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In July 2022, the EU Commission launched a formal call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices under the IVDR. The purpose of this call is to invite Member States to submit applications for laboratories in their jurisdictions in view of their possible designation as EU reference laboratories. The European Commission may only designate the EU reference laboratories for which a Member State or the European Commission’s Joint Research Centre has submitted an application for designation.
Laboratories in Ireland wishing to apply for consideration for designation should refer to the Health Products Regulatory Authority (HPRA) website European Union Reference Laboratories (EURLs) for IVDs (hpra.ie) Here you can find more information on the designation criteria and application process.
Completed applications should be submitted to the HPRA for consideration no later than 5th January 2023 , however the deadline for notifying the HPRA of an intention to apply, is 30th September 2022.
Successful applications will be submitted to the EU Commission for consideration for designation as an EU Reference Laboratory.
An in vitro diagnostic medical device includes any medical device that is used to test human samples outside of the body e.g., testing of blood, urine, saliva, tissue samples, in order to provide information on matters such as a person’s heath status or condition or, to monitor therapeutic measures. Examples of in vitro diagnostic medical devices include Covid-19 tests, pregnancy test kits, genetic tests, urine test strips and blood collection tubes.
In May 2022, the new EU Regulation on in vitro diagnostic medical devices (IVDR) became fully applicable after a five-year transition period. This Regulation represents a significant development and strengthening of the existing regulatory system for in vitro diagnostic medical devices in Europe and replaces the framework that was previously in place.
Article 100 of the IVDR provides for the designation of European Union reference laboratories. Designated laboratories will be required to perform certain functions in line with Article 100 of the IVDR, as further specified by Commission Implementing Regulation (EU) 2022/944.