Risk Management for Medical Devices EN 14971

The Medical Device Regulation (EU) 2017/745 (MDR) has brought the Risk Management System as part of the Technical Documentation even more into focus than it already was. The implementation and planning of a Risk Management System is required for all Medical Devices.

With the Commission Implementing Decision (EU) 2022/757 in May 2022, EN ISO 14971:2019/A11:2021 was harmonized and is thus the requirement for implementing the Risk Management Process.

Article 10 of the MDR requires that the manufacturer set up, document, apply and maintain a Risk Management System as described in Annex I Section 3. It is understood as an iterative process throughout the entire product life cycle.

The purpose of the Risk Management System is to identify and assess all hazardous situations that arise from the product or are associated with the product, as well as all reasonably foreseeable misuse of the Medical Device in question. The core element is the reduction of the risks of the identified hazardous situations in order to make the Medical Device as safe as possible for the user, patient, third persons and also for the environment. According to EN ISO 14971:2019/A11:2021, risk is defined as the combination of the probability of occurrence of a hazard and the severity of the effect of an occurred hazard. Further steps that must be implemented as part of the Risk Management Process are the assessment and verification of the risk reduction measures taken, as well as a final assessment of the respective hazard situation, including the benefit-risk ratio and any residual risks that may remain despite the risk reduction measures implemented as far as possible.

Details on how to implement this and practical help in creating a Risk Management File can be found in EN ISO 14971:2019/A11:2021 and ISO/TR 24971:2020. The standard and the guideline describe how a Risk Management File is to be structured and which elements and documents it must contain in order to demonstrate conformity with the General Safety and Performance Requirements according to Appendix I of the MDR, in particular Section 3. Due to its iterative character, the Risk Management File must be checked and updated at regular intervals.

Summarized, the Risk Management File must consist of at least the following documents:

• Process description of Risk Management
• Risk Management Plan
• Risk Analysis
• Risk Management Report

Important elements that should be included in the Risk Management File are the definition of a Risk Policy on the basis of which the acceptance criteria for the benefit-risk ratio and the residual risk are defined. Furthermore, the definition of acceptable risks, as well as a listing and evaluation of all known and foreseeable hazardous situations, and a final evaluation of the risk analysis carried out, are necessary. For all activities within the Risk Management Process, it is important that the persons involved can demonstrate appropriate knowledge of the respective process steps and the product life cycle of the Medical Device.

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