The CE mark tells regulators and customers in the European Economic Area that a product meets the applicable EU health, safety and environmental requirements. For many product categories — general machinery, low-voltage electrical equipment, most toys, many construction products — manufacturers can self-declare conformity (often called Module A / internal production control) rather than involve a notified body. That's a real cost and time saving, but it puts the compliance burden squarely on you, and the evidence has to hold up if a market-surveillance authority asks for it.
Step 1 — Identify the applicable directives and standards
Every CE-marked product falls under one or more EU directives or regulations (e.g. Machinery Directive, Low Voltage Directive, EMC Directive, RoHS) — and each directive points to harmonised standards that, if followed, create a "presumption of conformity." Get this step wrong and everything downstream is built on the wrong foundation.
Example: a bench-top electrical tool typically falls under the Machinery Directive, the Low Voltage Directive, the EMC Directive, and RoHS for hazardous substances.
Step 2 — Determine the conformity assessment route
Confirm the product genuinely qualifies for self-declaration under the relevant directive(s) — some product/risk combinations require a notified body regardless of your preference. Read the directive's conformity-assessment-procedure annex, not just the marketing summary.
Step 3 — Carry out the risk/hazard assessment
Identify the hazards the product could present and show how the design meets the essential health and safety requirements (EHSRs) of the applicable directive(s) — this is the technical backbone of your file, not a formality.
Step 4 — Test against the harmonised standards
Test (in-house or via an accredited lab) against the relevant harmonised standards, or otherwise demonstrate compliance with the EHSRs directly. Keep every test report — it's core technical-file evidence.
Step 5 — Assemble the technical file
The technical file is what you'd hand to a market-surveillance authority on request. It typically includes: a general product description, design/manufacturing drawings, the risk assessment, test reports, the list of standards applied, and user instructions/labeling. It doesn't get submitted anywhere by default — but it must exist and be retrievable, usually for 10 years after the last unit is placed on the market.
Common gap: technical files that were complete at launch but never updated after a design change, a new supplier component, or a standard revision — leaving a mismatch between what's documented and what's actually shipping.
Step 6 — Write the Declaration of Conformity (DoC)
The DoC is a formal statement — manufacturer details, product identification, the directives and standards claimed, and a signature — that you take full responsibility for the product's conformity. It's a distinct document from the technical file, and it's what typically travels with the product or is made available to the customer.
Step 7 — Apply the CE mark and sign off
Affix the CE mark to the product (or packaging/documentation where physical marking isn't practical) once the DoC is signed. Increasingly, a compliant electronic signature — re-authentication plus a stated reason for signing, recorded in an audit trail — is used for this sign-off, so there's no ambiguity later about who approved the declaration and when.
Keeping it maintained, not just launched
CE conformity isn't a one-time event — every design change, new variant, or supplier substitution can require re-assessment. Linking CE tracking directly to the product record you already maintain (rather than a parallel spreadsheet) is what keeps the technical file and the DoC honest over the product's life, not just at launch.
See CE Marking Software in ISOXPERT Compliance360 →