MDR compliance
Medical Device Compliance for the European Union
Structure MDR obligations into a practical and reviewable compliance programme.
Start with device-specific requirements
Regulatory requirements depend on the device, intended purpose, classification, manufacturer status and conformity-assessment route.
Typical review areas
- Device qualification and classification.
- Manufacturer and economic-operator responsibilities.
- Technical documentation.
- Risk management and clinical evidence.
- Labelling and instructions for use.
- Declaration of Conformity.
- UDI and registration requirements.
- Post-market surveillance.
Class I is still regulated
Manufacturers of Class I devices remain responsible for MDR compliance, technical documentation and post-market activities even where a Notified Body is not required for the general conformity route.