Industry and the Commission agree that the regulatory framework for medical devices is appropriate but there is room for improvement in its implementation at national level.
The Communication follows the overall assessment provided by
the Commission’s Medical Device Expert Group (MDEG) of this
Directive. The Commission largely endorses the MDEG’s statement
concluding that the legal framework for this group of products is
appropriate while its implementation needs to be improved. This
refers, in particular, to the areas of conformity assessment,
transparency and trust, market surveillance and co-operation
between Member States and the Commission.
The Commission recommends a comprehensive action
programme to achieve improvements in current measures involving all
actors on the:
- implementing measures at national level (on the designation of
notified bodies as well as market surveillance);
- use of instruments available under the Directive (including
re-classification, the precautionary principle, the safeguard
clause and formal objection to standards);
- guidance documents on implementation;
- regulatory clarification on a number of issues;
- co-ordination of activities, to be achieved, in particular, by
setting up a new
High Level Group on Medical Devices.
The Commission Communication finds that no
comprehensive data on the medical devices sector is currently
available and it therefore announces a new study to be conducted in
order to improve knowledge of the sector, to uncover its impact on
public health expenditure, and to explore the conditions for
increasing its competitiveness.