Last 15 March, the EU agreed on an extension of the transition periods provided for in the regulations governing medical devices and in vitro diagnostics. The Council of the European Union adopted the Commission’s proposal to give notified bodies and manufacturers more time to certify medical devices and thereby mitigate the risk of shortages. This followed the positive vote by the European Parliament last month. The legislative proposal provides a longer transition period to adapt to new rules foreseen under the Medical Devices Regulation, ensuring continued access to medical devices for patients in need.
The Commission will work together with Member States and all stakeholders to provide the necessary support to implement this legislative amendment.
Background
The Medical Devices Regulation has been applicable since 26 May 2021. It provides for a transition period until 26 May 2024. The transition to the new Regulation has been slower than anticipated and healthcare systems in the EU are facing a risk of shortages.
At the EPSCO Council on 9 December 2022, EU Health Ministers called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Devices Regulation. The Commission submitted a proposal on 6 January 2023, which was negotiated by the European Parliament and the Council in an urgency procedure.
The regulations
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 regulationsEN••• 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 2027/745 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.
