Medical device manufacturers must prioritise translation best practices
MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Device Regulation) are European Union laws that regularly update rules for medical devices, with MDR covering general devices (implants, crutches) and IVDR focusing specifically on devices used to test samples outside the body (blood tests, pregnancy kits). Both aim for higher safety, performance, traceability (UDI), and transparency, requiring stricter clinical evidence, notified body oversight (for higher-risk items), and continuous post-market surveillance, but vary in device scope, classification (MDR: Class I-III; IVDR: Class A-D), and specific evidence types (Clinical Evaluation vs. Performance Evaluation).
Regulatory expectations around MDR/IVDR are constantly increasing and translation has become more than a linguistic task, as it’s now a vital compliance, risk, and quality control tool for manufacturers. As the regulatory situation becomes increasingly complicated, companies must ensure that every translated document, whether a label, IFU (Instructions for Use), or technical file, meets strict linguistic, cultural, and legal standards. Failing to do so can result in costly delays, compliance breaches, or even product recalls, making translation compliance and project management an essential component of any MDR/IVDR readiness plan.
Why MDR/IVDR is of vital importance and future considerations
EU regulation amendments mean that medical device and IVD manufacturers must consider new and more stringent translation requirements. Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), manufacturers must provide device-related documents (e.g. IFUs, labels, technical documentation) in the official languages of each EU Member State where the device is marketed.
These translation requirements are non-negotiable, as missing or incorrect translations may cause delays in conformity assessments, regulatory rejections, usability, or safety risks. As the MDR/IVDR administration develops, translation workflows must be clearly auditable and flexible.
Maintain multilingual terminology & style guides
Inconsistent terminology or style across documents (IFUs, DoCs, labels) introduces confusion during the translation process. Establish a glossary and term base covering key regulatory and clinical terms and complement with international regulatory vocabularies such as EUDAMED nomenclatures. It is also important that all translators and reviewers can access and update the same style guides, as a well-maintained terminology system decreases potential future amendments, speeds up the review process, and enhances auditability.
Transparent multi-step review & in-country validation workflow
Translations must be accurate, culturally correct, and consistent with national regulatory requirements. Avoiding an extensive review or relying solely on local partners can cause delays or major inconsistencies.
For high-risk medical devices, consider adding a clinical subject-matter expert and/or native-speaking regulatory reviewer. Review tools such as track changes, comments, and side-by-side display are effective as well.
Always plan for change, as translation for MDR/IVDR is never a one-and-done exercise. As devices constantly modernise, labelling is also updated, standards alter, and regulatory guidance is revised. Therefore, your translation workflow must always remain flexible.
Collaborate with a specialist MDR/IVDR translation service provider
Utilising the services of a general translation agency or non-specialist freelancer may result in critical errors in regulatory nuance, medical terminology, or regional conventions. Collaborating with a specialist medical and life science translation agency such as Biomedica Translations will safeguard your compliance risk and allow your employees to focus on device manufacturing and meeting regulatory requirements.