Classification and risk class is fundamental for compliance to the MDR, for all clinical investigations and evaluations concerning medical devices and their manufacturing.

Manufacturer should have the following that is proportionate to the risk class:

Sufficient financial coverage in respect of their potential liability proportionate to the risk class, type of device and size of the enterprise.

Quality management system and a post-market surveillance system that is proportionate to the risk class and type of device.

Risk management system and a system for reporting of incidents and field safety corrective actions in order to minimize risks or prevent incidents related to devices.

The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated.