Documents considered by the Committee on 13 March 2013 - European Scrutiny Committee Contents

8 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 28 February 2013
Previous Committee ReportsHC 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

8.1 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.

8.2 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. The Government has undertaken its own consultation on the Commission proposals and intends to produce its own analysis of their financial implications for the UK. 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 Report, agreed on 13 February 2013, which sets out the Government's response to a number of issues we raised in our earlier Report.

The Minister's letter of 28 February 2013

8.3 The Parliamentary Under-Secretary for Quality (Earl Howe) describes how the Government is seeking to address in negotiations its concerns regarding pre-market scrutiny of higher risk medical devices and the removal of an exemption for "in-house" devices.

8.4 On the former, he considers that a process of additional pre-market scrutiny would delay patient access to new technologies and increase costs for manufacturers without delivering any significant benefit for patient safety. He says that the majority of stakeholders who have responded to the Government's public consultation concur, but some have suggested ways in which the assessment of higher risk medical devices by notified bodies could be improved. Initial discussions amongst Member States at a Council working group on 21 February suggest that there is, as yet, no consensus on the need for additional pre-market scrutiny, but Ministers and officials have sought to raise the UK's concerns with their counterparts in other Member States. The Minister adds:

"This includes those who are also sceptical of the necessity of pre-market scrutiny (to build support for the Government's position) and those who support pre-market scrutiny (to understand their policy rationale, influence their thinking, and be able to anticipate acceptable compromises should the political negotiations so dictate)."

8.5 The Government has also sought to influence the European Parliament, which agreed by a slim majority in June 2012 a non-binding Resolution advocating a centralised pre-market assessment procedure for higher risk and implantable devices which goes further than the pre-market scrutiny model put forward by the Commission. The Minister notes that the European Parliament has yet to express a formal position on the draft Regulations under scrutiny but the Government has made its position clear in the course of official-level meetings with MEPs and political group advisers.

8.6 Turning to the proposed removal of an exemption for higher risk in vitro diagnostic devices produced "in-house" by health institutions, the Minister notes that the public consultation revealed "mixed support" for the Government's position to maintain the exemption. Those who supported it considered that it would save costs within the NHS and ensure the continuing availability of high risk diagnostic tests for which there are no commercial alternatives. Others, however, argued that all manufacturers, including health institutions, should be required to meet the same standards. The Minister says that the Government is analysing the responses to its consultation and will provide us with a summary before the end of March. He adds:

"However, in broad terms, the Government is assured of the high standards of high risk in house tests because the proposed regulations subject the health institutions which develop in house tests to the ISO 15189 standard. This is a comprehensive, externally assessed standard that specifies requirements for quality and competence that are particular to medical laboratories. In addition, in house laboratories will have to report problems with high risk in house IVDs to national regulators. This will help to ensure that competent authorities can quickly address any safety concerns."

8.7 The Minister notes that there has been no formal discussion of the in-house exemption amongst Member States, but that Ministers and officials have raised the issue with their counterparts. Officials have also met with MEPs to underline the public health risks associated with the removal of the in-house exemption, and the Government is encouraging clinical and third sector stakeholders to raise their concerns directly with MEPs.


8.8 We thank the Minister for his letter and look forward to receiving the summary of responses to the Government's public consultation on the draft Regulations. We understand that there is some uncertainty as to the pace of negotiations during the Irish Presidency, but ask the Minister to ensure that we are informed of any significant developments in deliberations within the Council working group and the European Parliament. Meanwhile, the draft Regulations remain under scrutiny.

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Prepared 22 March 2013