You make PPE available on the market.
Even without being the manufacturer or the importer, you have verification duties. Article 11 of Regulation (EU) 2016/425 requires due care, and it requires it before the product is made available.
Your obligations at a glance
The order follows the text of the Regulation so that you can look up every point there.
- Due care
Act with due care in relation to the requirements of the Regulation when making PPE available on the market.
- Verification before making available
Check that the CE marking has been affixed, that the required documents and the instructions under Annex II, point 1.4, are supplied in the language of the member state concerned, and that the manufacturer and importer have met their marking obligations.
- Storage and transport
While the PPE is under your responsibility, storage and transport must not jeopardise its conformity.
- Corrective measures
Where conformity is in doubt, stop making the product available, arrange corrective measures and, where there is a risk, inform the authorities without delay.
- Information on request
On reasoned request, provide all information and documentation needed to demonstrate conformity and cooperate with the authorities.
The check belongs before the sale
The duty applies before the goods go on sale, not once an objection arrives. In practice the instructions in the local language are often missing, or the importer's address appears nowhere. Both are immediately visible during an inspection. Anyone also selling under their own brand becomes the manufacturer under Article 12.
How these obligations can be met
Each item bookable on its own. Prices on request after the initial call.
Incoming goods check
A checklist for the inspection before making the product available, tailored to your range.
Role clarification under Article 12
Whether an own brand or a product modification turns you into the manufacturer.
Training
Training purchasing and quality assurance on the verification duties, by video call.
Second opinion in a crisis
Support with objections raised by market surveillance.
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.