Importer and EUDAMED: when to register vs distributor

A frequent pattern: a PL company resells an EU device and calls itself an “importer” in email, while the contract says national distributor. That label in Actor hurts later — corrections and delay.

Why companies get this wrong

In “non-EU manufacturer → someone in PL → hospital / distributor” chains, everyone gets labelled “importer”. In EUDAMED and MDR, roles have specific meaning. Wrong Actor role = corrections and delay.

Practical role-map questions

• Who places the device on the EU market first?
• Is there an Authorized Representative?
• Does the PL entity truly import, or only resell nationally?
• Do contracts describe roles the same way as EUDAMED data?

Common mistakes

• National distributor registered as importer “just in case”
• Label / IFU inconsistency vs database role
• Assuming EUDAMED alone covers all importer duties outside the database

Non-EU entry: Gate to EU. Actor/UDI registration: EUDAMED Express.