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.
Eucomed, the European Medical Technology Industry
Association, has issued a four-page position paper on the
Communication in which it agreed with the majority of the
recommendations in the Commission's document. Eucomed, which
represents the medical technology industry in Europe, said it is in
favour of every effort to improve the implementation of the medical
devices directive at national level. The association expressed
concern at the low standing of the CE marking and called for a
special CE marking for medical devices. Eucomed expressed support
for the creation of a High Level Group on Medical Devices, which
should operate with the inclusion of industry and other
stakeholders. Eucomed pointed out that reclassification of medical
devices should remain evidence-based, allowing also "down"
classification to a lower risk class as well as "up" classification
to a higher risk category.
The Commission adopted a set of policy conclusions on 2 July
on the functioning of the medical devices directives, as mandated
by Directive 93/42/EC on medical devices. (see also,
EURACTIV LinksDossier on Medical
Devices). In its Communication, the
Commission concluded that "EU regulatory framework works well, but
arrangements for implementing it could be improved".
It is a little known fact that the European
medical devices sector represents 30 per cent of worldwide sales,
estimated at 54.8 billion euro (Source: Eucomed Industry Profile