The definition is the same across the Market Surveillance Regulation, the General Product Safety Regulation and the New Legislative Framework: a manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark. The decisive element is the brand, not the factory. A company that has goods made by a contract manufacturer and sells them under its own name is the manufacturer, with every obligation that follows.
Article R2 of Decision No 768/2008/EC, reproduced in each product act, lists those obligations: design and manufacture in accordance with the requirements, draw up the technical documentation, carry out the conformity assessment, draw up the EU declaration of conformity and affix the CE marking, keep the documentation for the required period, ensure series production stays in conformity, mark the product with a type, batch or serial number and with the manufacturer’s name and contact address, provide instructions and safety information in the required language, take corrective action, withdraw or recall products that are not in conformity, inform the authorities where a product presents a risk, and cooperate with them.
Article 9 of the General Product Safety Regulation applies a parallel list to consumer products outside harmonisation legislation, adding an internal risk analysis and, through the Safety Business Gateway, the duty to notify accidents. A manufacturer established outside the EU must also ensure that a responsible person exists in the Union before the product is placed on the market.