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|
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