An importer is a natural or legal person established within the EU who places PPE from a third country on the EU market.
Legal obligations of importers
- Importers shall place only compliant PPE on the market.
- Before placing a PPE on the market, importers shall ensure that the appropriate conformity assessment procedurehas been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 8(5) and (6). Where an importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not place it on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
- Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
- Importers shall ensure that the PPE is accompanied by the instructions and informatio in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
- Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements.
- When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
- Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
- Importers shall, for 10 years after the PPE has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.
- Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Importer sometimes manufacturer
An importer is considered a manufacturer for the purposes of this Regulation and must meet the same obligations, when he brings PPE on the market under his own name or trade mark or modifies PPE already placed on the market in such a way that compliance with this regulation may be compromised.
For the full text: PPE Regulation (EU) 2016/425.