This document, released in September 2023 by IGJ (Inspectie Gezondheidszorg en Jeugd), outlines the regulatory framework for post-market surveillance (PMS) of medical devices in the Netherlands, focusing on the requirements set forth by the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR). The aim of PMS is to monitor and ensure the safety, effectiveness, and performance of medical devices after they have been introduced to the market.
The document highlights that since May 2021 (MDR) and May 2022 (IVDR), medical device manufacturers are obliged to comply with PMS requirements. IGJ has conducted surveys and inspections to assess the extent to which manufacturers adhere to these requirements.
The key elements of the document include:
- Required Documentation: Manufacturers must have a PMS plan for each medical device, aligned with its nature, intended use, and risk class. This plan should be well-documented and substantiated.
- Frequency of Reporting: Reporting frequency varies by risk class. Class IIa devices require PSUR updates at least every two years, while higher-risk classes (IIb, III, C, and D) necessitate annual PSUR updates.
- Data Sources: Manufacturers should use appropriate data sources, aligned with the goals of their PMS plan, to gather relevant information. This may include information from users, distributors, technical literature, databases, and more.
- Analysis: Manufacturers must systematically analyze data from defined sources. They should use indicators and threshold values for continuous benefit-risk assessment and risk management.
- Results and Conclusions: The PMS report (or PSUR) should contain conclusions regarding the renewed benefit-risk ratio based on the gathered data.