MDR医疗器械法规
MDR is the European Union regulation that sets requirements for placing medical devices on the EU market, including classification, technical documentation, and post-market surveillance. It replaced the Medical Devices Directive and imposes broader obligations on economic operators; in translation and localization, it drives updates to labels, instructions for use, declarations of conformity, and vigilance content across EU languages for each member state.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
MDR appears in EU market-access projects where manufacturers update technical files, labels, IFUs, and post-market surveillance documents. Translators work with notified-body feedback and language variants for each member state, often aligning terminology across multiple official languages while preserving regulatory intent, usability requirements, and consistency with the source technical documentation from the manufacturer.
Translation checks
A common mistake is treating MDR as a single document that only affects labels; it also changes technical documentation, clinical evidence, and post-market obligations. Translators sometimes retain legacy directive terminology or country-specific wording that conflicts with current requirements, creating inconsistencies that notified bodies may flag during review of the technical file.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.