Importer or distributor: EUDAMED registration
How to map economic operator roles in a typical PL supply chain — before you fill Actor.
Informational material, not legal advice or a review of a specific distribution agreement.
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.
© 2026 AZ Regulatory · Alicja Załanowska. Informational material — not a notified body or authority.