01

Show how requirements are met

The technical documentation must explain the relevant design, manufacture and operation, using the content prescribed by the product legislation. Connect the product definition and use limits with drawings, risk analysis, technical solutions, tests or calculations, labels and instructions. An identical folder checklist cannot address every product’s risks.

02

Check the scope of each report

Compare sample identity, model, version and conditions with the marketed product. Assess changes rather than automatically transferring another model’s results. Record partial standards application and alternative solutions. Missing evidence remains an open requirement even when the report cover uses broad conformity wording.

03

Issue and maintain the correct declaration

The EU declaration states conformity under the manufacturer’s responsibility. Check product identity, applicable acts, relevant technical references, authorised signature and any necessary body/procedure information. A consultancy letter, report or body certificate does not replace the required declaration. Some product families use different outputs, so check the applicable rules. Link subsequent design changes, evidence and declaration versions. Kayra supports document organisation; manufacturer responsibility and any body’s assessment role remain distinct.

Official sources

Reviewed: 3 October 2026. Check the current rules and assessment route for the actual product.