On 2 July, the Commission adopted a Communication on medical devices recommending better use of available measures to improve access to new technologies while maintaining the highest safety levels.
The current regulatory framework for medical devices leaves
room for improvement in conformity assessment for products with
special requirements; transparency and trust among regulators,
stakeholders and the public at large; market surveillance; and
cooperation between Member States and the Commission.
Therefore, this Communication recommends
improvements in current measures, including the reclassification of
devices; the better use of the precautionary principle and
safeguard clause; and the development of guidance documents on
implementation and regulatory clarification.
The Communication takes note that comprehensive
data on the medical devices sector are lacking, and it therefore
calls for a study to be carried out in cooperation with national
authorities and industry in order to improve knowledge of this
sector, its impact on public health expenditure and the conditions
for increasing its competitiveness.
Eucomed, the European Medical Technology Industry
Association, agrees in its initial comments with the Commission
that there is a need to improve the implementation of the medical
devices legislation. Eucomed has expressed support for the creation
of a High Level Group on medical devices and calls for the
involvement of industry in all day-to-day management of issues
relating to medical devices. Reclassification of medical devices
should remain evidence-based, allowing also "down" classification
to a lower risk class besides "up" classification to a higher risk
category, warns Eucomed.
The Commission adopted a Communication on 2 July with the aim
to improve the implementation of the EU's regulatory framework for
medical devices (see also,
EURACTIV LinksDossier on Medical
Medical devices have become a major sector in
health care, both in terms of markets, of public expenditure and of
impact on health. However, it has remained a largely unknown
sector, despite the fact that it represents 26 per cent of
worldwide sales, estimated at EUR 41 billion.