03 Aug Post-Market Surveillance Under EU MDR 2017/745 and IVDR 2017/746
An In-Depth Guide for Manufacturers
Post-market surveillance (PMS) is a critical regulatory requirement for medical devices and in vitro diagnostic devices within the European Union. The EU MDR 2017/745 and IVDR 2017/746 lay down specific guidelines for post-market surveillance to ensure ongoing safety, performance, and quality of these products. This comprehensive guide aims to provide manufacturers with an in-depth understanding of post-market surveillance requirements.
1. Post-Market Surveillance Plan
a. Purpose and Scope: The post-market surveillance plan must outline the strategies for collecting and analyzing data related to the safety and performance of the device. It must be tailored to the specific device and its associated risks.
b. Data Sources: The plan must include both proactive and reactive methods, utilizing sources such as customer feedback, scientific literature, and public health information.
c. Methodology: The methodology for assessing data, including statistical methods and risk management, must be detailed.
Reference: MDR Article 84, IVDR Article 78
2. Post-Market Clinical Follow-Up (PMCF) / Post-Market Performance Follow-Up (PMPF)
a. Objectives: PMCF or PMPF studies are designed to confirm the safety and performance of the device during its intended use.
b. Study Design: The design must be appropriate to the device and its risks, including the selection of control groups and endpoints.
c. Reporting: Results must be included in the PSURs or PPERs and the technical documentation.
Reference: MDR Annex XIV, IVDR Annex XIII
3. Periodic Safety Update Reports (PSURs) / Periodic Performance Evaluation Reports (PPERs)
a. Frequency: Manufacturers must submit these reports at regular intervals, depending on the risk classification of the device.
b. Content: The reports must summarize the results of post-market surveillance activities, including adverse events, trends, risk assessments, and corrective actions.
c. Submission: The reports must be submitted to the relevant competent authorities and notified bodies.
Reference: MDR Article 86, IVDR Article 81
4. Vigilance Reporting in Post-Market Surveillance
a. Incident Reporting: Manufacturers must report serious incidents and field safety corrective actions promptly.
b. Investigation: Thorough investigation of incidents is required, including root cause analysis.
c. Communication: Effective communication with authorities, notified bodies, and other stakeholders is essential.
Reference: MDR Article 87-90, IVDR Article 82-85
5. Trend Reporting in Post-Market Surveillance
a. Analysis: Manufacturers must analyze trends in non-serious incidents and other relevant data.
b. Reporting Threshold: Reporting is required if trends could result in a serious public health threat.
Reference: MDR Article 88, IVDR Article 83
6. Cooperation with Authorities in Post-Market Surveillance
a. Inspections and Audits: Manufacturers must cooperate with regulatory authorities in inspections or audits related to post-market surveillance.
b. Compliance Verification: Authorities may verify compliance with post-market surveillance requirements.
Reference: MDR Article 93, IVDR Article 88
7. Record Keeping for Post-Market Surveillance
a. Documentation: Detailed records of post-market surveillance activities must be maintained.
b. Accessibility: Records must be readily available for review by authorities.
Reference: MDR Article 83, IVDR Article 77
Conclusion
Post-market surveillance under EU MDR 2017/745 and IVDR 2017/746 is a complex and essential aspect of medical device and in vitro diagnostic device regulation. Manufacturers must develop robust post-market surveillance systems that align with the specific requirements outlined in these regulations.
For further guidance, manufacturers may consult the official texts of MDR 2017/745 and IVDR 2017/746, or seek professional assistance from regulatory affairs experts or notified bodies.
Additional resources:
MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
No Comments