New EU rules to ensure safety of medical devices

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.
The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation.

Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017.

With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.

With effect from 26 May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaced Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.

Regulation 2017/745 and Regulation 2017/746 provide for transition periods during which devices that are in conformity with the previous Directives can still be placed on the EU market.

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

More info and details can be found here.

Official press release from the European Commission.