04.07.2022
To the attention of laboratories in the field of in vitro diagnostics in Romania and all interested parties
Please be advised that two implementing acts related to the application of Regulation (EU) 2017/746 were published on 22.06.2022 in the Official Journal of the European Union, namely:
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
Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
These refer to the requirements which must be met by laboratories in order to be recognized as EU reference laboratories, their duties and the tariffs which they will charge when carrying out specific activities.
The evaluation and designation of these laboratories will be done by the European Commission, with the collaboration of the Joint Research Center (JRC), based on the proposals of national authorities.
The NAMMDR, as the responsible national authority, receives requests from laboratories in Romania which intend to become reference laboratories, in view of a preliminary evaluation.
Requests for information can be sent via e-mail: dgdm@anm.ro. The regulations are posted under the “Medical devices – European regulations on medical devices” section.