In July 2022, the European Commission sent a call for EU reference laboratories under Regulation (EU) 2017/746 to the EU Member States, as well as Iceland, Norway, Liechtenstein and Turkey. The deadline for Member States to submit nominations to the Commission is 31 March 2023. Interested candidate laboratories should contact their Member State for further information and instructions.
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.
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
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Haemorrhagic fever and other biosafety level 4 viruses
- Blood grouping
What does this mean to you?
This publication from the European Commission outlines the steps you should follow if you are a laboratory and are looking into becoming a European Reference Laboratory. If you are a manufacturer this listing may have some impact on the classification of devices into Class D and as such can be an element of significance.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.