A manufacturer is a natural or legal person who manufactures Personal Protective Equipment (PPE) or has it designed or manufactured and markets it under his name or trademark.
The authorised representative is a natural or legal person established within the EU who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks.
Legal obligations of manufacturers
- The manufacturer shall ensure that PPE placed on the market are designed and manufactured in accordance with the essential health and safety requirements.
- The manufacturer draws up the technical documentation and carries out the relevant conformity assessment procedure or has it carried out (for category II or III products). If compliance with the applicable essential health and safety requirements has been demonstrated by this procedure, the manufacturer draws up an EU declaration of conformity and affixes the CE marking.
- The manufacturer shall keep the technical documentation and the declaration of conformity for a period of at least 10 years.
- The manufacturer shall ensure that procedures are in place to ensure the continued conformity of series production. Those procedures shall also take account of changes in the design or characteristics of the PPE and of changes in harmonised standards or other technical specifications by reference to which conformity of the PPE is declared. The manufacturer shall, at his request, carry out sample testing of his products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and of recalls, and shall keep distributors informed of such monitoring.
- The manufacturer shall ensure that the PPE he places on the market bears a type, batch or serial number or any other element allowing its identification.
- The manufacturer shall indicate the name, registered trade name or registered trade mark and the postal address on the PPE or, if not possible, on its packaging or on a document accompanying it.
- The manufacturer shall ensure that the PPE is provided with user instructions in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
- The manufacturer shall either provide the EU declaration of conformity with the PPE or include it in the user instructions or provide an internet address at which the declaration of conformity can be accessed.
- Where the manufacturer considers or has reason to believe that a PPE which it has placed on the market is not in conformity with this Regulation, it shall immediately take corrective action or withdraw it from the market if necessary. Furthermore, where the PPE presents a risk, the manufacturer shall immediately inform the competent national authority.
- The manufacturer shall, at the request of the competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the PPE with this Regulation, and shall cooperate with it in any action taken to eliminate the risks posed by PPE which it has placed on the market.