Terminology (Term Management)
Terminology, in the translation context, refers to the systematic capture, management, and maintenance of technical terms and their approved translations in a terminology database. Consistent terminology ensures that identical concepts are rendered with the same terms across all language versions of a document. In the medical device sector, this is particularly critical, as ambiguous or inconsistent terms can lead to use errors and safety risks.
When translating medical device IFUs, terminology must be assured not only linguistically but also from a regulatory perspective. Terms from harmonised standards and the EU MDR must be used in their official translations.
Frequently Asked Questions
Why is uniform terminology so important in IFU translation?+
Inconsistent terminology in instructions for use can lead to misuse and poses a safety risk for patients and users. Regulatory requirements under EU MDR Annex I Chapter III mandate clear, unambiguous language. A central terminology database ensures that technical terms are used uniformly and correctly across all language versions.