Thirty-ninth Report of Session 2012-13 - European Scrutiny Committee Contents

4   Regulation of medical devices




+ ADDs 1-5

COM(12) 542




COM(12) 541

Draft Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Draft Regulation of the European Parliament and of the Council 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 27 March 2013
Previous Committee ReportsHC 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

4.1  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.

4.2  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 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.

The Minister's letter of 27 March 2013

4.3  The Parliamentary Under-Secretary for Quality (Earl Howe) informs us of the outcome of the public consultation on the Commission proposals carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). He says that more than 100 stakeholders submitted evidence, with the majority endorsing the Government's aim of strengthening the current regulatory framework for medical devices whilst also removing or amending elements of the proposals which place disproportionate burdens on the private or public sector. He continues:

"In particular, the majority of stakeholders agree with the Government that introducing an additional layer of centralised European bureaucracy to scrutinise the safety of medical devices will delay patient access to new technologies and not strengthen patient safety. Stakeholders did not submit a lot of quantitative evidence on this point. Therefore MHRA officials continue to reach out to stakeholders bilaterally to collect evidence and assess the likely financial impact on the UK.

"There was mixed support for the Government's preference to exempt high-risk in vitro diagnostic devices, which a single health institution develops and uses (termed 'in-house tests'), from the full regulatory requirements. Some stakeholders agreed with the Government that this will mean that tests remain available where there are no commercially available alternatives. This includes, for example, tests which need to keep pace with a changing viral genome and which need to be modified to provide a diagnosis.

"Equally, some stakeholders expressed concern that in-house tests will not meet the same patient safety standards as commercial tests but recognised the need for these diagnostic tests where there were no commercial equivalents available. I am of the view that this concern should be addressed through the governance of health institutions' pathology laboratories, such as accreditation to ISO 15189."

4.4  The Minister concludes:

"The MHRA is now strengthening the Government's position by drawing on the detailed stakeholder evidence on:

  • the need for transparent stakeholder engagement throughout the regulatory system;
  • the safety information which can most usefully be made available to clinicians and the public;
  • the most appropriate risk-based classification of certain medical devices;
  • a proportionate allocation of responsibilities on economic operators along the supply chain; and

clear and precise wording in the regulations."


4.5  We thank the Minister for summarising the outcome of the public consultation on the Commission proposals and are pleased to note that evidence submitted by stakeholders is being used to inform the Government's negotiating position. We ask the Minister to inform us of any significant developments in the negotiations, 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. Meanwhile, the draft Regulations remain under scrutiny.

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Prepared 1 May 2013