New EU rules on medical devices

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New EU rules to ensure safety of medical devices

Brussels, 5 April 2017

The European Parliament and Council of Ministers adopted two new Regulations replacing the old Directive on Medical Devices (Dir. 93/42/EEG). The new rules cover medical devices and in vitro diagnostic medical devices, which include simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements.

People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. The current rules on the safety and performance of medical devices in the EU were harmonised in the 1990s. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the Commission proposed to update the rules to improve the safety of medical devices for EU citizens, create the conditions to modernise the sector and to consolidate its role as a global leader.

Read the press release by the European Commission

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