News about GMP/cGMP

24.04.2020

EU MDR: Decision on delay by one year

On 17 April 2020, the European Parliament voted by 693 to one votes and with two abstentions to delay the entry into force of the EU Medical Device Regulation (MDR) by one year - to 26 May 2021. 

Initially, the MDR was to apply from 26 May 2020. However, due to the Covid 19 crisis, medical device manufacturers experience heavy workloads in providing the necessary medical devices. To avoid shortages, six Members of the European Parliament submitted a proposal calling for a delay of the MDR (we reported).
The new date of entry into force is expected to be published in the Official Journal of the European Union on 26 May 2020.
The EU In-Vitro Diagnostic Medical Device Regulation (IVDR) is not affected. As scheduled, it is currently to be applicable as of May 26, 2022. However, MedTech Europe is already calling for this date to be delayed, as, among other things, only a few Notified Bodies have been designated.


Source:

European Parliament: Press release: Parliament decides to postpone new requirements for medical devices

MedTech Europe: MedTech Europe welcomes the amendment of the Medical Devices Regulation and urges similar action for the IVD Regulation



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