Medical Device Manufacturers
Why Translation Is a Regulatory Requirement, Not a Service Choice 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:
EU MDR — Regulation (EU) 2017/745 on Medical Devices 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. EU IVDR — Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices 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: Official Language of the Member State 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.
Article 10(11) of EU MDR states that manufacturers shall ensure that the device is accompanied by the information set out in Annex I, Section 23 — which covers labelling and instructions for use
— in the official language(s) accepted by the member state in which the device is made available to the user or patient.
In practice this means: A device marketed in Germany requires documentation in German A device marketed in France requires documentation in French A device marketed in Spain requires documentation in Spanish A device marketed across all EU member states requires documentation in all official EU languages
EU official languages covered by this requirement include: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian,
Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, and Swedish. This is 24 languages for full EU market coverage. 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 IFU is 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 (discussed below), but for most devices the IFU is a hard translation requirement.
The IFU must include all information specified in Annex I, Section 23.4 of EU MDR, including: Intended purpose and indications for use Contraindications and warnings Precautions and foreseeable risks Instructions for preparation, installation, operation, maintenance, and storage Performance characteristics where relevant Information about residual risks and undesirable side effects Reference to the declaration of conformity Contact information for the manufacturer and authorized representative All of this content must be translated. Partial IFU translation — translating some sections but not others — does not satisfy the requirement. Labelling Device 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:
Device name and model identifier Intended purpose (brief) Manufacturer name and address Authorized representative name and address (for non-EU manufacturers) Lot number, serial number, or unique device identifier (UDI) Date of manufacture and/or expiry date Warnings and precautions Storage and handling conditions Sterilization indicator where applicable 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 Declaration of Conformity (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 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 a Summary of Safety and Clinical Performance (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. It applies only where: The device is intended solely for professional use — not for any direct patient use or self-testing There is a reasonable basis for the assumption that healthcare professionals in the target market can read the relevant language (typically English)
The relevant national competent authority in the member state accepts this approach
It does not apply to: Consumer or patient-facing devices of any class Self-testing devices Devices used by patients or non-professionals in any context Labelling (labelling language requirements apply regardless of the professional use exception) The professional use exception should be treated as a risk management decision, not an automatic entitlement. Several EU member state competent authorities have indicated strict interpretation of this exception. Manufacturers relying on it should document the basis for the exception in their technical file and confirm its acceptability with their notified body and the relevant national authorities.
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.
For Class I devices (lower risk), conformity assessment may be conducted without notified body involvement, and translation errors may surface only through market surveillance or user complaints. The absence of a notified body review does not reduce the legal translation obligation.
For Class IIa, IIb, and III devices (higher risk), the notified body reviews documentation — including the IFU and labelling — as part of the conformity assessment. A notified body will identify missing language versions and documentation that does not meet language requirements, and may not certify a device until deficiencies are corrected.
For Class III implantable devices, the SSCP requirement adds a further translation obligation that does not apply to lower-risk classes. 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:
The device must not be intended for use in home healthcare environments The user must be a healthcare professional A paper version must be available on request at no cost The eIFU must be accessible via a website address on the label Certain information must still be provided on the label in paper form 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.
United Kingdom 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.
United States 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.
Canada 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.
Japan The PMDA (Pharmaceuticals and Medical Devices Agency) 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.
China The NMPA (National Medical Products Administration) 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.
Australia The TGA (Therapeutic Goods Administration) 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 Medical Device Translation Translator Qualifications 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 regulatorygrade accuracy requirements.
Under ISO 17100:2015 — the international standard for translation services — translators must have subject-matter competence in the relevant domain. For regulated medical device documentation, this means demonstrating knowledge of: Medical terminology in the target language
The regulatory terminology conventions of the relevant market The document type being translated (IFU, labelling, clinical evaluation, SSCP) Revision and Quality Assurance 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.
Terminology Management 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. Translation Memory 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. Version Control and Update Management 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. Certificate of Translation 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: Which member states will the device be marketed in at launch, and which may follow? This determines the initial language program scope and allows planning for subsequent language additions.
Does the professional use exception apply to any document types? If so, which member states' competent authorities will accept the exception, and is this documented in the technical file?
What is the IFU delivery format — paper or eIFU? eIFU is not available for all device types. If eIFU is applicable, the translation and hosting infrastructure for electronic IFU must be established.
What is the update frequency for the IFU and labelling? 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.
What is the timeline from source IFU finalization to CE marking? 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.
Who will manage terminology consistency across 24 language versions? 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.
Summary: What Compliant Medical Device Translation Requires IFU and labelling in the official language(s) of every EU member state where the device is marketed — this is a legal requirement, not an option
Translators with documented medical device and life sciences subject-matter expertise Mandatory revision by a second qualified linguist before regulatory submission Maintained terminology database applied consistently across all document types and language versions
Translation memory for efficient management of document updates Version control ensuring translated documents remain synchronized with source document versions
Certificate of translation where required by the notified body or competent authority SSCP translation for Class III implantable devices Working With 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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