Determine Scope
Identify which EU directives/regulations apply (LVD, EMC, RoHS, RED, MDR, Toy Safety, Machinery). Map harmonized standards to your product and confirm which require a Notified Body versus self-declaration.
Testing & Assessment
Plan lab tests aligned to the applicable standards. Use pre-compliance tests during development to avoid failures later. If a Notified Body is required, engage early and agree on sample counts, timelines, and report format.
Documentation
Assemble a Technical File: design drawings, BOM, risk assessment, test reports, user manuals, labeling proofs, and production controls. Draft the Declaration of Conformity (DoC) with manufacturer/importer details, directives, standards, and signature.
Labeling & Ongoing Control
Apply the CE mark with correct proportions and visibility. Include importer contact, serial/lot number, and any required warnings. Maintain change control: retest if materials, firmware, or critical suppliers change. Keep documents for at least 10 years.