For most organizations, translation is a business decision - they choose to translate content because it helps them reach more markets or communicate more effectively. For medical device manufacturers, translation of certain documentation is not a business decision. It is a legal obligation.
A device marketed in Germany without German-language documentation is not simply a missed opportunity - it is a regulatory violation.
This distinction matters because it changes how translation should be approached. A business decision can be made on cost and convenience. A regulatory obligation must be met accurately, completely, and in a way that can be documented and audited. The consequences of non-compliance range from market access denial to product recall, and in cases involving patient safety, to regulatory action against the manufacturer.
This guide explains the translation requirements that medical device manufacturers face when accessing EU markets, what those requirements mean in practice, and how to structure your translation program to meet them reliably.
The EU Regulatory Framework for Medical Devices
The European Union's medical device regulatory framework is governed by two primary regulations:
Covers most medical devices - surgical instruments, diagnostic equipment, implants, monitoring systems, and a broad range of other devices. MDR replaced the former Medical Devices Directive (MDD) and In Vitro Diagnostic Directive (IVDD), with a transition period that ended for most device classes in May 2024.
Covers in vitro diagnostic devices - test kits, analyzers, reagents, and instruments used for examining specimens derived from the human body. IVDR phased in requirements progressively, with most higher-risk IVDs requiring full compliance from 2025-2027.
Both regulations are directly applicable across all EU member states - they do not require national transposition and their requirements are uniform across the EU. They apply to any manufacturer, regardless of location, who wishes to place devices on the EU market.
The Core Language Requirement
The fundamental translation requirement under both EU MDR and EU IVDR is straightforward: information supplied with a device must be provided in the official language or languages of the EU member state or states where the device is made available.
Manufacturers who plan EU-wide distribution must plan for 24-language translation programs - not as an optional enhancement, but as a regulatory baseline.
What Documentation Must Be Translated
Not all documentation associated with a medical device has the same translation requirement. Understanding which documents require translation, at what level of completeness, and in what timeframe is essential for planning a compliant translation program.
Instructions for Use (IFU)
The primary document subject to mandatory language requirements. It must be provided in the official language(s) of each member state where the device is made available. There are limited exceptions for certain professional-use devices, but for most devices the IFU is a hard translation requirement.
All of this content must be translated. Partial IFU translation - translating some sections but not others - does not satisfy the requirement.
Labelling
The information on or accompanying the device packaging must be in the official language(s) of the member state(s) where the device is placed on the market. This includes:
Labelling presents specific translation challenges because it is constrained by physical space. Text expansion in translation - German and Finnish text is typically 30-40% longer than equivalent English text - requires label design to accommodate translated content without truncation.
Declaration of Conformity
The DoC is the manufacturer's formal statement that the device meets all applicable regulatory requirements. Under EU MDR, the DoC must be made available in the official language(s) of the member states. This typically means providing the DoC in all EU languages for devices with broad market access, or at minimum in the language(s) of the specific member states where the device is marketed.
Technical Documentation
The comprehensive file demonstrating conformity is not required to be provided to end users, but it must be available to the relevant competent authorities and to the notified body. Requirements for the language of technical documentation vary by member state competent authority. Some authorities require technical documentation in their national language; others accept English.
Manufacturers should confirm the language requirements of the competent authority in each member state where they register or respond to queries, and prepare to provide technical documentation accordingly.
Post-Market Surveillance Documentation
Post-market surveillance (PMS) reports, periodic safety update reports (PSURs), and post-market clinical follow-up (PMCF) documentation are primarily internal documents submitted to notified bodies and competent authorities rather than end-user documents. Language requirements depend on the receiving authority - confirm requirements with your notified body and the relevant national competent authorities.
Summary of Safety and Clinical Performance (SSCP)
For implantable devices and Class III devices, EU MDR requires the preparation of an SSCP - a publicly available document that must be available in the official EU languages relevant to the member states where the device is marketed. This is a new requirement introduced by MDR that many manufacturers are still implementing.
The Professional Use Exception
EU MDR and IVDR provide a limited exception to the IFU language requirement for certain professional-use devices. Under Article 10(11) of EU MDR, the requirement to provide information in the official language(s) of the member state(s) may be waived for devices intended to be used solely by healthcare professionals, if the manufacturer can demonstrate that the information can be provided to the healthcare professional in another language that is understood by the user - typically English.
This exception is narrower than it appears.
Translation Requirements by Device Class
EU MDR classifies devices into four risk classes - I, IIa, IIb, and III - and EU IVDR classifies IVDs into Classes A, B, C, and D. Language requirements are uniform across device classes, but the consequences of documentation failures escalate with device risk.
eIFU: Electronic Instructions for Use
EU Regulation 207/2012 permits manufacturers to provide IFUs in electronic format (eIFU) rather than in paper form, subject to conditions:
eIFU does not eliminate the language requirement. The electronic IFU must still be available in the official language(s) of the member states where the device is marketed. What eIFU changes is the delivery format and update mechanism - translated IFU content must still be present, but it can be hosted and updated electronically rather than printed with each device.
