April 2025 – European Union
Post-Market Surveillance (PMS) is a cornerstone of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), requiring all manufacturers to continuously monitor the performance and safety of their devices once on the market. However, recent inspections by the Dutch Health and Youth Care Inspectorate (IGJ) have highlighted widespread non-compliance with these requirements—particularly among legacy and Class I device manufacturers.
Key Findings from IGJ PMS Inspections
Since late 2023, IGJ has stepped up its audits, focusing on PMS systems. A total of 13 manufacturers were inspected across various device types, including software and in vitro diagnostics. The audits covered PMS plans, PMS reports, Periodic Safety Update Reports (PSURs), and their integration into ISO 13485-certified Quality Management Systems (QMS).
Common deficiencies included:
- Inadequate PMS Planning: Many manufacturers either lacked a documented PMS plan or had one that was unclear or incomplete.
- Incomplete Reports: PMS reports and PSURs often lacked critical information, such as incident differentiation and corrective action indicators.
- Weak Data Management: Insufficient data collection processes and analysis frameworks were found, especially concerning the separation of serious from non-serious incidents.
- Poor Implementation: Although some corrective actions were taken, few were connected to a broader benefit-risk reassessment or clearly defined triggers.
Despite these findings, IGJ also reported that several companies showed improvement upon re-inspection, proving that compliance is achievable with proper system design and resource allocation.
Why This Matters
Failure to comply with PMS obligations under the MDR and IVDR can result in enforcement measures ranging from corrective action requests to suspension of market access. These obligations apply not only to new devices but also to legacy products still on the EU market.
For small and medium-sized manufacturers, PMS implementation may seem burdensome—but non-compliance carries greater risk. Investing in a structured PMS framework is a regulatory necessity and a business advantage supporting safer, more innovative products.
Recommendations for Manufacturers
To ensure alignment with regulatory expectations, manufacturers are advised to:
- Embed PMS into their QMS in a structured, traceable manner;
- Apply PMS obligations to all marketed devices, including legacy and Class I devices;
- Define roles and responsibilities clearly, especially for data analysis and reporting;
- Update PMS and PSURs regularly based on real-world data and product performance;
- Seek expert support to navigate complex MDR/IVDR requirements;
- Stay up to date with EU guidance and national authority communications.
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Source:
Inspectie Gezondheidszorg en Jeugd (IGJ). Oproep aan fabrikanten van medische hulpmiddelen: zorg voor een goed PMS-systeem. October 2024.
https://www.igj.nl