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Personal protective equipment - What role do you have?

Since April 21, 2018, Directive 89/686/EEC has been replaced by Regulation (EU) 2016/425 on personal protective equipment (PPE). One of the main changes in the new regulation is that it clearly describes the roles and obligations of all operators in the supply chain.

Market participants

The different roles in the supply and distribution chain are defined in Regulation (EU) 2016/425 as follows:

  • Manufacturer: A natural or legal person who manufactures PPE, has it designed or manufactured and markets it under his name or trademark.
  • Authorized representative: a natural or legal person established in the Union who is authorized in writing by a manufacturer to perform specific tasks on its behalf.
  • Importer: A natural or legal person established in the Union who places PPE from a third country on the Union market.
  • Distributor: A natural or legal person in the supply chain, different from the manufacturer or importer, who offers PPE on the market.

Importance of trade name or trademark

Manufacturers of personal protective equipment are logically best informed about the details of the design and manufacturing process. Regulation (EU) 2016/425 therefore states that the obligation to carry out conformity assessment lies solely with the manufacturer. In some cases, this responsibility lies with the importer or distributor. For example, if the PPE is sold under its own brand name or the design is changed in such a way that conformity with the regulation is compromised. In these cases, that party is considered the manufacturer and must assume all associated obligations.

Do you fulfill the role of personal protective equipment manufacturer? If so, you are responsible for the following:

  • Ensure that the PPE is designed and manufactured in accordance with essential health and safety requirements 2;
  • Drafting the technical documentation (Annex III of Regulation (EU) 2016/425) and carrying out the relevant conformity assessment procedure 2;
  • Preparing the EU declaration of conformity and providing it with the product or making it available online 3;
  • Applying the CE mark to the personal protective equipment 4;
  • Ensure that the PPE is accompanied by the instructions for use and mandatory data as stated in Regulation (EU) 2016/425 5;
  • Keeping the technical documentation and EU declaration of conformity for 10 years 6;
  • Provide information and documentation, if requested by a competent national authority 7;
  • Taking corrective action, if there is a suspicion of non-conformity of the product 8;
  • 9. Notifying all concerned economic operators and national authorities of Member States when a non-conformity has been found.

Need support?

Agents, importers and distributors also have specific obligations regarding conformity assurance of PPE. Do you sell PPE on the European market and wonder what role you have and what obligations are involved? Précon can offer you support on:

  • Establishing your role as a market participant.
  • Understanding your obligations.

Contact us at +31 (0)30 - 65 66 010 or info@precongroup.com. You will then receive our no-obligation quotation.

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