Glossary›Registered importer
Registered importer
Whoever first places a medical device from a country outside the EU on the European market is an importer under the MDR and carries obligations of their own. The same applies in Switzerland under the MepV.
What it means
The importer checks that the product carries a CE mark and a declaration of conformity, that the manufacturer has named an authorised representative in the EU and that the UDI labelling is complete. The importer puts their name and address on the product or its accompanying documents, registers in EUDAMED and keeps a register of complaints, recalls and non-conforming products.
Storage and transport must not impair the product. If the importer identifies a risk, they inform the manufacturer and the authorities.
Why it matters in procurement
Without an importer, a product from a third country may not be used in a healthcare facility. For procurement, the importer is the party that takes responsibility for the product on the market and provides the evidence.
How SANOVIO works with it
SANOVIO takes on the role of the importer for goods from sourcing: checks, labelling, registration, traceability. The QA team releases every batch before it ships.