CERTIFICATION & COMPLIANCE GUIDE

Choose CE support: competence, deliverables and independent roles

Compare a consultancy’s proposed work with the product’s actual technical needs and required independent assessment.

Specify the assignment before comparing providers

Give prospective advisers the product description, intended use, variants, target market and current evidence. Ask what they will deliver: applicability review, risk-analysis facilitation, technical-file organisation, laboratory coordination or declaration preparation. A quotation should identify the responsible technical specialists and the work that is excluded, rather than promise one universal CE certificate.

Separate advisory competence from laboratory competence and notified-body designation. If a body is required, its appointment must cover the applicable legislation, product and task. A consultant’s relationship with a laboratory does not transfer that designation. Ask who contracts with each party and who retains the original reports, decisions and editable technical records.

A hypothetical bundled offer

A provider offers a fixed-price package including an unnamed test laboratory, a “CE licence” and all future model changes. The manufacturer has three variants and no approved design baseline. Ask for the assessment basis, sample assumptions, report ownership, excluded retests and identity of any required body. The price cannot establish that the scope is adequate.

Compare offers against the same controlled variant list. Refuse a deliverable whose wording suggests that advisory approval replaces the manufacturer’s responsibility or a required independent decision. The next action is to settle scope and evidence gaps, then commission clearly separated advisory, test and independent assessment work where applicable.

Contract and handover checks

Agree confidentiality, access to supplier evidence, technical-query escalation and change handling. Specify which draft documents need manufacturer approval and how unresolved safety issues will be recorded. A file handover should include revision history and the basis of any accepted evidence, so the manufacturer can maintain it after the consultancy assignment ends.

Kayra’s proposed support must be described as preparation and coordination within an agreed advisory scope. No verified notification or universal approval status is inferred from the company name. The manufacturer signs through an authorised person, while a required independent body evaluates its own criteria without a promised positive outcome.

Official sources

Related product guides

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The records needed to compare CE support deliverables and independent roles depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.

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