EUDAMED sterility data: label-sterile and sterilise-before-use are separate fields
The acquired dictionary records labelled-sterile and need-for-sterilisation-before-use separately. Reconcile both against the supplied configuration and instructions; one flag does not establish the other or validate a sterilization process.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Description: Property defines if the UDI-DI is labeled as Sterile or not | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: sterile [1]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-170 / Need for sterilisation before use
Description: Property defines if the UDI-DI needs to be sterilised before use or not | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: sterilization [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-167 / Labelled as single use
Description: Property defines if the Device is a Labelled as a Single use or not | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: provided through numberOfReuses
If value provided is 0 for numberOfReuses, Device is considered as Single use Device
If value provided is <>0 numberOfReuses (-1 or any value > 0), Device is considered as not being Single use Device [3]
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 sterility data 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.
Identify each marketed configuration
Separate sterile/nonsterile presentations and their actual identifier/label evidence.
Useful evidence: A presentation-level DI and label inventory.
Reconcile both sterility questions
Record label-sterile status and preparation-before-use independently from current labels/instructions.
Useful evidence: A two-field source-of-truth matrix with unresolved conflicts.
Agree data corrections and evidence gaps
Ask the registration provider to resolve inconsistent flags; commission separate validation work only if its need is justified.
Useful evidence: A correction plan and any separately scoped validation questions.
Work packages and dependencies
Conditional: EUDAMED sterility data: label-sterile and sterilise-before-use are separate fields — 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.
