You bring PPE from a third country into the Union.
Importers may only place conforming PPE on the market. Article 10 of Regulation (EU) 2016/425 requires you to verify the manufacturer's work before the goods are sold. An existing CE marking is not sufficient.
Importer or manufacturer? The brand decides.
You remain an importer as long as you place the product on the market under the manufacturer's name and brand. As soon as you sell it under your own brand, or modify a product already placed on the market in a way that may affect its conformity, Article 12 makes you the manufacturer, with every obligation under Article 8.
This matters in practice because the manufacturer is often based in a third country and is difficult to pursue in legal terms. As the importer you are the operator established in the Union and therefore the first point of contact for market surveillance and for injured parties. See also the manufacturer's side of the distinction.
Your obligations at a glance
The order follows the text of the Regulation so that you can look up every point there.
- Place only conforming PPE on the market
The basic rule of Article 10(1), and the one from which everything else follows.
- Verify the manufacturer's work
Satisfy yourself that the conformity assessment procedure under Article 19 has been carried out, that the technical documentation exists, that the CE marking has been affixed and that the required documents are supplied.
- Your own name and address on the product
Name, registered trade name or trade mark and a postal address, on the PPE itself or, where that is not possible, on the packaging or accompanying documents.
- Instructions and information
Ensure that the instructions and information under Annex II, point 1.4, are supplied in a language easily understood by end users in the member state concerned.
- Storage and transport
While the PPE is under your responsibility, make sure that storage or transport conditions do not jeopardise its conformity.
- Sample testing and complaints register
Where appropriate in view of the risks, carry out sample testing of PPE made available on the market, investigate complaints and recalls, keep a register and keep distributors informed.
- Corrective measures and authorities
Where non-conformity is suspected, take corrective measures without delay, withdraw or recall the product where necessary, and inform the authorities.
- Keep records for ten years
Keep a copy of the EU declaration of conformity available for ten years and be able to produce the technical documentation on request.
A certificate is not proof that it fits
Certificates from third countries frequently refer to a different product version, a withdrawn standard or a body that is not notified for this product at all. Checking that takes an hour. Not checking it costs the consignment.
How these obligations can be met
Each item bookable on its own. Prices on request after the initial call.
Supplier check
Review of certificates, test reports and technical documentation of your supplier before the order is placed.
Sourcing and manufacturer coordination
Assessment of the production site, comparison of specifications and existing certificates, ongoing coordination.
Marking and instructions
Checking marking, user information and language versions for the target markets.
Role clarification under Article 12
Whether your own-brand business turns you into the manufacturer, and what follows from that.
Holding several roles at once is the normal case.
Four questions to establish which role applies to you.A conversation costs you 30 minutes.
Describe your product and your role. Afterwards you will know which obligations actually apply to you and where the pitfalls are. No obligation.