Importer
Importer is defined under MDR (EU) 2017/745 Art. 2(33) as any person established in the EEA who places a medical device from a third country on the EU market. The importer stands between the (non-EU) manufacturer and the distributor or end user.
Importer obligations under MDR Art. 13:
1. Verify that the manufacturer has carried out the conformity assessment
2. Check that CE marking and EU Declaration of Conformity are in place
3. Verify that technical documentation and instructions for use are available
4. Indicate their own name and address on the product or packaging
5. Maintain appropriate storage and transport conditions
6. Register products in EUDAMED (SRN)
7. Forward vigilance reports to authorities
Liability: if an importer makes substantial modifications to a product or distributes it under their own name, they become the manufacturer and assume all manufacturer obligations.
Distinction from distributor: a distributor does not import from third countries but makes products already placed on the EEA market available to others.
Frequently asked questions
What are the main obligations of an importer under MDR?
The importer must verify that CE marking, EU Declaration of Conformity, and technical documentation are present. They must indicate their own name on the product, ensure correct storage, and forward incident reports. If they make substantial modifications, they become the manufacturer.
What is the difference between an importer and an EU Authorised Representative?
The EU Authorised Representative acts on behalf of the non-EU manufacturer and assumes specific manufacturer obligations. The importer is an independent economic operator who purchases and imports products into the EEA. Both roles may be held by the same entity but need not be.