What is product certification under EU law?

Dutch term: Productcertificering | Legal basis: Decision 768/2008/EC + sector-specific legislation

Product certification under EU law refers to the process by which a manufacturer demonstrates that its product meets the applicable essential requirements through a defined conformity assessment procedure. The procedure varies by product category and risk level, ranging from manufacturer self-assessment (module A) through type-examination by a notified body (module B) to full quality assurance with continuous notified body oversight (module H).

The conformity assessment modules are standardised in Decision 768/2008/EC (the New Legislative Framework decision) and are referenced by each sector-specific directive and regulation. The result of a successful conformity assessment is the right to affix the CE marking and to draw up the EU Declaration of Conformity. For products requiring notified body involvement, the certificate issued by the notified body is a prerequisite for CE marking.

Why it matters for international businesses

For manufacturers entering the EU market, choosing the right conformity assessment route and, where required, the right notified body are strategic decisions that affect both the time to market and the ongoing compliance cost.