EUDAMED Registration Obligations by Economic Operator Type

EUDAMED: still rolling out, but the obligations are real

EUDAMED — the European database for medical devices — was originally intended to be fully operational by 2020. It is not. The rollout has been phased, with individual modules coming online at different points, and some modules are still mandatory only from specific dates tied to the broader MDR transition. Despite the delays, EUDAMED is real and the registration obligations it creates are active for manufacturers who already have CE-marked devices under MDR.

One thing that tends to catch teams off guard: EUDAMED is not just a manufacturer database. The registration obligations extend to Authorised Representatives, importers, and distributors. Each economic operator type has different obligations, and confusing them — or assuming that only the manufacturer needs to do anything — is a common source of compliance gaps.

Manufacturers

Manufacturers are the primary actor in EUDAMED. Their obligations include:

Actor registration (Module 1 — ACTOR): Every manufacturer placing devices on the EU market must register as an actor in EUDAMED and obtain a Single Registration Number (SRN). The SRN is what links all the manufacturer's device registrations together. Without an SRN, a manufacturer cannot complete their other EUDAMED obligations.

Device registration (Module 2 — UDI/Device): Manufacturers must register their devices and assign UDIs (Unique Device Identifiers) in EUDAMED. The UDI system has two levels: UDI-DI (device identifier — identifies the specific version/model) and UDI-PI (production identifier — identifies the specific unit/lot). The UDI-DI is what gets registered in EUDAMED's UDI database.

For Class I devices, basic UDI-DI registration is required. For Class IIa, IIb, and III devices, additional device information must be registered, and the device must be linked to a Notified Body certificate.

Notified Body certificates (Module 3 — CERT): While Notified Bodies are responsible for uploading certificates, manufacturers need to verify that their certificates are correctly linked to their EUDAMED account.

Clinical investigations (Module 4 — CLINICAL): If you conduct clinical investigations under MDR Article 62, registration and reporting obligations apply through this module.

Vigilance and PMS (Module 5 — VIGILANCE): Serious incident reports and trend reports are submitted through this module. For Class IIb and III manufacturers, PSURs must also be uploaded here. This is the module that connects EUDAMED most directly to ongoing PMS obligations.

Market surveillance (Module 6): This module is primarily used by competent authorities but manufacturers may interact with it in the context of FSCAs and FSNs.

Authorised Representatives

An Authorised Representative (AR) is an EU-established entity appointed by a manufacturer outside the EU to act on their behalf. The AR's EUDAMED obligations are substantial:

The AR must register as an actor in EUDAMED and obtain their own SRN. The manufacturer's devices are then registered under the AR's SRN in addition to (or in some configurations, instead of) the manufacturer's own registration. This is a nuanced area — the exact registration structure depends on how the AR-manufacturer relationship is configured and whether the manufacturer has their own EUDAMED account.

The AR carries the vigilance reporting obligations in EUDAMED for the devices they represent. This means the AR must be operationally integrated into the manufacturer's incident reporting process — not just a named contact on a piece of paper. If an incident occurs and the AR isn't set up to report in EUDAMED, the timelines will be missed.

Importers

Importers — EU-based entities that place devices from non-EU manufacturers onto the EU market under their own name — have lighter EUDAMED obligations than manufacturers or ARs but are still required to register.

Importers must register as actors in EUDAMED (Module 1) and obtain an SRN. Their main EUDAMED role is self-identification as an economic operator for the devices they handle. Importers are not typically responsible for device registration (that's the manufacturer's or AR's responsibility), but they must be registered and traceable in the system.

Importers must verify that the devices they are importing are registered in EUDAMED before placing them on the market. If a manufacturer's EUDAMED registration is incomplete, that creates a problem for the importer's compliance status as well.

Distributors

Distributors have the lightest EUDAMED obligations. Under MDR, distributors are not required to register as actors in EUDAMED in the same way as other economic operators. Their primary traceability obligations are met through the UDI system and their own record-keeping, not through direct EUDAMED registration.

However, distributors must be able to identify who the manufacturer, AR, and importer are for any device they handle — and those parties must be registered in EUDAMED. Distributors who deal in repackaged or relabelled devices take on additional obligations that may move them closer to the manufacturer role in EUDAMED terms.

What "mandatory" means in practice right now

The EUDAMED rollout has been graduated. As of the current MDR transition state:

• Actor registration (SRN) is mandatory for manufacturers with CE-marked MDR devices, ARs, and importers
• UDI/device registration obligations are active and are tied to CE marking — devices cannot be placed on the market without their UDI-DI registered in EUDAMED
• The vigilance module is operational and required for incident reporting
• PSUR submission via EUDAMED is required for Class IIb and III manufacturers

If you are operating under MDD transitional provisions (devices with MDD certificates extended under Regulation (EU) 2024/1860 or prior extensions), check the specific EUDAMED obligations that apply to your situation — the requirements for transitional devices are not identical to fully MDR-certified devices.

Common gaps

Not registering at actor level before attempting device registration. You need your SRN before you can register devices. Teams that jump to device registration without completing actor registration get stuck.

AR not set up in EUDAMED before launching into the market. Non-EU manufacturers sometimes begin placing devices on the market before their AR's EUDAMED registration is complete. This creates a traceability gap from day one.

Importers not verifying manufacturer EUDAMED status. An importer's due diligence must include confirming that the manufacturer or AR is registered in EUDAMED and that the relevant devices are registered with correct UDIs.

Forgetting to update EUDAMED when device information changes. EUDAMED is not a one-time registration — it must be kept current. Changes to the device (new UDI-DI, significant design changes), changes in the supply chain (new importer, new AR), and changes in certificate status all require EUDAMED updates.

Where to go from here

The vigilance reporting resource in this category covers the substance of what gets reported through EUDAMED's vigilance module. The PSUR vs PMSR resource explains which devices must submit PSURs through EUDAMED and at what intervals.