EU MDR Technical File & CER Multilingual Program
Translated MDR technical files, clinical evaluation reports and PMCF plans for a Class IIb device with notified body review.
Background
A client migrating CE certification to MDR needed upgraded MDD materials in EN/DE—GSPR mapping, risk management, clinical evaluation and post-market surveillance files.
Outcomes
Zero translation-related findings in NB first-round queries; supplements submitted on time
Services:
Languages:
Project challenges
MDR requirements
Accurate GSPR and PMCF language.
Large CER
Literature citations and data tables formatted consistently.
NB tone
Language aligned with notified body expectations.
Cross-references
Section numbering and reference chains intact.
Our approach
Phased delivery balancing quality, compliance and timeline.
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
Deliverables
Project highlights
MDR migration
MDD→MDR structure upgrade support.
CER expertise
Clinical data and citation accuracy.
German NB
German notified body phrasing.
Cross-refs
Full reference chain QA.
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