Safer medical devices: Council adopts new EU rules

Latest Information from the Council of the EU

Press Release 7th March 2017

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

Medical devices and in vitro diagnostic medical devices help diagnose, prevent and treat or alleviate diseases. They cover a wide range of products, from sticking plasters to hip replacements and hearing aids, and from pregnancy tests to HIV tests.

The new rules keep pace with recent technical developments. Their scope has been extended to cover certain products which do not have a specifically medical purpose, such as coloured contact lenses. The experience of metal-on-metal artificial hips and faulty silicone breast implants also has been taken into account in the preparation of the new rules, in particular by requiring the 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 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.

Regulation on medical devices

Regulation on in vitro diagnostic medical devices

Reform of the EU rules for medical and in vitro devices

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Jérôme Unterhuber +32 22815394 / +32 473923628