What we assess
PLANCK maps product characteristics against the scope of EU legislation and helps prepare the technical file, testing brief and questions for the manufacturer. We review the completeness of instructions, marking and component records. Where the selected procedure requires a notified body, we coordinate with a body whose designation covers the relevant work. CE applies only to product categories covered by the relevant EU legislation; there is no universal CE certificate for every product. The manufacturer remains responsible for conformity and the required declaration. For series production, we also address design changes and updating evidence when components are replaced.
What to prepare
- Product description and intended use
- drawings and specifications
- component list
- existing test reports
- instructions
- manufacturer and destination market details
What you receive
An agreed conformity assessment route, a list of missing evidence and a dossier for the selected procedure. Timing and costs follow the product review, testing needs and any notified body involvement.
Sources & regulatory basis
Regulatory basis checked:
Timing & cost
Quoted after reviewing models, manufacturers, testing scope, site visits and translation needs. The proposal separates the stages and their deliverables.