EUDAMED for Importers: Manufacturers Still Need a Separate Actor

If you already have a manufacturer Actor in EUDAMED and you also import medical devices from outside the EU, that manufacturer SRN is not enough. EUDAMED issues a separate Actor ID / SRN for each role.

Why this matters for importers

EUDAMED is the EU database for medical devices under MDR (EU) 2017/745 and IVDR (EU) 2017/746. Actor registration has been mandatory since 28 May 2026 — see Mandatory EUDAMED Use from 2026.

An importer is the EU-established operator that first places a device from a third country on the Union market. That includes EU manufacturers who also bring in sister-company or OEM devices from outside the EU. Importing is a regulatory role: you must verify CE marking, UDI, and manufacturer/authorised representative registration, and identify yourself on the device or accompanying information.

One role, one Actor

The Commission's Actor FAQ is clear: the same company can hold more than one role, but each role needs its own registration. Manufacturer (XX-MF-……) and importer (XX-IM-……) are two Actors, even if the name, address, and VAT are identical.

Align the importer role with your national filings too — in Greece, EOF / GreMDIS.

How we can help

QC Analytics supports Actor and device registration in EUDAMED, EOF / GreMDIS, and UDI/GS1 — including a second importer Actor next to an existing manufacturer record.

See EOF, EUDAMED, GS1 or contact us.