Thursday, April 23, 2020

European Union postpones new requirements for medical devices

On Friday, April 17, 2020 The European Parliament has adopted the Commission proposal to postpone the implementation of new approval rules for medical devices,


New regulations for medical devices, expected to be fully applicable on May 26, 2020, proposed to be postponed for 1 year (new effective date May 26, 2021).


In a press release by the European Parliament they note;


“The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”


The European Member States will need to approve the proposal and publish in the Official Journal of the European Union. Expectations are this will happen prior to May 26, 2020.


The In Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal, and its applicability date remains, effective May 26, 2022.




EU Parliament press release


New regulations on medical devices

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