Medical device regulation
The MDR introduces new and stricter requirements for the placement of medical devices and their distribution within the EU with the main goal to improve clinical safety and traceability of all medical devices.
It also introduces the new central European Database on Medical Devices (EUDAMED), where all medical devices placed on the EU market will be registered, and much more.
In August 2021 we have already succesfully passed quality system audit according Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR).