Who Must Register

The following organizations must register in EUDAMED:

Each of these types of companies must register as an ‘Actor’ and obtain a ‘Single Registration Number’ (SRN).

If you market both CE Marked devices and procedure packs, you must obtain two SRNs.

The following products must be registered in EUDAMED:

Registration is required for each individual device, and not just a single notification covering the family of devices.

For MDR/IVDR devices, registration is per UDI-DI.

For MDD/AIMDD/IVDD legacy devices, a UDI system is not yet mandatory. If the manufacturer has already voluntarily implemented a UDI system, then they can register per UDI-DI.

If the legacy device does not yet have a UDI-DI assigned, then each device code/catalogue number/reference number/variant must be registered individually. Then, the system will auto-generate a ‘EUDAMED-ID’ for each individual device.

How is compliance checked?

Many entities are tasked with ensuring manufacturers have met this requirement. For example, your EU Authorized Representative and Importer both have a legal obligation to verify that you have registered your devices in EUDAMED. Your Notified Body, if applicable, will also verify compliance as part of their conformity assessment activities.

If you have not registered by the deadline, your EU Authorized Representative may flag the non-compliance and request immediate action, and shipments may be held by your importer until registration is complete. To avoid operational disruptions, manufacturers should prioritize registering in a timely manner.

EUDAMED Mandatory Use Dates

Devices on the market before 28 May 2026

If your device was already on the market before 28 May 2026, then you have a six-month transition period to enter all your devices into EUDAMED. All of your devices must be registered in EUDAMED by 28 November 2026, or you risk non-compliance.

Devices new to market on or after 28 May 2026

Any device newly introduced to the market on, or after, 28 May 2026, must be registered in EUDAMED before being placed on the market. There is no exception to this requirement.

How to Register Devices

Companies have three options to register their devices in EUDAMED.

Manual Entry

This requires the manufacturer to enter each device one-by-one into EUDAMED.

Each device will take approximately 5-10 minutes to enter. Therefore, up until a certain number of devices, this remains the most straightforward way to comply. If you have more than 150 devices and have limited time to dedicate to this, then you may want to consider pricing out the below options.

XML File

This process is generally not feasible for the layperson. Companies likely need to outsource this through a third-party company that offers EUDAMED support.

In this process, the manufacturer typically completes an excel sheet with all the required information, row-by-row. Then this excel sheet is converted into XML format, and uploaded to EUDAMED.

However, there are limitations to this. For example, if there’s a single mistake in the file, your upload may fail. Or if there are too many devices in the file, EUDAMED may time out, requiring the files to be separated out.

Machine-to-Machine (M2M)

This option is the most complicated. Essentially, M2M (Machine-to-Machine) means the company’s own internal system communicates directly with EUDAMED’s system automatically. The company maintains their own database (e.g., product/UDI database) structured to match EUDAMED’s data requirements, and that system is connected to EUDAMED via the Access Point. Data can then flow from the internal database, automatically into EUDAMED.

Companies must first request M2M access, and provide information about the volume of data to be exchanged and why M2M access is warranted. Further, it requires ensuring that their internal data model stays current with all EUDAMED versions/iterations.

Generally, if a company is small-to-mid-sized, then setting up their own M2M system is impractical. Instead, they can hire a company that offers professional EUDAMED M2M services. Essentially, these companies act as an intermediary EUDAMED Access Point on behalf of multiple clients.

National Registration Requirements

Pre-EUDAMED National Registration Requirements

Prior to the mandatory use of EUDAMED, the registration requirements under the old Directives (MDD/AIMDD/IVDD) applied:

Class I devices and IVDs: Per the MDD, all Class I devices must be registered by the manufacturer (or its authorized representative) in the member state where they are located. Per the IVDD, all IVDs must be registered by the manufacturer (or its authorized representative) in the member state where they are located.

Class IIa, IIb, III/AIMD Devices: Per the MDD/AIMDD, each Competent Authority (e.g., AEMPS in Spain) may decide on a case-by-case basis if they wish to be informed of Class IIa, IIb and III/AIMD devices being placed onto their market. Each country may also maintain its own medical device registration database.

Annex II List A, List B, and self-test IVDs: Per the IVDD, each member state may decide on a case-by-case basis if they wish to receive additional details related to Annex II, List A, List B and/or self-test products (e.g., label and IFU).

Post-EUDAMED National Registration Requirements

EUDAMED is intended to act as a centralized database of all medical devices marketed in Europe, and therefore, in theory, replace the above local Competent Authority (CA) registration requirements.

Most of the CAs that required registration of Class IIa, IIb, and III devices under the old system, have confirmed that they will transition to EUDAMED, i.e., it will replace their previous local registration requirement. For example, Belgium (see here and here) and Germany indicate that EUDAMED, once mandatory, will replace their local systems. In these cases, when registering devices, manufacturers must ensure the appropriate countries are selected for where the device will be marketed.

However, some have indicated that their local registration requirements will remain in place, in addition to EUDAMED. For example, Slovakia.

COMING SOON: Over the next month, Casus will update its EU Registration Requirements page to reflect the post-EUDAMED requirements by each Competent Authority. Once finalized, we will inform interested parties via our monthly Regulatory Newsletter.

Resources

Casus has the following resources available to help you get started:

Additionally, we have a downloadable Resource Guide which provides direct links to the EUDAMED database, official user guides, and more.