Does the product need CE marking?
First identify the product, its intended use and the EU legislation that covers it. An AI component does not, by itself, mean that every software product needs a CE mark. Connected equipment, machinery and other regulated products can have several applicable requirements.
The EU’s CE marking guidance explains that the manufacturer is responsible for conformity. There is no central EU office that issues permission to use the mark.
A practical preparation sequence
- Record the applicable product legislation and the responsible manufacturer or provider.
- Determine the conformity assessment route. Some routes require a notified body; others allow assessment by the manufacturer.
- Assess risks and collect the technical evidence required for that product, including relevant testing.
- Prepare technical documentation and the EU declaration of conformity.
- Apply the CE mark only after the applicable requirements have been met. Maintain records for the period required by the relevant legislation.
Check the AI Act separately
The AI Act is now adopted legislation. Obligations depend on the system’s role, risk classification and applicable transition dates. Use the European Commission’s current implementation guidance alongside the relevant legal text.
Before planning a release, agree the classification and evidence required with qualified product-compliance specialists. CE marking does not establish compliance with every law that may affect the organisation or its data processing.
