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European Commission postpones application of the Medical Devices Regulation

Medical device European legislations are in transitional period between 3 existing directives and 2 new European regulations. The new regulations would be fully applicable on 26th May 2020 for medical devices, but on 3rd April 2020, the European Commission published the following proposal:

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions. (COM/2020/144 final)

This proposal postpones, for exceptional reasons in the current context (COVID -19), the application of the Medical Devices Regulation by one year (until 26 May 2021). The goal is to have the Parliament and Council adopt the proposal by the end of May 2020.

This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

For more information, please consult the European Commission website here.