The ISO 13485 requires risk management for medical devices “the organisation has to keep records concerning risk management during the complete product realisation process. Records resulting from the risk management have to be recorded.“ Further to this, it refers to ISO 14971 which acts as a guidance for risk management and describes the procedure of risk management. The results of all risk management activities have to be recorded and maintained in the “risk management file“ for each medical device or component. This file may, but need not to be, part of the technical file of the device.
Risk assessment: an evaluation based on the risk analysis, if on the basis of the accepted data a reasonable risk in a given context has been achieved.
Revision of the Medical Device Directive introduces in Annex X the requirements to “actively update“ the clinical evaluation in the technical file. This means that the manufacturer is obliged to systematically obtain and evaluate information during the marketing phase of the device and make this process a part of the overall risk management plan and file.
Guidance on “Post Market Clinical Follow-up“ is provided in the document MEDDEV 2.12-2.