You manufacture PPE, or have it manufactured.
Anyone placing PPE on the market under their own name or brand carries full responsibility for its conformity. Article 8 of Regulation (EU) 2016/425 sets out what that means in practice.
You do not produce yourself. Are you still the manufacturer?
As a rule, yes. Article 3(4) states expressly that a manufacturer is also anyone who has PPE designed or manufactured and markets it under their own name or brand. Whoever sets the specification and has production carried out abroad holds the manufacturer's obligations, not the production site.
The production site then appears in the technical documentation and on the certificate, not on the product. What appears there is one address, yours. The situation is different when you buy in a fully developed product: the distinction in detail.
Your obligations at a glance
The order follows the text of the Regulation so that you can look up every point there.
- Design and manufacture in conformity
The PPE must meet the essential health and safety requirements of Annex II, starting at the design stage.
- Technical documentation and conformity assessment
Draw up the documentation under Annex III and carry out, or have carried out, the procedure under Article 19. Then issue the EU declaration of conformity and affix the CE marking.
- Keep records for ten years
Keep the technical documentation and the declaration of conformity for ten years from the date the PPE was placed on the market.
- Ensure conformity of series production
Use suitable procedures to ensure that series production remains in conformity. Changes to the design or to the standards relied upon have to be taken into account.
- Traceability
Apply a type, batch or serial number to the PPE, or for small products to the packaging or the accompanying documents.
- Identification of the manufacturer
Name, registered trade name or trade mark, and a postal address at which you can be contacted. A single point of contact, in language that is easily understood.
- Instructions and information
Supply the instructions and information under Annex II, point 1.4, in a language easily understood by end users in the member state concerned.
- 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.
It rarely fails on the product
In eight years of testing, the cause of delays was almost never the design. It was a wrong classification right at the start, or technical documentation missing one point from Annex III. The dossier then comes back, and every round costs weeks.
How these obligations can be met
Each item bookable on its own. Prices on request after the initial call.
Conformity check
Category, procedure and relevant standards set out in writing, with a cost estimate and a timeline.
Technical documentation
Built up or checked against Annex III before the documentation goes to the notified body.
Preparation of the type-examination
Choice of notified body, scope of testing, sample selection and support through every round of queries.
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.