At its inception, the revision of the EU legislation on medical devices proved to be justified in the light of several public health scandals arising because of defective medical devices. Stricter rules were necessary as regards the market access and testing of medical devices, adequate market surveillance, increased transparency and information.

Under the newly adopted Regulation on medical devices, market access for high risk devices will be significantly strengthened while not going as far as introducing a central authorisation procedure as for medicinal products as proposed by ESIP. Nonetheless high-risk devices will now be required to undergo clinical investigations except in some specific cases.

Market surveillance of medical devices will also be improved. In particular, the creation of a Unique Device Identification (UDI) system should enhance the traceability of devices. In addition, the notified bodies will be empowered to instruct manufacturers on carrying out market surveillance.Their role will be further strengthened thanks to the establishment of the Medical Device Coordination Group, the expert panel called for by ESIP.

Finally, the extension of the European database on Medical devices (Eudamed) is a major step forward for transparency. Information on medical devices available in the European Union, especially on the clinical assessment of implantable devices and Class III devices is essential to ensure independent decision-making and patient safety.

Find out more in our press release.