Proposals for Regulations on Medical Devices

The European Commission today proposed two Regulations, which are going to ensure better quality and safety of the medical devices and in vitro diagnostic medical devices, as well as adaptation to the scientific and technological progress in this field. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn. Main elements of the proposals include: stronger supervision of independent assessment bodies by national authorities; clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales; stricter requirements for clinical evidence, to ensure patient and consumer safety. The proposed regulations will replace the existing Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. For more information, please visit the Commission’s website.