
CE self-assessment: manufacturer evidence and declaration responsibility
Use a permitted manufacturer assessment route with real evidence; self-declaration is not exemption from assessment.
Establish whether the route permits manufacturer assessment
Self-declaration describes the manufacturer’s responsibility, not permission to bypass product requirements. First identify the applicable law and whether its procedure permits assessment without a notified body. If independent involvement is required, a signed statement alone cannot replace it. Keep the procedure choice traceable to the actual product classification.
Even without a notified body, the manufacturer needs appropriate technical evidence, risk assessment, production controls and a legally relevant declaration. A purchased template cannot show that requirements have been met. Assign competent people to review the evidence and authorise signing, while keeping unresolved technical questions open until properly addressed.
A hypothetical supplier’s one-page statement
A company sells under its own brand and receives a supplier letter saying “self-certified CE” without model identity or supporting evidence. Ask for the actual configuration, applicable requirements, assessment basis and test or design records. The letter’s signature does not establish that the company can support its own finished-product conformity claim.
The next action is to establish whether self-assessment is legally available and obtain evidence for the actual branded product. Where information is missing, record the gap and secure competent review or testing. Do not create a confident declaration by replacing the supplier’s name with the brand owner’s name in the same letter.
Signing and continuing control
The authorised signatory must be able to rely on a completed and controlled evidence file. Record the legal acts, exact models and applicable standards or other technical means with appropriate specificity. Maintain the file and evaluate later changes; self-assessment does not end the manufacturer’s continuing responsibility for the produced configuration.
Kayra may assist evidence organisation and declaration preparation. It does not provide a substitute manufacturer signature or guarantee that self-assessment is suitable for every product. Independent laboratory work can support the file where appropriate, while any legally required notified-body task must still be completed separately.
Related product guides
- ← Return to the main document guide
- 01How to Obtain CEOpen guide →
- 02Who Manages the CE Process?Open guide →
- 03CE Certification and Consultancy ProviderOpen guide →
- 04Documents and Records Required for CEOpen guide →
- 05CE Cost and TimescaleOpen guide →
- 06CE Enquiry and ValidityOpen guide →
- 07CE Renewal and SurveillanceOpen guide →
- 08CE Audit ProcessOpen guide →
- 09Is CE Mandatory? Requirements ExplainedOpen guide →
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The records needed to establish the manufacturer’s self-assessment basis depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.