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 this important sector
covering more than 500 000 products.
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:
- the inclusion of certain products without a medical
purpose in the scope of the medical
devices Regulation, even though the inclusion of the listed groups
of products in the scope of the medical devices legislation is not
automatic, as the Commission proposed, but is dependent on the
adoption of the common technical specifications;
- 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;
- reprocessing of single-use medical
devices: the approach taken by the
Council differs from the Commissions which foresaw that all
reprocessors would be considered as manufacturers and that
single-use devices for critical use could not be reprocessed.
Nevertheless, the Commission considered that the Councils
position appears to be an acceptable way forward to establish
EU-wide minimum rules applicable to the reprocessing of single-use
medical devices and can therefore be supported;
- the use of hazardous substances in invasive medical
devices: if the Council's position
diverges from that of the Commission, it is nevertheless acceptable
as regards the possibilities for identifying and tracking the
devices which the new system will guarantee;
- 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;
- specifying the obligations of manufacturers to
follow-up on the real-life use of their devices after their placing
on the market.