EUDAMED has evolved from an essentially voluntary system to a fully operational compliance requirement throughout Europe. European Union for medical devices and In Vitro diagnostic (IVD) businesses which operate within Germany, 28 May 2026 was a crucial regulatory event. At that time four EUDAMED modules were made obligatory: Actor Registration, Notified Bodies, UDI/Device Registration and Certificates, as well as Market surveillance. The first three are the requirement for direct registration or reporting for the relevant economic players along with Notified Bodies, while the Market Surveillance module is used primarily by the national authorities responsible for compliance and The European Commission.
For those who manage EUDAMED registration in Germany compliance is not just about the creation of an account. The procedure connects the registration of economic operators with using the single Registration Number (SRN) as well as information about devices and UDI Compliance, Notified Body certificate information as well as Germany’s departure from the national DMIDS registration of products. Performance and clinical research sponsors should be evaluated in a separate manner. As of August 2026, the Clinical Investigations/Performance Studies (CI/PS) module is not yet mandatory. If the module is made obligatory, sponsors will have to sign up as actors and get an Actor ID in order to access this module. The registration of sponsors is therefore not a part of the 28 May 2026 launch.
What Became Mandatory in EUDAMED on 28 May 2026?
The European Commission formally declared the four initial EUDAMED modules operational by Commission Decision (EU) 2025/2371 that was released on November 20, 2025. Regulation (EU) 2024/1860 set the framework for transition that made them mandatory beginning on the 28th of May 2026.
The EUDAMED mandatory Registration modules are:
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Post Market Surveillance
The Market Surveillance module should not be confused with a manufacturer registration requirement. It is mandatory for competent authorities and the European Commission, rather than a module that manufacturers populate in the same way as Actor or UDI/Device registration.
Two other EUDAMED modules are not yet mandatory:
- Post-Market Surveillance and Vigilance
- Clinical Investigations and Performance Studies
This is why EUDAMED mandatory registration should not be treated as one deadline that applies in the same way to every organisation or every regulatory activity.
Who Needs EUDAMED Registration in Germany?
The Actor Registration module covers defined economic operators and other actors that need to perform specific activities in EUDAMED.
Manufacturers, authorised representatives, importers and system/procedure pack producers that are subject to the relevant requirements must register in EUDAMED before carrying out activities that depend on Actor registration.
Requirements for Non-EU Manufacturers
Manufacturers established outside the EU need an EU authorised representative before completing the relevant EUDAMED Actor registration.
A non-EU manufacturer must also submit a mandate summary document with its Actor registration request. The authorised representative must already be appropriately registered so that the relationship can be established within EUDAMED.
This makes authorised representative selection an early regulatory step rather than something to address after device registration has started.
BfArM Medical Device Registration: What Happens to DMIDS?
Germany has historically relied on the Deutsches Medizinprodukte-Informations– und Datenbanksystem (DMIDS) for national medical-device information and regulatory processes.
The 2026 EUDAMED transition changes that system for product registration.
BfArM states that products had to continue being registered in DMIDS until EUDAMED became mandatory on 28 May 2026. A six-month transition then applies to relevant products already on the market, with the important 28 November 2026 deadline for applicable MDR, IVDR and legacy devices that continue to be placed on the market.
One important point for companies searching for BfArM medical devices registration is that DMIDS and EUDAMED should not be treated as interchangeable databases.
BfArM confirms that automatic transfer of data from DMIDS to EUDAMED is not possible. Existing DMIDS records therefore should not be assumed to satisfy an EUDAMED registration requirement.
Who Validates the EUDAMED SRN in Germany?
The Single Registration Number (SRN) is the EU-wide identifier generated by EUDAMED for registered economic operators in the medical-device sector. An Actor Registration request is submitted through EUDAMED. Once the relevant national competent authority assesses and approves the request, EUDAMED generates the Actor ID/SRN.
In Germany, BfArM explains that the organisation’s competent surveillance authority validates the registration information. BfArM itself is therefore not automatically the authority validating every production EUDAMED registration. Identifying the correct German authority should be one of the first steps in the registration process.
Step-by-Step EUDAMED Registration Process for Germany
1. Identify the Correct Economic-Operator Role
Before entering information, determine whether the organisation acts as:
- Manufacturer
- Non-EU manufacturer
- Authorised representative
- Importer
- System/procedure pack producer
- Clinical investigation or performance study sponsor
The role should reflect the organisation’s legal responsibilities under the MDR or IVDR, not simply its commercial relationship with the device.
2. Complete Actor Registration
Eligible economic operators submit an Actor registration request through EUDAMED.
All actors must provide the required signed declaration on information security responsibilities. Non-EU manufacturers also need an active EU authorised representative and the appropriate mandate summary documentation.
Once the competent authority approves the request, EUDAMED generates the Actor ID/SRN.
The SRN then becomes an important identifier linking the organisation with other regulatory records within EUDAMED.
3. Prepare Device Master Data Before Submission
Manufacturers should establish a controlled and verified device dataset before starting large-scale registration.
Typical information includes:
- Basic UDI-DI
- UDI-DI
- Device name and model
- Manufacturer details
- Risk classification
- Applicable MDR or IVDR framework
- EMDN nomenclature
- Intended purpose
- Certificate information where applicable
- Authorised representative information
- Device status
Manufacturers are responsible for submitting the required UDI/device information for devices they place on the EU market.
Device information should be checked against labels, declarations of conformity, technical documentation and certificates before submission. Small inconsistencies in manufacturer names, identifiers or device details can create unnecessary problems across connected EUDAMED records.
Understand the 28 November 2026 EUDAMED Device Registration Deadline
The 28 May 2026 date does not mean that every device previously placed on the EU market had to be retrospectively registered on that day.
For applicable legacy and MDR/IVDR devices whose first units were placed on the market before mandatory use, but where additional units continue to be placed on the market after 28 May 2026, the transition period runs until 28 November 2026.
By contrast, where the first unit of a new MDR- or IVDR-regulated device is placed on the EU market on or after 28 May 2026, the required device registration generally needs to be completed before that first unit is placed on the market.
For organisations managing large portfolios, it helps to separate products into:
- Devices already registered correctly in EUDAMED
- Existing devices requiring registration by 28 November 2026
- New products requiring registration before market placement
- Products no longer being placed on the market
- Legacy devices subject to applicable transitional provisions
This avoids spending regulatory resources on low-priority records while active products approach a EUDAMED mandatory Registration deadline.
Which MDR/IVDR Notified Body Certificates Are Registered in EUDAMED?
The Notified Bodies and Certificates module also became mandatory on 28 May 2026.
The certificates covered here are not general business certificates or standards such as ISO 13485. They are conformity-assessment certificates issued by Notified Bodies under the MDR and IVDR.
For MDR devices, these include:
- EU Quality Management System certificates
- EU Technical Documentation certificates
- EU Type Examination certificates
- EU Quality Assurance certificates
- EU Product Verification certificates
For IVDs under the IVDR, they include:
- EU Quality Management System certificates
- EU Technical Documentation certificates
- EU Type Examination certificates
- EU Production Quality Assurance certificates
Primary source: European Commission — EUDAMED Notified Bodies & Certificates module.
The responsibility for registering this certificate information primarily rests with the Notified Body, not the manufacturer. Notified Bodies must enter information relating to certificates that are issued, amended, supplemented, suspended, reinstated, withdrawn, refused or otherwise restricted.
Manufacturers still need to make sure that related information—particularly manufacturer details, authorised representative information where applicable, and Basic UDI-DIs—is accurate because the Notified Body may need to reference these records.
For relevant MDR/IVDR certificates issued before mandatory use of the module, a transition period applies, with the Commission’s current timeline showing 28 May 2027 as the deadline for registering the required certificate information.
Special Considerations for IVD Manufacturers in Germany
IVDs use the same overall EUDAMED infrastructure but remain regulated under the IVDR rather than the MDR.
IVD manufacturers should align:
- IVDR classification
- Basic UDI-DI and UDI-DI data
- Actor/SRN information
- Authorised representative information where applicable
- Notified Body certification where required
- Performance evaluation documentation
- Applicable transitional status
EUDAMED device registration should also not be confused with UDI labelling and UDI-carrier implementation requirements. These requirements are connected through the IVDR traceability framework, but they are not identical obligations.
What Does the EUDAMED registration 2026 Change Mean for Clinical Study Sponsors?
Clinical investigation and performance study sponsors need a separate compliance approach.
The European Commission’s latest gradual-rollout guidance explains that sponsors will need to register as actors in the Actor module and obtain an Actor ID so they can use the Clinical Investigations/Performance Studies module for activities such as submitting study applications or reporting serious adverse events. However, the same guidance makes clear that sponsor registration will only become possible when the CI/PS module becomes mandatory. As of August 2026, that module remains under development/analysis and is not part of the current mandatory rollout.
Until then, Germany-specific processes for clinical investigations and performance studies remain relevant, including applicable DMIDS procedures. A company can also be both a sponsor and a manufacturer. In that situation, its manufacturer role may independently trigger current Actor and device-registration obligations even though sponsor-specific EUDAMED functionality is not yet mandatory.
Common EUDAMED Compliance Errors in Germany
Assuming DMIDS Data Automatically Transfers to EUDAMED
It does not. BfArM confirms that automatic transfer or synchronisation between DMIDS and EUDAMED is not available.
Waiting Too Long for SRN Validation
Device registration and other EUDAMED activities can depend on Actor registration. Authority validation time should therefore be included in launch planning.
Treating Sponsor Registration as Already Mandatory
Sponsors will need Actor registration when the CI/PS module becomes mandatory, but sponsor-specific registration is not currently part of the 28 May 2026 mandatory rollout.
Using Inconsistent Legal Entity Information
Manufacturer names and addresses should remain consistent across EUDAMED records, certificates, technical documentation and declarations of conformity.
Missing the 28 November 2026 Transition Deadline
Companies that placed relevant devices on the market before 28 May 2026 and continue placing additional units on the market should identify affected records well before the deadline.
How Regulatory Services in Germany Can Support EUDAMED Compliance
For non-EU manufacturers or organisations managing large device portfolios, Regulatory Services in Germany can help coordinate EUDAMED requirements with Germany’s remaining national regulatory processes.
Support may include:
- MDR/IVDR regulatory pathway assessment
- Economic-operator role determination
- Authorised representative coordination
- Actor and SRN registration support
- UDI and Basic UDI-DI data preparation
- EUDAMED device-data review
- DMIDS-to-EUDAMED transition assessment
- Notified Body certificate-data reconciliation
- Regulatory database gap analysis
- Clinical investigation and performance-study pathway support
- Ongoing registration-data maintenance
The objective should not simply be to enter records into EUDAMED. A stronger approach is to maintain one controlled regulatory dataset that stays consistent across EUDAMED, certificates, technical documentation, product labels and internal quality systems.
EUDAMED vs DMIDS: What Is the Difference?
Conclusion
EUDAMED is now a central part of medical device and IVD compliance in Germany, with mandatory use of key modules applying since 28 May 2026. Manufacturers, authorised representatives, importers and other relevant economic operators need to ensure that Actor registration, SRN information and device data are accurate and aligned with MDR or IVDR requirements. A structured compliance approach, supported where needed by experienced Regulatory Services in Germany, can reduce registration errors, maintain consistency across regulatory records and make long-term EU market access easier to manage.
How Can DDReg Help for EUDAMED Registration?
DDReg provides Regulatory Services in Germany to support medical device and IVD companies through the EUDAMED registration and compliance process. From determining the correct economic-operator role and supporting Actor/SRN registration to preparing UDI and device data, assessing DMIDS-to-EUDAMED transition requirements, and reconciling Notified Body certificate information, DDReg works with companies across each stage of EUDAMED Registration Germany.
The support can also extend to MDR/IVDR compliance, authorised representative coordination, regulatory data review, portfolio gap assessments, and ongoing EUDAMED record maintenance. This helps manufacturers, importers and other relevant economic operators keep their regulatory information accurate, consistent and aligned with current EU and German requirements.
Frequently Asked questions (FAQs)
Applicable devices placed on the market before 28 May 2026 and continuing to be placed on the market generally have until 28 November 2026 to complete the required UDI/Device registration.
Yes. BfArM states that German importers are required to register in EUDAMED. There is no corresponding general importer-registration obligation in Germany's DMIDS.
The SRN is generated automatically by EUDAMED after the relevant competent German surveillance authority validates and registers the Actor information. BfArM is not automatically the validating authority for every production registration.
Sponsors will need to register as actors and obtain an Actor ID when the Clinical Investigations/Performance Studies module becomes mandatory. As of August 2026, sponsor registration is not yet available because the CI/PS module is not yet mandatory.
No. BfArM confirms that data cannot be automatically transferred from DMIDS to EUDAMED. Companies should separately verify that all required EUDAMED records have been created and are accurate.