MDR
The regulation on medical devices (Medical Device Regulation) is an EU regulation that must guarantee the safety and performance of medical devices (equipment). The aim is to improve patient safety by introducing stricter methods of assessment and monitoring in the market.
What does MDR mean?
MDR stands for Medical Device Regulation, an EU regulatory framework for medical devices.
When did the MDR start to apply?
MDR started to apply on 26 May 2021.
Which classes are medical devices divided into according to the MDR?
Four classes: I, II a, II b and III. The classes are based on the risks that the patient may be exposed to.
The extent to which a notified body must review compliance depends on the product’s risk class but also other factors, if, for example, the product is delivered sterile.
Class I: Lowest risk, often simpler products.
Class IIa: Low to moderate risk.
Class IIb & III: High risk potential.
Why MDR?
The MDR shall ensure and improve patient safety and the performance of medical devices within the EU.