The 12th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notified bodies available in the European Commission’s NANDO information system.
The new notified body is Sertio Oy and based in Finland. For more information concerning the new designated notified body, please click here.