4 Regulation of medical devices
| (a)
(34294)
14493/12
+ ADDs 1-5
COM(12) 542
(b)
(34295)
14499/12
COM(12) 541
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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
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| Legal base | (Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
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| Department | Health |
| Basis of consideration | Minister's letter of 27 March 2013
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| Previous Committee Reports | 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)
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| Discussion in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information requested
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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."
Conclusion
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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