The two new EU medical device regulations are intended to improve safety of devices for the benefit of patients, whilst simultaneously maintaining timely access to healthcare solutions. This week, the European Council officially adopted these EU rules – see full press release here.
The intention of the new rules is to keep up with the rate of technical advances in the field of medical devices and in vitro diagnostic medical devices whose purpose is to assist with the diagnosis, prevention, treatment or alleviation of diseases.
With the implementation of these new rules, the regulatory scope has been widened to include certain products for which there is no specific medical purpose, such as coloured contact lenses. The results from recent concerning experiences with medical devices such as faulty breast implants and metal-on-metal artificial hips have been taken into account during the preparation of the new rules, in particular with the inclusion of the requirement for systematic scrutiny of vital implants by medical experts.
The implementation of the two new EU regulations:
- Should give a stronger mandate to independent Notified Bodies when assessing medical devices prior to being marketed, and also strengthen oversight of these bodies by national authorities; the new rules are also intended to guarantee that these Notified Bodies will provide consistently high safety standards throughout the EU; these measures will improve the safety of medical devices;
- The new rules will also make clinical data on devices more available and provide a clear set of responsibilities to the device manufacturer’s regarding their ongoing monitoring of the quality, performance and safety of devices when placed on the market;
- It is anticipated that the rules will also strengthen the traceability of medical devices throughout the entire supply chain through to the end-user or patient by the inclusion of a unique identification number, enabling fast and effective measures to be implemented if a safety issue is identified.
As a result of the new rules, a central database to include comprehensive information on products available in the EU will implemented, allowing patients, healthcare professionals and the public to make better informed decisions.
It is anticipated that the two regulations should be adopted by the European Parliament in April, and they will then be published in the Official Journal.
Following their publication, the new rules will take full effect:
- after 3 years for medical devices
- after 5 years for in vitro diagnostic medical devices.