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European Commission proposes to amend the transition provisions of the IVD Regulation

Posted on 04.11.2021

The European Commission has submitted a proposal for amending the In Vitro Diagnostic Regulation’s transitional provisions. This follows calls in the past months from the European Parliament and Council for legislative action to address the Regulation’s transition challenges. A communication from MedTech Europe on the proposal may be found here. The next steps are for the European Parliament and Council of the EU to decide if they support the proposal or wish to amend it. The timeline for a decision is currently unknown.

What is in the proposal? Below are paraphrased excerpts from the European Commission’s Q&A document:

  • Is the application of the entire Regulation postponed? No. The general application date of the Regulation remains 26 May 2022. In particular, the IVD Regulation will apply in full from 26 May 2022 to CE marked IVDs that do not require the involvement of a notified body (i.e. class A non-sterile devices which represent around 20% of the market) and to ‘new’ IVDs (i.e. those not covered by a certificate or a manufacturer’s declaration of conformity issued prior to 26 May 2022).
  • Article 110 of the IVD Regulation provides for a transitional period until 26 May 2024 for IVDs with a certificate issued by a notified body in accordance with the IVD Directive prior to 26 May 2022. This transition period would be extended by 1 year until May 2025.
  • The European Commission is proposing additional transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVD Regulation. The proposal differentiates between risk classes, with a transition period until May 2025 for high risk devices (class D), until May 2026 for class C devices and until May 2027 for lower risk devise (class B and A sterile).

The Commission proposes to defer the application of most of the conditions to be met by health institutions making in-house devices by 2 years until 26 May 2024. The requirement for the justification that there is no equivalent CE marked device available to meet the target patient group’s specific needs is proposed to be deferred even further, until 26 May 2028, as the health institutions will need an overview of CE-marked IVDs available on the market to comply with this requirement.

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