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.