According to Article 100 of Regulation (EU) 2017/746, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs). To do this, the European Commission may launch calls to Member States to submit applications for candidate EURLs. Following the assessment of compliance with criteria, the Commission can designate EURLs by implementing act.
The EURLs have two main categories of tasks: advisory ones and those related to market access of class D devices. For market access of class D devices, the EURLs will
- verify the performance of class D devices and compliance with common specifications
- perform batch testing of class D devices
The following implementing acts are relevant for EURLs in the field of IVDs:
- Commission Implementing Regulation (EU) 2022/944 on tasks and criteria for the EURLs
- Commission Implementing Regulation (EU) 2022/945 on fees that the EURLs may levy from notified bodies and Member States
Currently no EURLs are designated under Regulation (EU) 2017/746. In July 2022, the European Commission sent a call for applications to Member States for EURLs in 8 categories of class D devices:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Arboviruses
- Respiratory viruses that cause life-threatening diseases
- Haemorrhagic fever and other biosafety level 4 viruses
- Parasites
- Blood grouping
Candidate laboratories must apply to their Member States. The European Commission has recommended a deadline at 12.00 (CET) on 5 January 2023 for this (Member States may set a different deadline in their country). Following assessment, the Member States must submit applications on behalf of the candidate laboratories to the European Commission, at the latest by 12.00 (CET) on 31 March 2023. Candidate laboratories should contact the relevant authority in their Member State for further information and instructions on how to apply.
The following document is also intended to assist candidate laboratories: