Until now, independent certification bodies, approved by Member States, provided authorisation to medical devices coming into the market.

Some MEPs are calling for a centralised EU authorisation of medical devices, however the Commission will not propose this for the Medical Devices Directive (MDD). Eucomed, which represents the medical technology industry in Europe, stressed that with centralisation, patient safety and the speed at which patients receive urgently needed medical devices are compromised.

The revision of MDD aims at establishing a centralised oversight system to ensure that certification bodies are operating appropriately, rather than there being the need to overhaul the existing system.

The MDD file is currently under discussion in the European Commission. On 26 September, the European Commission proposed new legislative rules.

Further information:


EPHA related articles:

- EPHA Briefing on Medical Devices Directive
- European Commission proposes mandatory use of medical devices database
- Commission launches revision of the Medical Device Directives

Last modified on October 9 2012.