the category or group the device belongs to. However, scrutiny would not be engaged where Common Technical Specifications or harmonised standards in relation to clinical evidence and post-market clinical follow-up were in place.

"The Government position on the proposed changes by the EP remains the same as in my previous correspondence in relation to the scrutiny mechanism proposed by the Commission. We are against any form of additional pre-market scrutiny and believe that patient safety is best safeguarded through strengthening notified bodies and co-ordinating vigilance across the EU. We are concerned that the proposals dilute the responsibility for pre-market approval and will create a longer and more uncertain approval process. Additionally, we are concerned about the costs which will be associated with the system as proposed by the EP. The EMA does not currently have the resources to designate and monitor notified bodies and there would be costs associated with building and maintaining this expertise. There would also be significant costs associated with setting up and maintaining the ACMD. Therefore, the Government does not support the EP proposals for pre-market scrutiny."

7.5  The European Parliament has also proposed changes to the provisions on the re-processing of single-use devices:

"This is the process by which medical devices, which have been labelled by the manufacturer as single-use, are reprocessed, assessed as safe and resold as a 'new' device. The core of the proposal from the EP is that all medical devices would be reprocessable by default and that a central list, maintained by the Commission, would detail all devices which are unsuitable for reprocessing and so may be labelled single-use. However, changes introduced at plenary created a confused framework which seems to allow reprocessing of all single-use devices in certain circumstances. The Government is concerned that the proposals from the EP are unworkable - even before the changes were made at plenary - and we continue to support the proposal put forward by the Commission as a balanced solution to the issue."

7.6  Turning to proposed amendments to the draft Regulation on in vitro diagnostic medical devices (IVDs), the Minister reiterates the Government's position that the highest risk (Class D) IVDs, which are developed and used "in-house" by a single health institution, should be exempted from compliance with the full regulatory requirements applicable to other IVDs. He continues:

"The EP voted in favour of widening the scope of the in-house exemption to include Class D IVDs where certain requirements are met. These requirements are that no suitable CE-marked equivalent IVD is available, the health institution is accredited to ISO 15189 and the health institution provides the Commission and their competent authority with a list of IVDs being manufactured in-house. The Government is pleased that the EP recognised the need to extend the in-house exemption to cover Class D IVDs and considers their proposal to be broadly workable, subject to some minor changes."

7.7  The Minister expresses "serious concerns" about the EP's proposal to include new provisions on genetic testing which would introduce a requirement for mandatory counselling and informed consent to be given explicitly and in writing in advance of a test, adding:

"Firstly, we are concerned that they are outside the scope of the legislation which is concerned with issues relating to the placing on the market of IVDs and not their subsequent use. Secondly, the proposals are out of step with current clinical practice in the UK and do not recognise the significant differences between different types of genetic tests. We have worked closely with stakeholders such as the European Society for Human Genetics and the Foundation for Genomic and Population Health on this issue and will continue to do so as we seek to remove these provisions during negotiations."

7.8  The Minister notes that the EP voted in favour of a system of pre-market scrutiny of IVDs similar to that proposed for high risk medical devices and reiterates the Government's opposition.

7.9  Progress within the Council has been "steady" and the Minister notes that the Council is not yet ready to present an agreed position. He continues:

"The EP and Commission have been vocal about their desire to agree the Regulations before the elections for European Parliament in summer 2014. The UK remains committed to finding agreement and hopeful that, despite a challenging timetable, productive discussions between the Council and the Parliament can take place. However, whilst we wish to make quick progress we are not prepared to rush into agreeing legislation that includes provisions that will be overly burdensome on businesses or insensitive to public health policy in individual Member States. It is critical that the final agreement strikes the appropriate balance between correcting the weaknesses whilst maintaining the strengths of the current EU system."


7.10  We thank the Minister for his helpful update and look forward to receiving further progress reports on the negotiations.

7.11  We recall that in earlier correspondence with the Committee, the Minister accepted that there was an inadequate level of transparency and accountability in the existing regulatory framework for medical devices and said that the Government would take "a critical look at all aspects of transparency in the proposed Regulations to see if it can be increased further."[25] The Report of the Science and Technology Committee on the regulation of medical implants in the EU and UK[26] also highlighted the need for greater transparency and called for all clinical data used in the approval of a medical implant to be made publicly available (without revealing the identity of patients or clinical trial participants). When the Minister produces his next progress report on negotiations, we ask him to describe the changes the Government is seeking to enhance transparency and accountability and the extent to which these are reflected in any of the amendments proposed by the European Parliament. Meanwhile, the draft Regulations remain under scrutiny.

25   See letter of 3 December 2012 from the Minister to the Chair of the European Scrutiny Committee. Back

26   Fifth Report of Session 2012-13, published 1 November 2012 (HC 163): Regulation of medical implants in the EU and UKBack

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