01

Link the product to the evaluated design

Connect model, serial or batch identifiers with the manufacturing design version and supporting reports. Reusing a CE label does not prove traceability. Contact information, identifiers and user information must follow the applicable product rules; an unchanged label does not settle the effect of a changed component.

02

Keep evidence accessible

Define where drawings, assessment records, reports and declarations are stored and who can supply them to the competent authority. Check the retention period in the applicable legislation. Supplier-held documentation does not remove the manufacturer’s responsibility. Importers and distributors also have product-specific verification, traceability and cooperation duties.

03

Investigate and respond to problems

Record the affected models and batches, risk assessment, findings and measures. Assess necessary corrections, withdrawal, recall or notification under the applicable rules. Commercial agreements cannot erase an operator’s legal role, including when it sells under its own brand. Kayra can support records and documentation updates; market-surveillance powers belong to the competent authority, and consultancy is not authority approval.

Official sources

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