New regulation(EU) 2017/745
on medical devices (EU) 2017/745
NEW REGULATION (EU) 2017/745
From May 26th 2021, the medical devices marketed by Nausicaa Médical will comply with the requirements of Regulation (EU) 2017/745.
The objectives are to harmonize 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 strengthens the prerequisites for obtaining the CE marking as well as the traceability and transparency tools.
All products have an EU declaration of conformity as required by the regulation.From this date, all the obligations of the manufacturer (Article 10 of the Regulation) are applicable, including post-marketing follow-up.
Nausicaa Médical undertakes to provide you with user manuals and EU declarations of conformity.
