Importing medical devices from outside the EU: the extra obligations under article 13

Buying medical devices from a supplier in China, the UK, Turkey or the US works out cheaper — and it makes you, in the eyes of the MDR, an importer: the first company to place that product on the EU market. Article 13 adds duties that a plain distributor doesn't carry. There are four of them, and it's worth having them written down before your first order.

1. The manufacturer must have an authorised representative in the EU

Without a designated European authorised representative, that manufacturer has no legal way onto the EU market — and you shouldn't be importing from them either. It's the first check, and it's a dealbreaker.

2. Your name, on the product

The importer's name and address — that is, yours — must appear on the product, on its packaging, or on a document that travels with it. That extra labelling is your responsibility, not a favour from the manufacturer.

3. A filed copy of the declaration of conformity

You have to keep a copy of the EU declaration of conformity and be able to locate it for the required period. "The manufacturer has it" doesn't cover you: the obligation to have it available is yours.

4. Registering as an economic operator

The importer is a registered economic operator: your status has to be on record in the relevant system. Check it before someone else does.

In Dossalis, it's one switch

When you set up your company you tick "I also import" and the checklist grows on its own: the four points from article 13 get added to the six from article 14, per product and supplier, each with its verification date. The leading international SaaS tool does this in English, from €199/month, depending on your manufacturer uploading their paperwork to its platform; we do it in Spanish, from €89, with your own verifications as the source.