The European Commission proposed two Regulations that aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95 billions.

Two project Regulations were presented by the European Commission with the aim at ensuring that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. According to John Dalli, Health and Consumer Policy Commissioner, the proposals significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector. In February 2012, Commission called on Member States for immediate actions to implement current legislation on medical devices.

In particular, all devices will have to undergo thorough assessment of safety and performance before they can be sold on the European market. Moreover, healthcare professionals will be provided with better information on the benefits for patients, residual risks and the overall risk/benefit ratio, helping them make the best use of medical equipment in their treatment and care of patients. Also, manufacturers will benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.

The proposals intends, among other things, to get a wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software. Also, a stronger supervision of independent assessment bodies by national authorities, and more powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing. Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales are foreseen in the proposals.