European Parliament adopts proposals to ensure safety of medical devices

The European Commission's proposals on medical devices and in-vitro diagnostic medical devices to ensure better protection of public health and patient safety were adopted by European Parliament on Wednesday.

According to the Commission, the new rules will help to ensure that all medical devices are safe and perform well.

The rules will improve the quality, safety and reliability of medical devices, strengthen transparency of information for consumers and enhance vigilance and market surveillance.

There are over 500,000 types of medical devices and in-vitro diagnostic medical devices in the European Union market. All medical devices, in-vitro diagnostic medical devices and their accessories fall under the new regulations, said the Commission.

The existing regulatory framework dates back to the 1990s and problems with divergences in the interpretation and application of the rules make the Commission presented two legislative proposals on medical and in-vitro diagnostic in 2012.

To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period of three years after publication for the Regulation on medical devices and five years after publication for the Regulation on vitro diagnostic medical devices, said the Commission. Endit