The assumption is understandable: data has been entered, the system has accepted it, something is sitting in EUDAMED. Surely that counts for something.
It does not. An EUDAMED draft is invisible to national competent authorities for compliance purposes. It cannot be referenced in an inspection, it does not satisfy registration obligations, and it offers no regulatory standing in the event of a query. After May 28, the distinction between draft and published data goes from administrative detail to legal exposure.
What “Draft” Actually Means in EUDAMED
EUDAMED operates on a publish/submit model. Data entered but not published – whether for actor registration, device records, UDI assignment, or certificate linkage – exists only in a staging state. The system holds it, but it has not been formally submitted or made available to the competent authorities who use the database as their primary compliance reference.
EUDAMED registration is not completed by the act of entering data. It is completed when that data is published and validated. Draft records do not trigger that process. They are, in practical terms, the regulatory equivalent of an unsigned document sitting in a drawer.
Draft Records, Real Consequences
The May 28 mandatory date is enforced at the Member-State level. National competent authorities cross-reference EUDAMED during inspections, post-market reviews, and incident assessments. If a record is in draft, it does not appear in those checks as a compliant registration.
The risks associated with having only EUDAMED draft registrations, rather than completed submissions, after the deadline are concrete:
- Market access challenges in member states where authorities conduct active checks
- Audit findings that are difficult to remediate quickly under deadline pressure
- Credibility issues before Notified Bodies and regulators that can persist beyond the immediate compliance gap
The European Commission’s medical devices regulation overview covers what full registration requires under both MDR and IVDR, and it is worth checking device records against it if there is any uncertainty about which modules need to be published, not just populated.
Is Draft Data Compliant in EUDAMED?
No. Draft status means the data has not been formally submitted, which means the registration obligation has not been met – full stop.
A record that is 90% complete and saved as a draft looks like progress internally. From a regulatory standpoint, it is indistinguishable from having done nothing at all.
It is also worth noting that some errors only surface at the point of publication – EMDN code mismatches, certificate scope inconsistencies, entity detail conflicts. Organisations working in draft without attempting to publish may not yet know how much remediation their records still require.
What Needs to Happen Before May 28
Draft records across all modules need to be reviewed, corrected where necessary, and published:
- Actor registration – legal entity details verified, SRN active, EAR link confirmed and published
- Device and UDI data – EMDN codes checked against CE certificate scope, Basic UDI-DI registered and submitted
- Certificate linkage – notified body certificates registered, linked to device records, scope consistent throughout
- Post-market obligations – serious incident and FSCA reporting pathways confirmed and documented, not just acknowledged
Each module has its own validation logic, and errors in one can hold up publication across others. Treating draft clearance as a quick final step underestimates what is often involved.
How Obelis Supports Your Business
As part of its role as authorised representative, Obelis works directly with manufacturersto move EUDAMED records from draft to published – and to ensure everything is correct before submission is attempted.
That includes EUDAMED Registration support across all relevant modules, Authorised Representative (EAR) services for non-EU manufacturers, Technical File Review, and QMS Support covering ongoing data maintenance obligations.
Where legal review is needed – EAR contracts, GDPR considerations, or liability questions arising from registration gaps – Legal Services are part of the offer too.
Scheduling a call with Obelis is the fastest way to get clarity on what still needs to happen before May 28.
FAQs
No. Draft records are not visible to national competent authorities the way published records are. An inspector reviewing EUDAMED will not see unpublished data as a compliant registration, regardless of how complete it looks internally.
Devices without published UDI and certificate records lack verified regulatory standing. This creates serious exposure during any competent authority check, audit, or incident review – and the risk compounds across Member States if you operate in multiple EU markets.
Validation failures at submission are common, particularly around EMDN codes and certificate scope alignment. They need to be resolved before the record can be published – which is exactly why leaving draft clearance until the final days is risky. There may be far less time to fix errors than expected once they surface.
Leave a Reply