What is product conformity under EU law?

Dutch term: Productconformiteit (EU) | Legal basis: Various EU product directives + GPSR

Product conformity under EU law means that a product meets all applicable essential requirements set by the relevant EU harmonised legislation (directives and regulations). Conformity is demonstrated through the conformity assessment procedure specified for the product category, documented in the technical file, and declared in the EU declaration of conformity. The CE marking is affixed as the visible indicator of conformity.

The conformity assessment procedure varies by product and risk level, ranging from self-assessment by the manufacturer (module A) to full quality assurance with third-party oversight (module H). For higher-risk products, involvement of a notified body is mandatory. The manufacturer bears primary responsibility for conformity, but importers and distributors have verification obligations under Regulation (EU) 2019/1020.

Why it matters for international businesses

For manufacturers and importers placing products on the EU market through the Netherlands, demonstrating and maintaining product conformity is the legal prerequisite for market access. Non-conformity can result in enforcement actions, recalls, fines and product liability claims.