What is post-market surveillance under EU product law?

Dutch term: Post-market surveillance | Legal basis: Regulation (EU) 2019/1020 + GPSR

Post-market surveillance (PMS) is the obligation of manufacturers and importers to systematically monitor products already placed on the EU market for safety and compliance issues. Under Regulation (EU) 2019/1020 and the GPSR, manufacturers must collect user feedback, monitor incidents, track regulatory developments, cooperate with authorities and take corrective action where non-compliance or safety issues emerge.

PMS obligations are ongoing for the lifetime of the product on the market. For higher-risk products, sector-specific legislation may require specific PMS plans, periodic safety update reports and proactive vigilance systems. Market surveillance authorities (NVWA, RDI) can request evidence of PMS activities during inspections, and failure to maintain adequate PMS can be an aggravating factor in enforcement actions.

Why it matters for international businesses

For manufacturers and importers, PMS is no longer a passive obligation. The GPSR and Regulation 2019/1020 require documented, proactive monitoring systems. MAAK Advocaten advises on structuring PMS programmes that satisfy regulatory requirements while remaining operationally manageable.