Due to false information spread on the market, please let us inform our clients and interested parties about current state of our designation and notification according to the MDR and IVDR.
Please, click here to see the diagram.
Regarding designation process according to the Regulation (EU) 2017/745 on medical devices, we received and MDCG recommendation. In the following days of this week (33rd week) we expect the designation of national designating authority to be granted and forwarded to the NANDO database for notification. After expiry of time-limits stated in the regulation we expect our notification to be published.
Regarding designation process according to the Regulation (EU) 2017/746 on in vitro diagnostic medical devices we are waiting for a joint assessment date to be fixed.
We have always been transparent in current state of our designation process. In case you are interested about current state of play in the future, do not hesitate to contact us or national designating authority, which is Slovak Office of Standards, Metrology and Testing, Department of Testing and European Affairs.