Limits of liability of the equipment manufacturer for CE marking issues
- A manufacturer is a person who is responsible for the design and production of a product with the aim of supplying the product to the EU market under his own brand name.
- From the perspective of CE marking, it is not important whether the person himself designs, manufactures, assembles, packs, marks the product, or subcontractors do it for him.
- It is the manufacturer's responsibility to ensure that the product is designed and manufactured in compliance with the relevant EU directives/regulations. A technical file for the product must be created, including all the necessary documentation and the conformity assessment procedure.
Other responsibilities of the manufacturer:
- Storage of technical records;
- Ensuring production conditions;
- The identification procedure is followed, product traceability is maintained;
- Identification of all necessary information (manufacturer, date of manufacture, contact details, etc.);
- Provision of appropriate instructions for use, providing information to the user in a language he understands;
- Have procedures in place in case of equipment non-conformity or failure;
If necessary, provide information proving the conformity of the product to national authorities and control bodies.
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