In order to provide the necessary modalities as mentioned in Article 100 of the Regulation (EU) 2017/746 concerning the EU Reference Laboratories (EURL), the European Commission has adopted the following two regulations:
- Implementing Regulation (EU) 2022/944:
This regulation establishes the criteria that EURLs must meet in the context of their designation in terms of staff qualification, equipment, best practices, organization, impartiality etc. Furthermore, to support a uniform application of the IVDR, this regulation specifies the conditions under which the tasks of the EURLs must be performed (sample testing, contractual relationship with the notified body etc.).
- Implementing Regulation (EU) 2022/945:
As a EURLs may be requested by a notified body or a Member State to provide scientific/technical assistance or scientific advice, a fee may be charged to cover all or part of the costs incurred by the laboratory carrying out the performance of the requested task. This implementing regulation therefore specifies the modalities for calculating these fees.
These abovementioned regulations enter into force on the twentieth day following their publication, i.e. on 20 July 2022.