Transition period for the MDR application extended

The transition period for EU Regulation 2020/561 amending the Medical Devices Regulation (EU 2017/745) was extended by one year on 24 April. The Council and the European Parliament adopted the European Commission's proposal with Regulation 2020/561 amending Regulation EU 2017/745, which extends the transition period for MDR by one year until 26 May 2021. The deadline for the validity of MDR CE certificates remains until 26 May 2024.

The special measure was triggered by the COVID-19 outbreak, which may have harmed several areas covered by Regulation (EU) 2017/745. For example, the availability of medical devices on the market, which is crucial in the context of COVID-19, and the designation of Notified Bodies. To ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, and to avoid potential market disruption, EU Regulation 2020/561 entered into force on the day of its publication.

This postponement relieves the burden on national authorities, healthcare institutions, notified bodies and actively involved economic operators. Besides, the postponement of the transition period aims to avoid the shortage of essential medical devices on the market and to allow Notified Bodies and economic operators to complete the implementation of the MDR in a timely and appropriate manner.

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