A Progressive Roll Out of the IVDR
The European Commission proposes a progressive roll-out of the In Vitro Medical Devices Regulation (IVDR).

 

The In Vitro Medical Devices Regulation (Regulation (EU) 2017/746)  (IVDR) sets out the new regulatory framework for in vitro diagnostic medical devices. Although the IVDR's general application date remains 26 May 2022, in October 2021, the European Commission (Commission) proposed additional transition periods for certain devices. The additional periods were prompted by the impact of Covid-19 and the diversion of resources needed to address the crisis, and that only six notified bodies have been designated under the IVDR, resulting in a shortage of notified body capacity. 

The Commission's Proposal

The IVDR will fully apply from 26 May 2022 for the following devices: 

  • CE-marked devices which do not need any involvement of notified bodies under the IVDR;
  • New devices which do not have a notified body certificate or a declaration of conformity under the current In Vitro Diagnostic Medical Devices Directive.

The amended transitional period will depend on the type of device in question: 

 Class of IVD Proposed end of transitional period 
Higher risk devices such as class D devices (including HIV or hepatitis tests) May 2025 
Class C devices (such as influenza tests) May 2026 
Lower risk devices in class B and A (such as sterile devices)  May 2027
Devices that are manufactured and used within the same health institution (in-house devices)  May 2024
IVDs with a certificate under the IVDD (issued by a Notified Body before 26 May 2022) May 2025

Next Steps

The proposal, which has received a lukewarm reception from industry stakeholders, will now go to the European Parliament and Council for adoption. We recommend that manufacturers immediately determine what classification of IVD their products fall into, and consider how best to comply with the proposed new deadlines from May 2022. We will continue to monitor further updates from the Commission and Health Products Regulatory Authority and keep you updated. 

If you require additional information on any aspect of the MDR or IVDR, please contact Charleen O'Keeffe. 

 

Contributed by Aisling Casey, Sinéad Cullen

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