MEDICAL DEVICES AND VITRO IN DIAGNOSTIC MEDICAL DEVICES REGULATION The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal

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The recent scandals related to metal-on-metal artificial hips or faulty silicone breast implants have strengthened the case for modernising current rules for medical devices.

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.

The two new EU regulations (MDD & IVDMDD):

-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.

Go to European Council

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