The Commission stated that the Councils position
overall endorsed the objectives pursued by the Commission
proposal, namely to ensure an increased level of patient safety
and public health protection, facilitate the smooth functioning of
the internal market and support innovation in the in vitro
diagnostic medical device (IVD) sector.
The Commission supported the position adopted
unanimously by the Council.
The Commission can accept the amendments made by
the Council to its initial proposal as regards:
- information and counselling for genetic testing in the
context of healthcare: the Commission
stated that: (i) it will report on the Member States' experience
with the implementation of the obligations for information and
counselling in the context of use of genetic tests; (ii) devices
without any medical purpose, including those which are intended to
directly or indirectly maintain or improve healthy behaviours,
quality of life and wellbeing of individuals, are not covered under
the definitions of the Regulation on in vitro diagnostic medical
devices. Nonetheless, the Commission intends to monitor, on the
basis of the market surveillance activities carried out by Member
States, specific safety issues which might be linked to the use of
these devices;
- the exemption of devices manufactured and used in the
same health institution from some
requirements of the legislation, although this exemption is
introduced for the first time for medical devices, the position of
the Council can be supported as it offers acceptable guarantees for
control of these in-house devices;
- financial coverage by manufacturers in case of damage caused by defective medical devices:
the Councils position accepts the spirit of the European
Parliaments 1st reading position introducing a compulsory
liability insurance for manufacturers, but by obliging the
manufacturers to have measures in place to provide sufficient
financial coverage in respect of their potential
liability:
- reinforcing the role and responsibilities for
authorised representatives who would
be jointly and severally liable with the importer and manufacturer
in case of damages suffered due to defective devices;
- the identification and traceability related
obligations and establishment of a Unique Device Identification
(UDI) System: contrary to the
Commissions proposal which only sets out the legal basis and
the main principles of the future UDI system, leaving the details
to the implementation stage, the Councils position sets out
detailed rules for the implementation of the UDI
system.
The Commission is also in favour of the new provisions
aimed at:
- improving transparency of the information contained in
the European Medical Devices Database (EUDAMED);
- strengthening the requirements for the designation and
oversight of notified bodies;
- providing for the consultation of an expert panel on
certain high-risk devices;
- reinforced requirements for clinical investigations
and clinical data and provide for a longer transition period for
the coordinated procedure for assessment of applications for
clinical investigations in more than one Member State;
- specifying the obligations of manufacturers to
follow-up on the real-life use of their devices after their placing
on the market.