Reporting Requirements According To Regulation (Eu) 2017/745 - MAVIG GD50S101-PH Gebrauchsanweisung

Risk of injury
SAFETY
RELEVANT
Do not move any covers, or open any cable ducts, etc.!
The IEC 60601-1:2005 certification applies to the non-electrified system. The system must therefore
be re-certified by an appropriately trained technician after the installation of monitors, wiring, etc.
1.4.

Reporting Requirements according to Regulation (EU) 2017/745

Since the products are not a medical device in the sense of the EU Medical Device Regulation
2017/745 (MDR), there are also no statutory reporting obligations according to the EU Medical Device
Regulation 2017/745 (MDR).
DOK-ID: GDX01G01, BE #6600013 16 / 22