Medical device CE marking

Notified Body confirmation letter in the framework of Regulation (EU) 2023/607


In May Team-NB published a confirmation letter to be completed by Notified Bodies under Regulation 2023/607. This confirmation letter is not intended to be completed by the manufacturer. The Notified Body of the manufacturer may complete the template on request of the manufacturer, as described in the EU Commission Q&A document on Regulation 2023/607 (Q7).

The template can be downloaded in our library

Source: European Commission