New EU rules on medical devices to enhance patient safety and modernise public health
The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
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.
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 of the Regulation of in vitro diagnostic medical devices.