MDR requirements regarding risk management according to ISO 14971

The Medical Devices Regulation (MDR) is a new EU regulation that replaces the previous Medical Devices Directive (MDD). The aim of the MDR is to ensure a higher level of safety and effectiveness for medical devices on the EU market. An important aspect of MDR compliance is risk management, which is covered in the ISO 14971 standard. In this article we will answer the following questions: "What documents are required for MDR certification in terms of risk management according to ISO 14971? What is new in relation to the MDR compared to the previous version of ISO 14971? Which departments should be involved ?"

Documents required for MDR compliance in terms of risk management

To achieve MDR compliance for medical devices, manufacturers must submit several documents related to risk management according to ISO 14971. These documents include:

Risk management plan: This document describes the manufacturer's risk management process and strategy for the medical device.

Risk analysis: This document identifies and assesses potential hazards associated with the medical device, as well as their likelihood and severity.

Risk assessment: This document evaluates the identified risks and determines whether they are acceptable or require mitigation.

Risk control: This document describes the measures to control identified risks.

Post-market surveillance plan: This document describes the manufacturer's plan to monitor the performance and safety of the medical device after it is placed on the market.

Changes in the MDR compared to the previous version of ISO 14971

The MDR brings several changes compared to the previous version of ISO 14971. Here are some of the notable changes:

Extension of scope: The MDR applies to a wider range of medical devices, including those previously considered outside its scope, such as software.

New risk criteria: The MDR introduces new risk criteria for medical devices, such as the state of the art, the benefit-risk ratio and the severity of the condition.

Greater focus on post-market surveillance: The MDR places greater emphasis on post-market surveillance by requiring manufacturers to have a post-market surveillance plan and report serious incidents and field safety corrective actions.

Increased scrutiny of clinical evidence: The MDR requires manufacturers to provide more robust clinical evidence to support the safety and effectiveness of their medical devices.

Company departments that are involved in the risk analysis

MDR compliance requires the involvement of multiple departments within a medical device manufacturer's organization. These departments include:

Regulatory Affairs: This department is responsible for ensuring that the medical device complies with the requirements of the MDR and other relevant regulations.

Quality Assurance: This department is responsible for ensuring that the medical device meets the necessary quality standards and that the risk management process is effective.

Research and Development: This department is responsible for developing the medical device and ensuring that it meets the necessary safety and effectiveness requirements.

Clinical Affairs: This department is responsible for conducting clinical studies and providing clinical evidence to support the safety and effectiveness of the medical device.

Post-market surveillance: This department is responsible for monitoring the performance and safety of the medical device after it is brought to market.