UDI and EUDAMED Translation for Structured MDR Data

EUDAMED translation is the specialised translation of structured regulatory content registered or maintained in the European Database on Medical Devices. It typically covers device descriptions, intended purpose wording, nomenclature-related terms, Basic UDI-DI and UDI-DI records, product-family data, manufacturer information and other structured fields. Translations must accurately and consistently reflect approved source content with controlled medical device terminology and version alignment to surrounding documentation. AbroadLink delivers EUDAMED translation with qualified medical device linguists, ISO-based processes and risk-based workflow selection tailored to data field, device context and the sensitivity of each record type.

UDI localization is the multilingual adaptation of Unique Device Identification content into the languages required by EU markets where devices are placed. It covers Basic UDI-DI and UDI-DI fields, device descriptions, intended purpose wording, nomenclature-related terms and supporting structured information attached to UDI records. UDI localization requires controlled medical device terminology, product-family consistency and alignment with IFUs, labelling and technical documentation. AbroadLink supports UDI localization with qualified medical device linguists, translation memories, glossaries and risk-based workflow selection appropriate to the field type and the regulatory sensitivity of the content.

Multilingual UDI content refers to Unique Device Identification and related EUDAMED data produced and maintained in multiple languages to support EU market access. It typically includes translated device descriptions, intended purpose statements, nomenclature-related terms and other structured fields linked to Basic UDI-DI and UDI-DI records. Multilingual UDI content must remain consistent across repeated records, product families and related device variants, and aligned with IFUs, labelling and technical documentation. AbroadLink supports multilingual UDI content with structured-data awareness, medical device terminology control and risk-based workflow selection across languages and updates.

EUDAMED data translation is the translation of structured fields and records used in the European Database on Medical Devices. It typically covers device descriptions, intended purpose wording, manufacturer information, product-family data, nomenclature-related terms and supporting content used to register and maintain devices in EUDAMED. Translations must be accurate, consistent across repeated fields and aligned with the manufacturer's wider regulatory documentation. AbroadLink delivers EUDAMED data translation with qualified medical device linguists, controlled terminology, structured-data handling and risk-based workflow selection that reflects the sensitivity of each field type.

No. This is central to our risk-based approach. The accuracy objective for UDI localization and EUDAMED translation does not change with field type, record size or workflow choice. Lower-risk workflows apply leaner review steps to content where translation risk is lower, such as repeated or administrative fields, while still aiming for accurate, consistent and source-faithful translation. Higher-risk workflows add independent revision under ISO 17100 and other controls to reduce the probability and consequences of translation error in intended purpose wording, device descriptions and authority-facing records. Accuracy stays the constant objective.

AI can support EUDAMED data translation only as a controlled pre-translation step inside a workflow with qualified human review. Through aiHubLink, AbroadLink connects generative AI models with client terminology and previous approved translations, then applies medical device linguist review under ISO-based processes. For intended purpose wording, device descriptions, nomenclature-related terms and authority-facing records, AI output is treated as a draft, not a finished record. The client remains responsible for UDI strategy, EUDAMED registration, data validation and regulatory decisions. AI is positioned cautiously: useful where suitable, never a substitute for qualified human review.

No. Translation is one input into a broader UDI and EUDAMED process. AbroadLink delivers accurate UDI localization and EUDAMED translation, applies risk-based workflows, uses controlled medical device terminology, provides traceable certificates through CertLink and supports your QMS with documented processes. However, the manufacturer remains responsible for UDI strategy, EUDAMED registration, data validation, device classification, regulatory decisions, authority interaction and final compliance. EUDAMED translation, UDI localization, multilingual UDI content and EUDAMED data translation are language-side contributions to your regulatory data, not substitutes for regulatory, data-management or product activities and decisions.

CertLink is AbroadLink's portal for accessing translation certificates linked to each project. For UDI localization, multilingual UDI content, EUDAMED translation and EUDAMED data translation, certificates record translator and reviewer identification, project codes, document references and processes applied. Regulatory Affairs Managers, UDI Coordinators and EUDAMED Specialists can search and download certificates as audit-ready evidence supporting QMS records, internal audits, notified body interactions and competent authority requests. CertLink does not replace EUDAMED acceptance, UDI compliance or data validation, which remain outside AbroadLink's scope. It provides traceable language-side evidence that complements your existing regulatory documentation.