How does your company meet its EUDAMED obligations, from the SRN through to vigilance reporting?
We guide manufacturers, authorised 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, vigilance reports and PSUR submissions must run through the database. In practice, EUDAMED is less an IT project than a data quality project: the bottleneck is almost always consistency between the Basic UDI-DI, labelling and certificate scope, not the upload itself.
- MedTech
- IVD
Overview
What obligations does EUDAMED impose on manufacturers, authorised representatives and importers?
All six EUDAMED modules · MDR (EU 2017/745) Art. 33, IVDR (EU 2017/746) Art. 30 · MedTech & IVD
Last updated: 2026-06-12
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 has progressively made their use mandatory; since 28 May 2026 this also applies to vigilance and post-market surveillance. 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 authorised 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 labelling and certificate scope; UDI assignment runs through designated issuing entities such as GS1, HIBCC or ICCBBA (Implementing Decision (EU) 2019/939).
- Vigilance via EUDAMED: serious incidents (SAR) and field safety corrective actions (FSCA) have been reported through the database since 28 May 2026; 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 are submitted through the database; 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/actual comparison of actor, UDI, certificate, vigilance and PMS status. The result is a prioritised 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 authorised representative arrangement under Art. 11 MDR.
UDI data management
Mapping of Basic UDI-DI to UDI-DI, reconciliation with the current labelling and certificate scope, structured data migration into UDI and device registration under Art. 27 and 29 MDR.
Migrating the vigilance workflow to EUDAMED
Revision of the SAR and FSCA SOPs to the EUDAMED reporting channel under Art. 87 MDR, training of the vigilance team and documented test reports before the live case.
Learn more →Structuring PSUR & PMSR for EUDAMED compatibility
Review of existing reports against the upload requirements, plus EUDAMED-compliant PSUR and PMSR templates under Art. 85 and 86 MDR for upcoming reporting cycles.
Learn more →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, labelling 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 ability to report also hangs on this chain: vigilance reports and PSUR must run through the database, and the deadlines under Art. 87 MDR of 2 to 15 days leave no room to close registration gaps only once 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 labelling, 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 prioritised action list and a realistic sequence.
Actor registration
Valid SRN for the manufacturer and, where required, for the authorised representative.
UDI & device data
Complete entries in UDI and device registration, consistent with labelling 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 reports 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 authorised 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.
Since 28 May 2026, SAR and FSCA reports run through EUDAMED; anyone who has not migrated and tested the reporting channel 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.
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)
- 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
- https://theentourage.de/expertise/eudamed/ (existing page content, revised)
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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 (authorised representative)
- MDR Art. 27 (UDI system)
- MDR Art. 29 (registration of devices)
- MDR Art. 31 (registration of manufacturers, authorised 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)
- Implementing Decision (EU) 2019/939 (designated UDI issuing entities)
- MDCG 2023-3 (vigilance terms and concepts)
Related topics
MDR Consulting →
MDR compliance under EU 2017/745, from which the EUDAMED obligations follow
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
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