Obligations for importers and Distributors

It’s now the responsibility of importers and distributors to ensure compliance on all PPE products. Before, only manufacturers and authorised representatives had to take this on.

Obligations for importers

Four key duties have been introduced for those who import PPE products. These have added a much-needed level of additional due care and diligence. The role of importer now includes:

Only placing compliant PPE on the general market.

Guaranteeing the product has all the correct documentation available.

(we’ll discuss this in more detail later)

Showing a product ID and postal address where someone can be contacted.

Ensuring the transport and storage processes do not in any way jeopardise the condition of the products in question.

Obligations for distributors

Similarly, there are now four areas where distributors will also need to take matters into their own hands. There is some crossover with the requirements of importers. Distributors need to:

Act with due care whenever they are handling PPE products.

Verify all products have the correct markings and are accompanied by verifiable documentation.

Make sure no PPE is made available in a market if the products in question do not meet the standards required.

Again, make sure during all stages of transport and storage that the condition of the product doesn’t become compromised.

Required documents

Documentation is needed to ensure the right steps are taken by both importers and distributors. The primary documents you’ll need include: 

A copy of the Manufacturers Module B EU Type Examination Certificate and (if applicable) a copy of the Module C or D certificate.

A declaration of conformity for the product you’re handling.

User instructions which are written in the correct language.

Records which stretch as far back as 10 years.

Ultimately, the 2016/425 changes have been brought in to spread the weight of responsibility further. However, there are always exceptions to the rule.

Exemptions to 2016/425

In some cases, the new legislation won’t apply. If any of the following relates to a PPE product which is being shipped, the new rules placed on importers and distributors do not come into effect: