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Proposal on progressive roll out of IVDR adopted

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Published on: 21 December 2021

Published by LNB News

LNB News 21/12/2021

Document Information

Issue Date: 21 December 2021

Published Date: 21 December 2021

Jurisdiction(s): European Union

Article summary

The European Commission has confirmed that the proposal to progressively roll out Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) due to a delay in its implementation as a result of the coronavirus (COVID-19) pandemic and the shortage of notified body capacity, has been adopted by the European Parliament and the Council of the European Union. Although, overall, the IVDR will apply from 26 May 2022 as scheduled, requirements for higher risk devices in Class D will now apply from May 2025, for lower risk Class C devices from May 2026 and for lower risk Class devices in Class B and A sterile, the requirements will be applicable from May 2027. In addition, the application of certain requirements for devices manufactured and used in the same health institution will be delayed to May 2024.

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