EUDAMED Registration – A Comprehensive Guide for Manufacturers

EUDAMED registration is an important part of placing and managing medical devices on the European Union market under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).

The European Database on Medical Devices (EUDAMED) brings together information about economic operators, medical devices, certificates and market surveillance in a single European system.

Since 28 May 2026, the first four EUDAMED modules have become mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance.

For manufacturers, however, EUDAMED registration is more than simply creating an account and obtaining a Single Registration Number (SRN). It involves making sure that company, regulatory and device information is accurate, consistent and maintained over time.

This guide explains what EUDAMED registration involves, who needs to register, what manufacturers should prepare and where the main challenges typically arise.

What is EUDAMED Registration?

EUDAMED is the European Database on Medical Devices established under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

The database is designed to improve transparency and traceability of medical devices on the EU market and to facilitate the exchange of information between manufacturers, other economic operators, Notified Bodies, competent authorities and the European Commission.

When referring to “EUDAMED registration”, it is important to understand that this can involve several different activities.

Actor Registration identifies the economic operator in EUDAMED and, once approved, results in a Single Registration Number (SRN).

UDI/Device Registration concerns the information that manufacturers must submit about the medical devices they place on the EU market.

Other EUDAMED modules cover areas such as Notified Bodies and Certificates and Market Surveillance.

Therefore, obtaining an SRN is an important step, but it does not represent the entirety of a manufacturer’s EUDAMED obligations.

Who Needs to Register in EUDAMED?

The Actor Registration module covers economic operators such as:

• Manufacturers
• Authorized Representatives
• Importers
• Producers of systems or procedure packs

For manufacturers located outside the EU, an Authorized Representative is required where the MDR or IVDR requires one.

The precise obligations can depend on the type of economic operator, the devices involved and the applicable regulatory and transitional provisions.

For this reason, determining what needs to be registered should come before starting the registration process itself.

How Does EUDAMED Registration Work?

EUDAMED registration is best understood as a process involving several connected steps rather than a single registration form.

Actor Registration and the SRN

The first stage for an economic operator is generally Actor Registration.

The manufacturer provides the legal and regulatory information required for its organization and actor role. Once the registration request has been assessed and approved, the manufacturer receives a Single Registration Number (SRN).

The SRN identifies the economic operator within EUDAMED. It should not be confused with the identification of individual medical devices.

Authorized Representative

For manufacturers established outside the EU, the relationship with an EU Authorized Representative is an important part of the regulatory framework.

The manufacturer and Authorized Representative must ensure that their information and mandate are correctly reflected in EUDAMED where applicable.

Errors or inconsistencies between the manufacturer’s regulatory documentation and the information recorded in EUDAMED can create unnecessary complications.

Device and UDI Registration

Actor Registration is only one part of the process.

Manufacturers must also address the registration of the medical devices they place on the EU market through the UDI/Device Registration module, subject to the applicable MDR or IVDR requirements and transitional provisions.

UDI plays an important role in device identification, while EUDAMED provides the database in which the required device information is registered.

The two concepts are therefore closely connected, but they are not the same thing.

A manufacturer needs to ensure that the information relating to its devices, identification and regulatory status is accurate and consistent before submitting it to EUDAMED.

Certificates and Other Regulatory Information

EUDAMED also includes a dedicated Notified Bodies & Certificates module.

Where a manufacturer’s devices are subject to conformity assessment involving a Notified Body, relevant certificate information forms part of the wider EUDAMED framework.

This means that manufacturers need to consider not only their own actor and device information, but also how applicable regulatory information and certificates fit together within the database.

What Do You Need Before Starting EUDAMED Registration?

One of the most important parts of the process happens before submitting any information to EUDAMED.

Manufacturers should first make sure that the information they intend to provide is complete, accurate and consistent with their existing regulatory documentation.

This may include:

• Legal entity and company information
• Regulatory contact information
• PRRC information, where applicable
• Authorized Representative information, where applicable
• Relevant device and UDI information
• Applicable regulatory and certification information
• Supporting documentation required for the actor registration

For example, the European Commission requires documentation as part of the Actor Registration process, with specific requirements depending on the type of actor and circumstances.

For non-EU manufacturers, an active Authorized Representative and the relevant mandate information are particularly important.

The exact documentation and information required can vary, so manufacturers should check the current EUDAMED requirements before beginning the process.

What Happens After EUDAMED Registration?

