MDR regulation and CE

The MDR, or Medical Device Regulation, is a European regulation that came into force on 26 May 2021 and sets new rules for medical devices and in vitro diagnostics. This regulation replaces the previous MDD (Medical Device Directive) and aims to ensure the safety and performance of medical devices and increase transparency for patients.
Key points of the MDR:
Stricter requirements:
The MDR imposes stricter requirements on manufacturers, importers and distributors of medical devices than the previous MDD.
CE marking:
Medical devices may only be placed on the European market if they bear a CE marking, which demonstrates that they comply with the requirements of the MDR.
Stronger market authorisation system:
The MDR strengthens the system for authorising medical devices on the market, with a greater emphasis on safety and performance.
Greater transparency:
The MDR promotes transparency for patients and healthcare providers through better traceability of devices and more information about the products.
Supervision:
The Health and Youth Care Inspectorate (IGJ) in the Netherlands has been designated as the supervisory authority for compliance with the MDR.
What does the MDR mean for healthcare providers and patients?
Healthcare providers:
Must be aware of the new rules and ensure that the medical devices they use comply with the MDR requirements.
Patients:
Are entitled to clear information about the medical devices they use and can have greater confidence that these devices are safe and effective.
In short, the MDR is an important step towards greater safety and transparency in the world of medical devices, with consequences for manufacturers, healthcare providers and patients.
All oxygen concentrators we offer comply with the European Medical Devices Regulation (MDR).