On November 30th, 2022, the European Commission has published an information pack for candidate laboratories in the context of European Union Reference Laboratories (EURLs) in the field of in vitro diagnostic medical devices.
European Union Reference Laboratories in the field of in vitro diagnostic medical devices – information pack for candidate laboratories) (version 3 – November 2022)
This is a very important document for the Reference Laboratories approach. The information pack covers following topics:
- Which IVDs need EURLs (class D devices)
- How is the conformity assessment done
- What are common specifications
- The legal framework for EU Reference Laboratories
- Overall selection process and it’s practical aspects
As regards conformity assessment, the EURL performs laboratory testing of the devices as follows:
- PRE CE-mark:
- verification that the device performs according to the claims of the manufacturer (and according to the common specifications when available and used by the manufacturer)
- batch testing
- POST CE-mark:
- batch testing
It further clarifies that the EURL, in order to verify the manufacturer’s claim on the performance of the device, they should not repeat the performance studies carried out by the manufacturer but should come up with a suitable protocol to verify the performance and compliance with common specifications or other solutions chosen by the manufacturer.
Designation of the EURL is expected in Q3 2023. In the absence of EURLs, Notified Bodies can issue certificates for class D devices. However, once a EURL is designated for a group of IVDs, all devices that belong to that group must be tested by the EURL which will have to confirm the registration.
What does this mean to you?
This information pack for EURL is very relevant for all class D manufacturers, as it gives detailed information on the tasks and assignments of the EURLs.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.