New EU rules on medical devices
BRUSSELS, Belgium: The European Commission today adopted two Regulations on medical devices which establish a modernised and more robust EU legislative framework. To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period, namely 3 years after publication for the Regulation on medical devices and 5 years after publication for in the Regulation on vitro diagnostic medical devices.
The new Regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices - from heart valves to sticking plasters to artificial hips – are safe and perform well. To address this, the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, said: "I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States' market surveillance activities."
The two new Regulations bring a number of improvements for medical and in-vitro devices:
- random inspections of producers’ facilities after devices have been placed on the market,
- stricter controls on notified bodies, which will have to employ medically skilled people,
- an additional safety checking procedure for high risk devices, such as implants or HIV tests. Not only a notified body, but also a special committee of experts, will check that all requirements are met,
- an "implant card" for patients, enabling patients and doctors to track which product has been implanted, and
- clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.
Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.
Strengthen transparency of information for consumers: The new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).
Enhance vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate more closely in the field of market surveillance.
Commission: http://europa.eu/rapid/press-release_IP-17-847_en.htm et http://europa.eu/rapid/press-release_MEMO-17-848_en.htm?locale=EN