Checklist for CE marking compliance

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

Before affixing the CE marking to a product, verify: (1) identify all applicable EU directives and regulations for the product; (2) determine the applicable conformity assessment module(s); (3) identify the applicable harmonised standards and verify that the product meets the essential requirements; (4) engage a notified body where required by the applicable legislation; (5) compile the technical documentation (design files, risk assessment, test reports, calculations); (6) carry out or commission the required testing; (7) draw up the EU Declaration of Conformity listing all applicable legislation; (8) affix the CE marking (and the notified body's identification number where applicable); (9) ensure the manufacturer's name and address appear on the product; (10) set up post-market surveillance procedures.

Common compliance gaps include: missing or incomplete technical documentation, failure to update the file when the product is modified, applying harmonised standards that have been superseded, omitting one of several applicable directives from the DoC, and failure to appoint an EU-established responsible person for non-EU manufacturers.

Why it matters for international businesses

For manufacturers and importers, a pre-market compliance check is far cheaper than an enforcement action. MAAK Advocaten and its network of technical experts provide integrated legal and technical compliance assessments.