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The entry into application of Regulation (EU) 2017/745 of April 5th, 2017 relating to medical devices (MDR) is postponed by one year

25 April 2020 Marie SANCHEZ

The EU authorities have decided to postpone the entry into application of the MDR, initially scheduled on May 26th, 2020, to May 26th, 2021. The authorities explain this decision by the critical need to avoid any shortages in stock of vital medical devices (MD) during the COVID-19 pandemic. It is also a way to ensure that the parties concerned will be able to implement and make a correct application of the MDR, which would have been impossible on May 26th, 2020, due to the extraordinary difficulties generated by the sanitary crisis and the complexity of MDR itself. 

Regulation (EU) 2020/561 of April 23rd, 2020, published in the OJEU of April 24th, 2020, therefore provides the following modifications to the MDR:

– The application of certain provisions of the MDR is postponed as follows:

– Adaptation of the transitional provisions:

– Setting up of a derogation:

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