The In Vitro Diagnostic Regulation (IVDR) introduces a complex conformity assessment process for high-risk IVDs, including sample verification of Class D products before they can be placed onto the market. The verification is to validate performance claims made by the manufacturer; the verification must be completed by an EU reference laboratory (EURL). EURLs are nominated by member states and designated by the European Commission.
The Medical Device Coordination Group released guidance MDCG 2022-3 to provide clarity and to outline best practices for notified bodies (NBs), EURLs and manufacturers.
- Notified body and EURL document test plan
- Manufacturer and notified body document test plan, as approved by the EURL
- Manufacturer provides samples to the notified body
- Notified body coordinates testing with the EURL
- EURL provides test results to the notified body
- Following verification by the EURL, manufacturers may place the IVD on the market, unless advised otherwise by the notified body
- Continued batch testing, based on the relative risk/impact of the device
MDCG 2022-3 also outlines
- How to determine number of samples for testing
- Guidance on testing frequency
- Minimum criteria for Agreement between the notified body and manufacturer, such as:
- Test plan criteria
- Provision of batch release results
- Financial conditions
- Timeframe in which the notified body must communicate verification results and conclusions (not more than 30 days from receipt of samples)
- Commitment from manufacturer to inform notified body of any changes that may have an effect on the verification of manufactured batches and of any relevant scientific, technical or clinical information which has come to its knowledge, which may have an impact on the scientific or technical validity of the batch verification testing scheme
- Minimum criteria for Agreement between notified body and EURL
Notably, the MDCG guidance states that where an EURL is not yet available for the device, then the EURL related requirements are not applicable to the device. This is relevant because as of today, there are not yet any designated EURLs.
Below is the current status of EURL designation:
- December 2021: EU Commission closed its public consultations on the two EURL implementing acts required per Article 100(8) of the IVDR: Tasks & Criteria and EURL Fees. They are now in the final stages of adoption.
- Q2 2022: Per the 1 April 2022 update to the IVDR Joint Implementation and preparedness plan, this is when the Commission will issue the call for EURL applications.
- Q1 2023: the expected date for the EU Commission to complete assessments and start designating EURLs.
- 26 May 2025: the new IVDR compliance date for Class D IVDs.
The guidance goes a long way on how notified bodies will approach batch verification testing, what needs to be in a manufacturer’s agreement with a NB and how a contract should be structured between an EURL & a NB. But with no EURLs expected to be designated until Q1 2023, full implementation of the process is not imminent.