Regulation (EU) 2017/745

Since 26 May 2021, the medical devices placed on the market by Nausicaa Medical Company meet the requirements of Regulation (EU) 2017/745. The objectives are to harmonise the application of the rules within the European Union to ensure the traceability and identification of any medical device throughout its life cycle.

This Regulation considerably reinforces the prerequisites for obtaining the CE marking and the tools for traceability and transparency.

All products have an EU declaration of conformity as required in the Regulation.

From that date all the obligations of the manufacturer (Article 10 of the Regulation) shall apply, including post-market monitoring.

Nausicaa Medical undertakes to provide you with EU user manuals and declarations of conformity.