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EC: Proposal for progressive introduction of IVDR

EC: Proposal for progressive introduction of IVDR

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.

Stella Kyriakides, Commissioner for Health and Food Safety, said: The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable. The pandemic has imposed unprecedented challenges also for our medical devices industry.

However, the proposal of the EC does not change any substantial requirements but would change the transitional provisions to allow a progressive introduction of the IVDR:

  • Higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), would have a transition period until May 2025 and 2026.
  • Lower risk ones such as class B and A sterile devices, would receive a transition period until May 2027.

The Commission also proposes a deferred application of the requirements for devices manufactured and used within the same health institution (‘in-house devices').

No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD Regulation will therefore apply from 26 May 2022 as planned.

The Proposal will now go to the European Parliament and Council for adoption. It comes along with a Q&A document which offers more detailed information on the subject.


EC: Press Release IVDR