For manufacturers with complex, frequently updated IFUs distributed across many EU markets, eIFU combined with a well-managed translation workflow can significantly reduce the cost and complexity of keeping translated documentation current.
Non-EU Markets: Key Language Requirements
Beyond the EU, medical device manufacturers frequently target markets with their own distinct language requirements.
Post-Brexit, the UK operates its own regulatory framework under the MHRA (Medicines and Healthcare products Regulatory Agency). Devices for the UK market must have documentation in English. Northern Ireland has a more complex status. UK Responsible Person requirements apply to non-UK manufacturers.
The FDA does not mandate translation of device documentation into languages other than English for devices marketed in the US. However, for devices where labelling or IFU claims are made in other languages, those claims must also be reviewed. For devices exported from the US, the importing country's language requirements apply.
Health Canada requires bilingual labelling in English and French for devices marketed across Canada. This is a hard requirement, not an exception - all labelling must appear in both languages.
The PMDA requires device documentation in Japanese. Japan has detailed requirements for the format and content of Japanese IFUs, and translation must be produced by translators with specific pharmaceutical and device translation experience in Japanese regulatory contexts.
The NMPA requires device documentation in Chinese (Simplified). Chinese IFU requirements are detailed and specific, and translation must comply with the Chinese pharmacopoeia and medical device terminology standards applicable in mainland China.
The TGA accepts documentation in English for devices marketed in Australia. For devices also marketed in non-English-speaking markets, separate translated documentation is needed for those markets.
Practical Requirements for Compliant Translation
Medical device translation requires translators with documented expertise in both the target language and the relevant technical and regulatory domain. A translator without medical device or life sciences background cannot reliably produce translation that meets regulatory-grade accuracy requirements.
Regulatory documentation must be reviewed by a second qualified linguist before delivery. ISO 17100:2015 mandates this revision step - the reviser checks the translation against the source for accuracy, completeness, terminology consistency, and register. For medical device documentation submitted to regulatory authorities or notified bodies, revision is not optional quality enhancement - it is a process requirement.
Medical device documentation uses precise technical and regulatory terminology that must be consistent throughout all documents and across all language versions. A managed terminology database - containing approved translations for device names, technical terms, regulatory references, and safety language - is essential for maintaining this consistency across large document sets and multiple language versions.
For devices with extensive documentation that is updated over the product lifecycle, translation memory significantly reduces the cost and time of updating translated documents. When a section of an IFU is unchanged between versions, the approved translation is reused automatically. Only changed content requires new translation - with consistency against the unchanged surrounding text maintained by the TM.
Medical device documentation is subject to change - software updates, design changes, new clinical evidence, regulatory requirement changes. Each change that triggers a documentation update requires corresponding changes to all translated versions. A translation program without version control and update management will accumulate version discrepancies between the source and translated documentation, which is a regulatory compliance risk.
Some regulatory authorities and notified bodies require a formal statement from the translation provider confirming that the translation is accurate and complete. Confirm whether this requirement applies for each submission context and ensure your translation provider can provide appropriate documentation.
Planning Your EU Language Program
For manufacturers planning EU market entry across multiple member states, the language program should be planned as part of the regulatory strategy, not as a separate procurement exercise. Key questions to answer at the planning stage:
This determines the initial language program scope and allows planning for subsequent language additions.
If so, which member states' competent authorities will accept the exception, and is this documented in the technical file?
eIFU is not available for all device types. If eIFU is applicable, the translation and hosting infrastructure for electronic IFU must be established.
Higher update frequency increases the cost and complexity of maintaining translated versions. A translation memory and structured update workflow become more valuable as update frequency increases.
Translation of the IFU into multiple EU languages must be completed before CE marking, and the translated IFUs are part of the technical file reviewed by the notified body. Build the translation timeline into the overall conformity assessment schedule.
For a full EU language program, terminology management is not optional. A managed glossary applied consistently across all language versions is the mechanism that prevents terminology inconsistency across the full language set.
What Compliant Medical Device Translation Requires
Business Team Translations on Medical Device Documentation
Business Team Translations translates medical device documentation for manufacturers including 77 Elektronika, B.Well Swiss, 3DHISTECH, Roche, Medicontur, and others. Our medical device translation work covers IFUs, labelling, user manuals, clinical evaluation reports, SSCPs, and related regulatory documentation across all EU languages and selected non-EU markets including Arabic, Chinese, Japanese, and Persian.
All medical device translation is delivered under our ISO 17100:2015 certified process, with mandatory independent revision and maintained client-specific terminology databases. We translate into all 24 EU official languages.
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