Safer Medical Devices: Council adopts new EU rules


07-Mar-2017
On 7 March 2017, the Council adopted new rules to improve the safety of medical devices while preserving a timely access to innovative healthcare solutions.

Medical devices are used for diagnostic, preventative and treatment purposes and cover a vast range of equipment, from plaster to hearing aids and from pregnancy tests to HIV tests.

The Council’s adoption help to stay updated with the latest technical developments. The new rules now cover certain products which are not specifically tied to a medical treatment, such as coloured contact lenses. The new rules entail new procedures such as systematic scrutiny of vital implants by medical experts.

"Medical devices play a crucial role in all our lives. We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market”
​Mr Christopher Fearne, Minister for Health of Malta and President of the Council.

The two new EU regulations

  • provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies to meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices

  • improve the availability of clinical data on devices and clearly set out manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data

  • improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems

  • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions


Next steps

The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices