What does EUDAMED consulting deliver when your company has to meet its obligations from the SRN through UDI to vigilance reporting?
We guide manufacturers, authorized representatives and importers through all six EUDAMED modules, from actor registration (SRN) through UDI and device data to vigilance and post-market surveillance under Art. 33 MDR (EU 2017/745) and Art. 30 IVDR (EU 2017/746). Since 28 May 2026, the first four modules have been mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. The vigilance and clinical investigations or performance studies modules are not yet mandatory; vigilance reports continue to run through the established national channels for the time being. In practice, EUDAMED is less an IT project than a data quality project: the bottleneck is almost always consistency between the Basic UDI-DI, labeling and certificate scope, not the upload itself.
Overview
What obligations does EUDAMED impose on manufacturers, authorized representatives and importers?
All six EUDAMED modules · MDR (EU 2017/745) Art. 33, IVDR (EU 2017/746) Art. 30 · MedTech & IVD
Last updated: August 2, 2026
EUDAMED consolidates the registration and reporting obligations of Regulation (EU) 2017/745 (MDR, Art. 33) and Regulation (EU) 2017/746 (IVDR, Art. 30) into six modules. Regulation (EU) 2024/1860 makes their use mandatory module by module: a module becomes mandatory once the Commission formally confirms its functionality, followed by a six-month transition period. For the first four modules this happened with Commission Decision (EU) 2025/2371 (Official Journal, 27 November 2025); they have been mandatory since 28 May 2026. Vigilance and clinical investigations or performance studies will follow later. The points where projects most often get stuck:
- Actor registration as a prerequisite: without a valid Single Registration Number (SRN) under Art. 31 MDR, no further EUDAMED activity is possible. Manufacturers based outside the EU also need an authorized representative with their own SRN (Art. 11 MDR).
- UDI and device registration: the Basic UDI-DI and UDI-DI under Art. 27 and 29 MDR must be consistent with labeling and certificate scope; UDI assignment runs through designated issuing entities such as GS1, HIBCC or ICCBBA (Implementing Decision (EU) 2019/939).
- Vigilance not yet via EUDAMED: the vigilance module is not mandatory so far, voluntary use is possible. Serious incidents (SAR) and field safety corrective actions (FSCA) continue to be reported through the established national channels; the deadlines under Art. 87 MDR of 2 to 15 days remain unchanged (terminology clarified in MDCG 2023-3).
- PMS reports via EUDAMED: the PMSR for Class I under Art. 85 MDR and the PSUR for Classes IIa to III under Art. 86 MDR will be submitted through the database once the relevant module becomes mandatory; reports that are sound in content are often still not structured in a way that can be uploaded.
- Parallel obligations for IVDs: Art. 30 IVDR contains the corresponding registration obligations for in vitro diagnostics; the actor, UDI and vigilance logic applies analogously.
Services
How we support you
EUDAMED gap analysis
Module-by-module target-versus-actual comparison of actor, UDI, certificate, vigilance and PMS status. The result is a prioritized action list with clear responsibilities for each module.
Actor registration & SRN
Preparation and support for the SRN application under Art. 31 MDR, including reconciliation of the EORI number and commercial register data; for non-EU manufacturers, setting up the authorized representative arrangement under Art. 11 MDR.
UDI data management
Mapping of Basic UDI-DI to UDI-DI, reconciliation with the current labeling and certificate scope, structured data migration into UDI and device registration under Art. 27 and 29 MDR.
eQMS-EUDAMED interface
Requirements analysis between eQMS data fields and EUDAMED, interface design and go-live support, so that device, vigilance and PMS data do not have to be maintained twice.
How we work together
What it comes down to
EUDAMED enforces a sequence that cannot be short-circuited. Without a Single Registration Number (SRN) under Art. 31 of Regulation (EU) 2017/745 (MDR), not a single further module can be used, neither UDI registration nor a vigilance report. At the second stage, data quality is decisive: the Basic UDI-DI, UDI-DI, labeling and the scope of the notified body's certificate must all reflect the same product reality, otherwise every entry creates a finding risk for the next inspection. Since 28 May 2026, the first four modules have been mandatory: actors, UDI and devices, notified bodies and certificates, and market surveillance. The vigilance and clinical investigations modules are not yet mandatory; SAR and FSCA reports continue to run through the national channels until their functionality is formally confirmed. The deadlines under Art. 87 MDR of 2 to 15 days remain unchanged and, once the module becomes mandatory, will leave no room to close registration gaps only after an event occurs.
That is why we do not start with the upload, but with the gap analysis per module: which actors need an SRN, which device data deviates from the labeling, which certificate links are missing, which SOPs do not yet know the EUDAMED reporting channel. Only then do data migration and test reports follow, and operation is anchored in the QMS with designated accountability. EUDAMED is not a one-off IT project but an ongoing regulatory workflow; those who accept this early win back the time otherwise lost to data cleanup.
Our approach
Our approach
Step
Result
Gap analysis
Module-by-module EUDAMED status with a prioritized action list and a realistic sequence.
Actor registration
Valid SRN for the manufacturer and, where required, for the authorized representative.
UDI & device data
Complete entries in UDI and device registration, consistent with labeling and certificate scope.
Certificate reconciliation
Link between certificate and device entry verified with the notified body, scope discrepancies resolved.
Vigilance & PMS
SOPs migrated to the EUDAMED reporting channel, test submissions documented, PSUR and PMSR templates ready for submission.
Operation & accountability
Designated EUDAMED accountability within the company, ongoing data maintenance anchored in the QMS.
Common pitfalls
Where projects commonly fail
The SRN is underestimated as a formality.
Missing EORI numbers or inconsistent commercial register data block actor registration, and without an SRN no further module can be used. For non-EU manufacturers, there is the added requirement that the authorized representative needs its own SRN (Art. 11 MDR).
Basic UDI-DI and UDI-DI are confused or assigned incorrectly.
Product changes such as new pack sizes or software versions are not kept up to date; the EUDAMED entry then no longer reflects the actual market version and is treated as a documentation deficiency during inspections.
The vigilance process is still built around bilateral communication with authorities.
That is currently correct, because the vigilance module is not yet mandatory. Once the Commission confirms its functionality, exactly six months remain for the changeover; anyone who has not tested the EUDAMED reporting channel by then cannot formally meet the deadlines under Art. 87 MDR.
PSUR and PMSR are adequate in content but not ready for upload.
The structure and format do not match the EUDAMED requirements; the rework consumes exactly the time during the reporting cycle that is needed for the technical assessment.
EUDAMED is treated as a one-off IT project.
Without designated accountability for registrations, updates and reports, gaps arise in ongoing data maintenance that become visible at the latest during an audit or the next request from authorities.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR), primary text: Art. 11, 27, 29, 31, 33, 85, 86, 87
- Regulation (EU) 2017/746 (IVDR), primary text: Art. 30
- Regulation (EU) 2024/1860 (phased mandatory rollout of the EUDAMED modules)
- Commission Decision (EU) 2025/2371, Official Journal of 27 November 2025: confirmation of the functionality of the first four EUDAMED modules, mandatory from 28 May 2026, legacy devices by 28.11.2026, certificates by 28.05.2027
- Implementing Decision (EU) 2019/939 (designated UDI issuing entities)
- MDCG 2023-3 (vigilance terms and concepts)
- Writer source material: entourage-website-writer/output/landing-pages/eudamed/index.html
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR) Art. 33 (EUDAMED)
- MDR Art. 11 (authorized representative)
- MDR Art. 27 (UDI system)
- MDR Art. 29 (registration of devices)
- MDR Art. 31 (registration of manufacturers, authorized representatives and importers / SRN)
- MDR Art. 85 (PMSR)
- MDR Art. 86 (PSUR)
- MDR Art. 87 (vigilance reporting obligations)
- EU 2017/746 (IVDR) Art. 30 (EUDAMED)
- Regulation (EU) 2024/1860 (phased mandatory rollout of the EUDAMED modules)
- Commission Decision (EU) 2025/2371 (Official Journal, 27 November 2025): functionality of the first four EUDAMED modules, mandatory since 28 May 2026
- Implementing Decision (EU) 2019/939 (designated UDI issuing entities)
- MDCG 2023-3 (vigilance terms and concepts)
Related topics
MDR Conformity →
MDR compliance under EU 2017/745, from which the EUDAMED obligations follow
IVD Consulting & IVDR Readiness →
The counterpart for in vitro diagnostics under EU 2017/746
Medical Device Vigilance →
SAR and FSCA reports under Art. 87 MDR in detail
Post-Market Surveillance →
PSUR and PMSR obligations under Art. 85 and 86 MDR
Have a concrete project?
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