Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

These EURLs will have several important tasks such as monitoring the performance of IVDs of the highest risk class (class D) and testing batches of manufactured IVDs of class D. The possible tasks of EURLs and the criteria to be fulfilled by EURLs are listed in articles 100(2) and 100(4) of Regulation (EU) 2017/746 and further detailed in the Implementing Regulation (EU) 2022/944. The tasks for which EURLs may charge fees are listed in Implementing Regulation (EU) 2022/945.

All information about EURLs, the call for applications and practical information are available below.

• Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices
• Information pack for laboratories (new version: December 2022)
• Annex I: scopes of designation and estimated minimum EU-wide capacity
• Annex III: knowledge and experience requirements of staff
• Annex IV: estimated minimum capacity of the candidate laboratory
• Annex V: declaration on honour regarding exclusion criteria
• Annex VI (a): criteria used for evaluation of economic and financial capacity
• Annex VI (b): simplified presentation viability checks
• Annex VII: declaration of independence
• Annex VIII: template for a simulation of a work programme
• Annex IX: application form for single laboratories
• Annex X: application form for a consortium

Only the competent authority for IVDs, the FAMHP in Belgium, can submit applications to the European Commission. The FAMHP must also first perform a check on these applications. Candidate laboratories can send their application file to recast.meddev@fagg-afmps.be with the subject "candidacy EURL - name laboratory". Applications can be submitted until 10 January 2023.