In response to the global COVID-19 crisis the European Parliament and Council have decided to postpone the application date of the MDR.
The new EU Medical Devices Regulation (MDR) was set to come into action on 26 May 2020. In order to prioritize the fight against the COVID-19 outbreak the European Commission (EC) announced on 25 March 2020 that it had put in motion the drafting of a proposal to postpone the application date. On 3 April the proposal to postpone MDR for one year until 26 may 2021 was adopted and published by the EC.
The proposal required full support from both the European Parliament and the Council to be approved through the accelerated co-decision procedure – a procedure where the Parliament and Council jointly can adopt legislation by consensus.
The proposal from the Council was approved by overwhelming majority in the Parliament effectively deferring the application date of MDR to 26 May 2021.
This postponement will provide more time for economic operators, notified bodies, national authorities and the EC to implement the various requirements of the MDR. The postponement will also provide additional time for manufactures of medical devices applying for Medical Devices Directive (MDD) certificate renewals.
The proposal also includes certain MDR-related transitional provisions to apply even though they would otherwise not apply under MDD and other directives. For instance, the proposal suggests the adaptation of EU-wide derogations in response to national derogations in order to address potential device shortages. Derogations allow national authorities to place certain devices on the market even if the conformity assessment procedures have not been carried out yet.
The EC proposal does not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation (IVDR), which currently is due to come into force on 26 May 2022. There has not yet been announced plans to implement a corresponding postponement for IVDR.
The EC announced back in October 2019 that EUDAMED — the new database for device registration under MDR and IVDR – would be delayed and not operational until May 2022. As with the IVDR there has been no information about whether or not this date will be similarily pushed back.