The Committee on the Environment, Public Health and
Food Safety adopted the recommendation for second reading contained
in the report by Peter LIESE (EPP, DE) on the Council position at
first reading with a view to the adoption of a regulation of the
European Parliament and of the Council on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and Commission
Decision 2010/227/EU.
The committee recommended the European Parliament to
approve the Council position at first reading without
amendments. It also took note of two Commission statements
annexed to the draft legislative resolution.
The Commission:
- undertakes to present, no later than five years after
the date of application of the Regulation, a report on Member
States experience with the implementation of the
obligations concerning the provision of information and counselling
in the context of genetic testing;
- specifies that genetic testing intended for
wellbeing or lifestyle purposes is not covered by the
definitions in the Regulation. Nevertheless, the Commission will
monitor specific safety issues which might be linked to the use of
these devices.
Councils first reading position is in conformity
with the agreement reached during the interinstitutional
negotiations. The report is accompanied by a short justification
which focuses on the following elements of the approved
text:
- obligation for notified bodies to carry out
unannounced inspections on the production site;
- strengthening of the provisions on the designation,
organisation, monitoring and expertise of the notified bodies
conducting the conformity assessment and certification for all
devices on the Union market. These bodies shall have permanent
availability of sufficient administrative, technical and scientific
personnel of notified bodies for them to successfully conduct their
conformity assessment activities;
- obligation to submit extra conformity checks on
class D devices from a European reference
laboratory;
- obligation of the manufacturer to put in place
measures to provide sufficient financial coverage in respect
of their potential liability concerning defective
devices;
- inclusion of clear provisions on informed consent,
ethics committees, incapacitated subjects, minors, pregnant women,
transparency as regards clinical trials of medical
devices;
- individuals being tested with a genetic test should be
provided with all relevant information on the nature, the
significance and the implications of the genetic test, including
appropriate access to counselling in the case where the test
provides information on the genetic predisposition for medical
conditions and/or diseases which are generally considered to be
untreatable;
- strengthening the authorisation procedures and the
overall system for traceability of devices, vigilance and
post-market surveillance, to ensure constant monitoring and swift
reaction should problems arise.