Regulation (EU) 2017/745, the MDR, placed concrete language obligations on manufacturers, authorised representatives, and importers operating in the European market. Obtaining or maintaining CE marking for a medical device requires correctly translated supporting documentation, in the right format, at a level of rigour proportionate to the device's risk classification.
What the MDR requires on translation
The MDR does not prescribe a specific translation process, but it sets clear functional requirements. Article 10 requires manufacturers to draw up technical documentation in accordance with Annexes II and III. Article 7 prohibits misleading claims about the device, including those arising from inaccurate translations. Article 32 requires the Summary of Safety and Clinical Performance (SSCP) to be made available in the official languages of the Member States where the device is placed on the market.
The standard approach for regulatory submissions is this: the working language of the technical file is English, but any document accompanying the device for the end user, including instructions for use (IFU), labelling, and clinical summaries, must be in the language of the country of placement. There is no room for ambiguity: the European Commission and notified bodies expect terminological consistency across the technical documentation, labels, and IFUs.
Which documents require certified or qualified translation
Not all documents in the CE marking process require the same level of formality in translation. Three categories are worth distinguishing:
Technical and clinical evaluation documentation: The Clinical Evaluation Report (CER), Post-Market Clinical Follow-up (PMCF) reports, and risk analysis are internal documents submitted to the notified body. The requirement here is terminological precision, not necessarily formal certification. These documents must be translated by specialists familiar with standards such as ISO 14971 and MEDDEV 2.7/1.
Instructions for use and labelling: Annex I, point 23 of the MDR specifies the language requirements for IFUs and labels. The translation must be accurate, consistent with the source, and validated for the target market. Translation errors in these documents can constitute serious non-conformity and trigger recalls. The approach to medical device documentation under the MDR follows the same zero-tolerance logic applied to drug labelling: imprecision is not an acceptable outcome.
Summary of Safety and Clinical Performance (SSCP): This document is public, accessible in the EUDAMED database, and must be available in all relevant official EU languages. It is the most publicly visible document in the technical file and where translation errors have direct consequences for how the device's safety profile is perceived.
Critical language pairs and high-risk markets
The priority markets for medical devices in Europe are Germany, France, Italy, Spain, the Netherlands, and Portugal. Each requires its own language on documents addressed to the end user. The most relevant notified bodies under the MDR, including TÜV SÜD, BSI, and DEKRA, have review teams that detect terminological inconsistencies between language versions.
Certain language pairs carry higher error risk: English to German in medical software terminology, English to European Portuguese in in-vitro diagnostic devices, and English to French in surgical documentation. This is due to the specific terminological density of each area and the existence of complementary national standards.
For those preparing submissions to a notified body, it is worth knowing that a complete technical file covers not just the primary texts but also technical annexes, declaration of conformity templates, and updated versions following design changes or revised indications for use.
Factors that affect cost and timeline for regulatory translation
The cost of a translation project for MDR registration depends on several variables. Document volume is the most direct factor: a complete technical file for a class III device can run to thousands of pages. The language combination determines the availability of qualified specialist translators and the time required. Urgency has a significant impact: a tight submission deadline requires larger teams and parallel workflows.
The level of process formalisation also affects investment. A translation produced under an audited ISO 17100 process, with independent review and documented quality control, differs from a single-reviewer translation. For documents submitted to notified bodies, the level of traceability required justifies the investment in an audited process: errors or inconsistencies can delay certification by months.
Translation memory management and manufacturer-specific glossaries are another determinant. Maintaining terminological consistency between the initial submission, regulatory updates, and post-market documentation requires a linguistic asset management system that must be built and maintained across the device lifecycle.
How M21Global supports MDR registration projects
M21Global has direct experience in translation projects for regulatory submissions in the medical device sector, covering technical documentation, IFUs, SSCPs, and correspondence with notified bodies. Translation for regulatory documentation follows an ISO 17100-audited workflow with three linguists, client-specific glossary management, and full process traceability. The pharmaceutical and regulatory translation services cover the language pairs most in demand across the European regulatory landscape, with specialist teams versed in MDR terminology and harmonised standards.
To assess the scope and the right process for a specific device registration, the most useful step is to submit the documentation for an initial review. Contact M21Global to discuss your project requirements and receive a proposal tailored to the device profile and target markets.
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Frequently Asked Questions
Does MDR 2017/745 require translation of all technical documentation?
Not in absolute terms. Internal technical documentation submitted to the notified body is generally accepted in English. The strict language obligation applies to documents addressed to the end user, such as IFUs and labelling, and to the SSCP, which must be available in the official languages of the Member States where the device is marketed.
What is the SSCP and how many languages does it need to be in?
The Summary of Safety and Clinical Performance is a mandatory public document for class III devices and implantable devices. It must be available in EUDAMED in the official EU languages corresponding to each country where the device is placed on the market.
Is certified translation required for notified body submissions under the MDR?
Formal certification is not an explicit MDR requirement, but notified bodies expect documentation translated with terminological rigour and demonstrable consistency. A translation produced under an audited ISO 17100 process provides the level of traceability and quality that supports the submission and facilitates subsequent audits.
Which MDR documents carry the greatest translation risk?
Instructions for use, labelling, the SSCP, and the EU declaration of conformity carry the highest regulatory exposure. Translation errors in these documents can constitute serious non-conformity before competent authorities and may trigger market withdrawal procedures.
How is terminological consistency maintained across language versions?
Consistency is maintained through manufacturer-specific glossaries and translation memories managed across the device lifecycle. This linguistic asset becomes especially important when regulatory updates, design changes, or new indications for use require documentation revisions.
