A distributor can move from downstream verification to full manufacturer responsibility through rebranding or substantial modification. Private-label and customisation workflows should therefore include a CRA role-change gate before the product is supplied under the distributor's identity.
Ordinary Distribution Does Not Make the Distributor the Manufacturer
A distributor normally remains within Article 20 when it makes an original-branded product available without affecting its properties. Manufacturer status arises only when the Article 21 conditions are met.
Own Name or Trademark Creates the Role Change
Where the distributor places the product on the market under its own name or trademark, Article 21 treats it as the manufacturer. This can apply to private-label and white-label arrangements even without technical redesign.
Substantial Modification Creates the Same Result
A distributor that carries out a substantial modification of an already marketed product is also considered the manufacturer. The modification assessment should be documented before commercial release.
Article 13 Duties Replace the Narrower Distributor Position
Once Article 21 applies, the operator must be capable of performing the manufacturer duties relating to product cybersecurity, risk assessment, vulnerability handling, technical documentation, support and conformity.
Article 14 Reporting Applies
The new manufacturer role also brings Article 14 reporting obligations, so incident and vulnerability reporting workflows must identify the distributor-manufacturer as the responsible party.
Obtain Technical Evidence Before Private-Label Launch
A distributor cannot perform manufacturer duties effectively if the upstream supplier withholds architecture, testing, vulnerability and conformity evidence. Evidence access should be secured before launch.
Align Product Identity and Declarations
Product labelling, manufacturer information, declarations and conformity records should consistently reflect the distributor's new manufacturer role.
Create a Role-Change Approval Gate
Require CRA review for rebranding, white-label products and major modification projects so sales or procurement teams do not unintentionally trigger manufacturer obligations without operational readiness.
Official sources
Read the full legal text and Commission material for precise wording, qualifications and updates.