EUDAMED certificates: registration metadata versus linked notified-body records
The acquired Basic UDI dictionary distinguishes certificate information supplied with device registration from certificates linked in EUDAMED, whose update notes refer to notified-body action. These are separate record relationships; a populated field is not proof of a current valid certificate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Sourced criteria · EU · EUDAMED
What changes the service scope?
Decision or task
What the source describes
What to prepare
DD BASIC UDI / FLD-UDID-39 / Device Certificate Information associated with the Device
Description: References the Device Certificate Information completed together with the registration of the Device
When registering the Device , Device Certificate information is required when the Regulation Device is covered by a Product Certificate (required to provide the Notified Body and optional Certificate Number and Certificate Date) | Occurrence: 0..1 | Updateability: not stated | Referenced rules: BR-UDID-109
BR-UDID-110 | XML mapping: deviceCertificatesLinks [1]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-60 / Certificate Type (Technical Documentation, Type Examination, etc)
Description: When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.
Property defines the type of Product Certificate associate with the Device. | Occurrence: 1
Occurrence applicable if Device Certificate Inforamtion is provided (FLD-UDID-39) | Updateability: not stated | Referenced rules: BR-UDID-109
BR-UDID-110 | XML mapping: certificateType [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-61 / Certificate Number
Description: When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.
Property stores the Certificate Number of the Product Certificate | Occurrence: 0..1
Occurrence applicable if Device Certificate Inforamtion is provided (FLD-UDID-39) | Updateability: not stated | Referenced rules: BR-UDID-109
BR-UDID-110 | XML mapping: certificateNumber [3]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-343 / Certificates linked to the Device
Description: Reference to existing Certificates in EUDAMED linked to the current Basic UDI
Information is returned only when the Certificates are linked to the Device in EUDAMED . | Occurrence: 0..n | Updateability: not stated | Referenced rules: not stated | XML mapping: certificateLinks [4]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-344 / Certificate Number
Description: Certificate Number | Occurrence: 1
Occurrence applicable if Certificate Link is provided (FLD-UDID-343) | Updateability: (Upon the NB action from the Certificates module) | Referenced rules: not stated | XML mapping: certificateNumber [5]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-350 / Certificate Status
Description: Status of Certificates | Occurrence: 1
Occurrence applicable if Certificate Link is provided (FLD-UDID-343) | Updateability: (Upon the NB action from the Certificates module) | Referenced rules: not stated | XML mapping: certificateStatus [6]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
Dated technical/help evidence, not a complete legal duty set or live EUDAMED response. Current target-environment release, business rules, permissions and actual buyer records remain unresolved. Blank dictionary flags are unknown; occurrence and update notes keep their stated conditions. No credentials, registration deadline or completed production exchange is inferred.
Prepare the EUDAMED certificates work package
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Collect actual certificate evidence
Retain certificate type, issuing notified body, identifier, dates and scope from the underlying document.
Useful evidence: The current certificate and product/scope linkage evidence.
Separate supplied information from linked records
Reconcile registration metadata against the linked-certificate record and identify who controls each update.
Useful evidence: A metadata/link/owner reconciliation table.
Resolve mismatches through the responsible owner
Ask the provider which corrections belong to the manufacturer record and which require notified-body action or further validity checks.
Useful evidence: An ownership-specific correction plan and unresolved-scope/status list.
Work packages and dependencies
Conditional: EUDAMED certificates: registration metadata versus linked notified-body records — Review the actual current records and target-environment requirements; complete the specific mapping/onboarding or maintenance task with source/version and acceptance evidence.
Optional: Related preparation or maintenance support — Use only where the mapped records require that additional phase; confirm ownership and deliverables before adding this service.
Questions for providers
How will you resolve the specific field/identity or state dependencies shown here for our actual records?
Which current environment release, permissions and business rules support the proposed operation?
What mapping, unresolved-error and acceptance evidence will you hand over, and who owns each correction?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
