EUDAMED Readiness: Why Registrations Fail in Practice

In many companies, EUDAMED is still treated as an IT project: a portal you load data into once the deadline draws near. That framing is the heart of the problem. The European Database on Medical Devices (EUDAMED) is not an upload tool but the prescribed reporting channel for regulatory obligations that exist regardless. Since 28 May 2026, vigilance reporting, the Periodic Safety Update Report (PSUR) and the Post-Market Surveillance Report (PMSR) must be submitted through the database. Anyone without complete registration by then does not fail on the technology; they fail on the deadline.

EUDAMED Is Mandatory, Not Optional

The legal basis is set out in Art. 33 of Regulation (EU) 2017/745 (MDR) for medical devices and in Art. 30 of Regulation (EU) 2017/746 (IVDR) for in vitro diagnostics. EUDAMED comprises six modules: actor registration, UDI and device registration, notified bodies and certificates, clinical investigations, performance studies, and vigilance and post-market surveillance.

The phased mandatory use of these modules was triggered by Regulation (EU) 2024/1860. The sequence is decisive: actor registration is the prerequisite for every further activity in EUDAMED. Without it, a company simply does not exist in the database, and no UDI, no vigilance report and no report can be submitted.

The obligations apply to manufacturers, authorised representatives and importers in the MedTech and IVD domains. For IVD, the risk class is additionally relevant: the IVDR staggers the transition periods by class, so full applicability takes effect at different points in time depending on the device. This is precisely where the first misjudgements arise, because companies with a mixed portfolio assume that a single deadline applies to everything.

Four Clusters Where Registrations Get Stuck

In implementation projects, we encounter the same four patterns, almost regardless of company size.

• Incomplete actor registration. Without a valid Single Registration Number (SRN) under Art. 31 MDR, nothing moves forward. The EORI number or consistent commercial register data are often missing, which blocks the application. Manufacturers based outside the EU additionally require an authorised representative with their own SRN under Art. 11 MDR. If this constellation is not cleanly set up, the entire project stalls before it has begun.

• Inconsistent UDI data. Basic UDI-DI and UDI-DI are confused or assigned incorrectly. Device changes, new pack sizes or software versions are not updated promptly, so the EUDAMED entry no longer reflects the actual version on the market. UDI assignment runs through designated issuing entities such as GS1, HIBCC or ICCBBA (Implementing Decision (EU) 2019/939). During an inspection, any discrepancy between labelling, certificate scope and database entry is treated as a documentation deficiency, not a trivial matter.

• Vigilance workflow not migrated. Many manufacturers still report serious incidents and field safety corrective actions (FSCA) to the national authorities by email. Since 28 May 2026, electronic reporting under Art. 87 MDR is carried out through EUDAMED. The short reporting deadlines remain unchanged. Anyone who has not switched over the workflow cannot formally meet them through the prescribed channel, even if the vigilance team is fully capable on the substance. The relevant definitions are set out in MDCG 2023-3.

• PMS documentation not upload-ready. The PMSR for Class I under Art. 85 MDR and the PSUR for the higher classes under Art. 86 MDR are submitted through EUDAMED. Reports that are strong on content are nonetheless often incompatible, because their structure and format do not meet the database's requirements. The rework takes more time than expected, especially where there is no interface to the eQMS and everything has to be transferred manually.

Why Mistaking It for an IT Project Becomes Costly

Treating EUDAMED as a pure data problem leads to mis-scheduling it. The central sticking point is rarely the upload itself but data quality: the consistency between the Basic UDI-DI, device labelling and the scope of the certificates. Establishing this consistency is regulatory work and requires lead time, because it calls for coordination with the notified body, with quality management and, in part, with suppliers.

There is also the ongoing nature of the obligation. EUDAMED is not a one-off project with a completion date. Device changes, vigilance reports and reporting cycles must be maintained continuously. Where a clearly assigned responsibility is missing, gaps form in exactly those places, surfacing at the next inspection. With larger portfolios, the problem intensifies, because manual duplicate maintenance without an eQMS interface is not only time-consuming but error-prone.

What to Do Now

A sensible approach is a module-by-module gap analysis prioritised by the time remaining. In concrete terms, this means:

• SRN first. Secure actor registration under Art. 31 MDR and, for non-EU manufacturers, verify the authorised representative constellation under Art. 11 MDR. Everything else builds on this.
• Clean up UDI data. Map Basic UDI-DI to UDI-DI, reconcile against labelling and certificate scope under Art. 27 and Art. 29 MDR, then carry out a structured migration.
• Switch vigilance and PMS to the reporting channel. Revise SOPs for incident and FSCA reporting to reflect EUDAMED reporting under Art. 87 MDR, check the PSUR and PMSR under Art. 85 and Art. 86 MDR for upload compatibility, and test before the real case arises.

Entourage supports manufacturers, authorised representatives and importers in MedTech and IVD across all six modules, from the SRN to the vigilance workflow. The starting point is usually a gap analysis that records the status per module and derives a realistic sequence toward being able to meet the reporting obligations. Where the parallel obligations of the IVDR apply, the same actor, UDI and vigilance logic holds, with Art. 30 IVDR as the EUDAMED legal basis for in vitro diagnostics.