25.07.2022
To the attention of in vitro diagnostics laboratories in Romania and all interested parties
The European Commission Directorate-General for Health and Food Safety (DG SANTE) officially launches a call for applications for the designation of EU reference laboratories in the field of in vitro diagnostic medical devices, in line with Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
In accordance with Article 100(1) of Regulation (EU) 2017/746, applications can only be submitted by Member States through the competent authority.
Laboratories intending to register in order to be designated as an EU Reference Laboratory must strictly comply with several requirements and application deadlines.
Member States are requested to submit registration applications for designation by 31 March 2023, 12:00 CET. The deadline cannot be extended and any application submitted after this deadline will not be considered.
In order to meet this deadline, it is recommended that candidate laboratories submit their applications to their Member States by 12:00 CET on 5 January 2023.
The tasks and criteria that must be fulfilled by reference laboratories of the European Union in the field of in vitro diagnostic medical devices for can be found in the Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices.
This Regulation, as well as more information, are available online:
https://health.ec.europa.eu/latest-updates/setting-scene-eu-reference-labs-high-risk-diagnostics-2022-06-21_en
Those interested are invited to contact the National Agency for Medicines and Medical Devices of Romania in order to obtain all the necessary information in order to register their candidacies at: dgdm@anm.ro.