02.03.2022
To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties
We inform you that a public consultation has been launched on the European Commission’s website regarding the Draft Implementing Regulation and its Annex on common specifications for certain Class D medical devices according to Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The deadline for submitting comments is 9 March 2022.
This document is available online: In vitro diagnostic medical devices – common specifications (europa.eu)