New regulation (EU) 2017/745
on medical devices (EU) 2017/745
NEW REGULATION (EU) 2017/745
Since May 26, 2021, the medical devices marketed by Nausicaa Médical meet the requirements of Regulation (EU) 2017/745. The aim is to harmonize the application of rules within the European Union to guarantee the traceability and identification of all medical devices throughout their life cycle.
This regulation considerably strengthens the prerequisites for CE marking, as well as traceability and transparency tools.
All products carry an EU declaration of conformity as required by the regulation.
From this date, all the manufacturer’s obligations(article 10 of the regulation) apply, including post-marketing follow-up.
Nausicaa Médical is committed to providing you with user manuals and EU declarations of conformity.
These documents can be downloaded free of charge from the “Documents” tab on each product page.
