Since the full application of Regulation (EU) 2017/745 — the MDR — the translation of medical device technical documentation has become a concrete regulatory requirement, not an administrative formality. Manufacturers and authorised representatives placing devices on EU markets must ensure that all mandatory documentation is available in the official language or languages of each Member State where the device is marketed — and that those translations meet verifiable standards of accuracy, consistency, and traceability.
What the MDR Requires from Translation
Regulation (EU) 2017/745 sets out in Annex I (General Safety and Performance Requirements) and Annexes II and III (Technical Documentation) that information intended for users — instructions for use (IFU), labelling, and safety data sheets — must be written in the official language or languages of the Member State where the device is placed on the market.
The documents most commonly requiring translation under the MDR include:
- Instructions for Use (IFU): mandatory in paper or electronic format (eIFU) for all devices in Classes I, IIa, IIb, and III
- Labelling: primary and secondary packaging, including normative symbols (ISO 15223-1)
- EU Declaration of Conformity: formal document issued by the manufacturer
- Summary of Safety and Clinical Performance (SSCP): mandatory for Class IIb and III devices; made publicly available via EUDAMED
- Technical documentation: clinical evaluation reports, risk analyses (ISO 14971), post-market surveillance plans
- Safety Data Sheets (SDS): for devices with relevant chemical components
The SSCP deserves particular attention: it must be validated by the Notified Body and published in EUDAMED in an official EU language — typically English — with translated versions made available for each market where the device is distributed.
Quality and Traceability Requirements for MDR Translation
MDR compliance does not accept unreviewed machine translation or processes without documentary traceability. Notified Bodies — including TÜV, BSI, and DEKRA — assess technical documentation and verify terminological consistency across language versions. An IFU with translation errors or inconsistent terminology can result in a non-conformity finding during audit.
The practical quality requirements for MDR documentation translation are:
- Translators specialised in medical devices: with working knowledge of clinical and regulatory terminology (MDR, IVDR, applicable ISO standards)
- TEP process (Translation, Editing, Proofreading): independent review by a second qualified translator
- Terminology management: controlled glossaries per device and product line, ensuring consistency across documents and versions
- ISO 17100:2015 certification: the international standard defining requirements for translation service providers — directly recognised in regulatory audit contexts
- Traceability: version control, revision records, and translation memories that allow the process to be audited
ISO 17100 is particularly relevant because it defines the minimum translator profile, the review process, and project management requirements — precisely the evidence a Notified Body may request to verify quality.
Language Pairs, Volumes, and Timelines: Key Considerations
Distributing a medical device across multiple Member States means, in practice, translating documentation into a significant number of European languages. The most common pairs from English or German — the dominant technical documentation languages — include Portuguese, Spanish, French, Italian, Polish, Dutch, and Swedish, among others.
Factors that determine the effort and timeline for an MDR translation project:
- Document volume: a full IFU for a Class III device may contain between 10,000 and 40,000 words; an SSCP between 5,000 and 20,000
- Number of languages: multilingual projects require centralised coordination to maintain terminological consistency across versions
- Regulatory updates: changes to labelling, IFU, or SSCP following audit findings or post-market surveillance generate a need for rapid incremental translation
- File formats: documents in InDesign, FrameMaker, XML, or DITA require DTP and localisation engineering skills beyond pure translation
Update management is a critical point: the MDR requires that translated versions always reflect the approved version of the source document. A provider with active translation memories significantly reduces the cost and turnaround time of ongoing updates.
M21Global: Certified Translation for MDR Compliance
M21Global holds ISO 17100:2015 certification (Bureau Veritas) and ISO 18587, with translators specialised in medical device documentation — including IFU, regulatory labelling, clinical evaluation reports, and SSCP. With over 300 million words translated and 20 years of experience in technical and regulatory translation, the company manages multilingual projects with full traceability, in line with the standards Notified Bodies verify during audit. Request a quote for your MDR documentation translation and receive a detailed proposal within 24 hours.
Frequently Asked Questions
Does MDR 2017/745 require IFU translation into every language of the countries where the device is sold?
Yes. Regulation (EU) 2017/745 requires that instructions for use are available in the official language or languages of the Member State where the device is placed on the market. Non-compliance can result in a non-conformity finding during a Notified Body audit.
What is the SSCP and in which languages must it be available?
The Summary of Safety and Clinical Performance (SSCP) is a mandatory document for Class IIb and III devices, validated by the Notified Body and published on EUDAMED. It must be available in an official EU language and, typically, in translated versions for each market where the device is distributed.
Is machine translation acceptable for medical device documentation under the MDR?
Unreviewed machine translation is not acceptable in MDR regulatory contexts. Notified Bodies assess terminological consistency and accuracy across translated versions; a process with qualified human review and documentary traceability is required.
Why is ISO 17100 certification relevant for MDR documentation translation?
ISO 17100:2015 defines quality requirements for translation service providers — translator qualifications, review process, and project management — and is recognised as evidence of quality in regulatory audit contexts, including medical device documentation.
How are translation updates managed when technical documentation changes after initial certification?
With active translation memories, only changed segments require retranslation, reducing cost and turnaround time. The provider must ensure translated versions always reflect the approved source document version, with documented version control.
