What is MDR?
A new medical device regulation that all medical device manufacturers looking to enter the European market must comply with as of May 26, 2020.
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MDR Product Classification
- A new medical device regulation that all medical device manufacturers looking to enter the European market must comply with as of May 26, 2020. This replaces the EU’s current Medical Device Directive (93/42/ECC) and Active Implantable Medical Devices (90/385/EEC) guidelines, which officially went into effect on 25 May 2017. The existing MDD certificates are valid until May 26, 2024, and must comply with the MDR's requirements for certification of new products.
Class
Risk
Necessity of clinical trial
Class I
Minimal
X
Class IIa
Low to Moderate
X
Class IIb
Moderate to High
O
Class III
High
O
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