EUDAMED registration should not be treated as a one-time administrative exercise.

Once an organization and its devices are registered, manufacturers need to ensure that relevant information remains accurate and up to date.

Changes to company information, Authorized Representative relationships, devices, UDI information or applicable certificates may require corresponding updates.

This is one of the reasons why EUDAMED should be considered part of an ongoing regulatory compliance process rather than simply a registration task.

Manufacturers should also ensure that EUDAMED information remains consistent with their technical documentation and other regulatory records.

Common EUDAMED Registration Mistakes

Although the registration process may appear straightforward, problems often arise from inconsistencies between different sources of regulatory information.

Common issues include:

Inconsistent Company Information

The legal entity information submitted to EUDAMED should correspond with the manufacturer’s official documentation.

Even apparently minor inconsistencies can complicate the registration or verification process.

Problems With Authorized Representative Information

For non-EU manufacturers, the relationship with the Authorized Representative must be correctly established and reflected in the relevant regulatory records.

Incomplete Device Information

Device registration involves more than simply entering a product name.

Manufacturers need to ensure that the information submitted for their devices is accurate and aligned with their regulatory documentation and applicable UDI requirements.

UDI-Related Inconsistencies

UDI information needs to be consistent with the device information and identification data used elsewhere in the manufacturer’s regulatory processes.

Certificate Information

Where applicable, information concerning Notified Body certificates needs to be accurate and properly aligned with the relevant devices and regulatory records.

Failure to Keep Information Updated

EUDAMED information can become inaccurate when companies, devices, regulatory representatives or certificates change.

Manufacturers should therefore have an internal process for monitoring and updating their EUDAMED information when necessary.

EUDAMED Registration: Current Requirements and Key Dates

EUDAMED is being implemented through a gradual process under the MDR and IVDR.

As of 28 May 2026, the following four modules became mandatory to use:

• Actor Registration
• UDI/Device Registration
• Notified Bodies & Certificates
• Market Surveillance

Other modules, including Vigilance and Post-Market Surveillance and Clinical Investigations & Performance Studies, follow their own implementation timeline.

There are also transitional provisions relating to certain device and certificate registration obligations.

Because EUDAMED implementation continues to evolve, manufacturers should always verify the latest European Commission requirements when assessing their specific obligations and deadlines.

Frequently Asked Questions About EUDAMED Registration

Is EUDAMED registration mandatory?

Yes. The mandatory use of EUDAMED depends on the applicable module and regulatory requirement. Since 28 May 2026, the first four EUDAMED modules are mandatory to use within their respective scopes.

What is an SRN in EUDAMED?

An SRN, or Single Registration Number, is the unique identifier assigned to an economic operator following successful Actor Registration.

It identifies the organization and should not be confused with the identification of individual medical devices.

Is EUDAMED registration the same as device registration?

No. Actor Registration identifies the economic operator and results in an SRN. Device Registration concerns the information relating to the medical devices placed on the EU market.

Both form part of the wider EUDAMED framework.

Do non-EU manufacturers need an Authorized Representative?

Where required by the MDR or IVDR, yes.

Non-EU manufacturers need an EU Authorized Representative to access the EU market under the applicable regulatory framework, and the relevant relationship must be correctly reflected in EUDAMED.

Do I need to register my medical devices in EUDAMED?

Manufacturers must submit the required UDI and device information through the UDI/Device Registration module, subject to the applicable regulatory and transitional requirements.

What documents are needed for EUDAMED registration?

The documentation required depends on the type of actor and the specific circumstances.

Manufacturers should prepare their legal, regulatory and organizational information in advance and verify the current European Commission requirements before submitting an Actor Registration request.

Is EUDAMED registration a one-time process?

No. Although Actor Registration results in an SRN, manufacturers have ongoing responsibilities concerning the accuracy and maintenance of relevant information in EUDAMED.

Need Help With EUDAMED Registration?

EUDAMED registration may look like a straightforward administrative process, but ensuring that the information submitted is accurate, complete and consistent with your regulatory documentation can be challenging.

For manufacturers, the work often involves coordinating company information, Authorized Representative details, device and UDI data, certificates and other regulatory information across different records and requirements.

CMC Medical Devices can support manufacturers with EUDAMED registration and help ensure that the process is handled correctly and efficiently.

Need support with EUDAMED registration? Contact CMC Medical Devices to discuss your requirements.