The Committee on the Environment, Public Health and
Food Safety adopted the recommendation for second reading contained
in the report by Glenis WILLMOTT (S&D, UK) 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 medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002
and Regulation (EC) No 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC.
The committee recommended the European Parliament to
approve, without amendment, the Council position at first
reading.
Council’s first reading position is in
conformity with the agreement reached during the
interinstitutional negotiations. The report is accompanied by a
short justification which highlights the following elements of the
approved text:
- the introduction of a special procedure
involving an independent assessment carried out by a special expert
panel of the highest risk devices of class III implantable and
class IIb active devices administering or removing a medicinal
product;
- the obligation for the manufacturer to put in place
measures to provide sufficient financial coverage in respect
of their potential liability regarding defective
devices;
- strengthening the initial proposal which encourages
manufacturers to seek substitution of substances that are
carcinogenic, mutagenic or toxic for reproduction and substances
having endocrine disrupting properties;
- the introduction of detailed provisions on conducting
clinical investigations for medical devices with clearly
defined rules and obligations on manufacturers, sponsors,
participating subjects and the relevant authorities on informed
consent, ethics committees, incapacitated subjects, minors,
pregnant women, transparency;
- the introduction of provisions for the reprocessing
of single use devices: reprocessing may only take place if
allowed under national law, however, Member States may go beyond
these provisions in further restricting or prohibiting this
practice on their territory;
- the strengthening of 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 for them to successfully conduct their
conformity assessment activities;
- the strengthening of the authorisation procedures and
the overall system for traceability of devices through the
obligation for manufacturers to apply a post-market surveillance
system according to the risk class and the type of
device.