Progressive Roll Out of the IVDR Confirmed by EU Parliament and Council
The European Parliament and European Council recently approved the progressive roll-out of the In Vitro Medical Devices Regulation. In this update, we look at the effect of this approval.

 

The In Vitro Medical Devices Regulation (Regulation (EU) 2017/746)  (IVDR) sets out the new regulatory framework for in vitro diagnostic (IVD) medical devices. To prevent disruption to the supply of essential medical devices as a result of Covid-19 pandemic related delays, in October 2021, the European Commission (Commission) proposed a progressive roll-out of the IVDR, as discussed in our earlier article. The adoption by the European Parliament and European Council of the Commission's proposal will allay fears of an IVD certification bottleneck and product shortages. 

Amended Transitional Periods

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

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

 

Key Contacts

Related Practice Areas