Post-market surveillance (PMS) is a fundamental requirement under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Manufacturers must actively monitor their devices’ safety and performance post-market to ensure compliance and protect public health. However, recent audits by the Dutch Health and Youth Care Inspectorate (IGJ) reveal non-compliance, emphasising the increasing regulatory scrutiny on PMS practices.
Authority findings on PMS compliance
Since September 2023, IGJ has intensified its PMS audits, focusing on manufacturers’ PMS plan, PMS reports, and Periodic Safety Update Report (PSUR). In addition, the Dutch authority also inspected how PMS processes were integrated within the quality management system (QMS).
According to the findings published by the Dutch authority in October 2024, manufacturers often struggle with understanding the PMS requirements under MDR and IVDR, leading some to exit the market once their legacy status is ended due to cost, complexity, and resource constraints. Smaller manufacturers and those without notified body oversight particularly lack experience, though most recognise that PMS obligations already apply to legacy devices.
Inspections of 13 manufacturers in 2023 and 2024 uncovered consistent deficiencies across various device categories, including Class I medical devices, software applications, and legacy in-vitro diagnostics (IVDs).
The main findings of the inspections are the following:
- Integration with QMS: most manufacturers have indeed linked PMS to their QMS, certified to EN ISO 13485 or ISO 9001.
- PMS documentation: over half of the audited manufacturers lacked clear PMS plans, and many PMS reports or PSURs were incomplete.
- PMS report updates: some manufacturers failed to update reports despite clear necessity.
- Data collection & analysis: many lacked structured data collection, clear data sources, and differentiation between serious and non-serious incidents.
- Structured analysis & actionable outcomes: Few manufacturers defined indicators for corrective action, leading to isolated conclusions.
- Implementation of PMS findings: while corrective actions were recorded, they were not always linked to benefit-risk analyses.
Regulatory impact and industry response
Manufacturers failing to meet PMS requirements face enforcement actions under MDR/IVDR, ranging from warnings to market restrictions. However, IGJ noted that companies prioritising PMS can achieve compliance, as demonstrated in follow-up inspections. A well-implemented PMS system not only ensures regulatory adherence but also drives product innovation and safety improvements.
Actions to take
With regulatory authorities increasing PMS oversight, manufacturers must proactively strengthen their surveillance systems to mitigate compliance risks. Manufacturers shall ensure PMS compliance by:
- Assigning clear responsibilities;
- Integrating PMS into their QMS;
- Applying PMS to all marketed devices;
- Seeking external expertise when needed;
- Staying updated on new EU guidelines.
Those who invest in robust PMS processes will not only avoid penalties but also enhance their competitive position through continuous product development and innovation.
Do you have questions on PMS requirements? Contact us today!
References:
IGJ(2024). Call to Medical Device Manufacturers: Implement Effective PMS System. Retrieved on 13 January 2025.
Georgios Mariolos
Regulatory Intelligence & Innovation
21/02/2025
The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.