Knowledge · Medical devices & IVD
MDR/IVDR-compliant translation of medical devices
What MDR and IVDR require for translations
The EU Medical Devices Regulation MDR (Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation IVDR (Regulation (EU) 2017/746) require instructions for use, labelling, safety-relevant information and parts of the technical documentation to be available in the official languages of the Member States in which a product is made available. Each Member State defines the specific language requirements at national level. Manufacturers, authorised representatives, importers and distributors are responsible for complete and correct translations.
Which documents need to be translated
Instructions for use (IFU)
Instructions for use and user information in the user's language.
Marking & labelling
Labels, packaging and safety-relevant symbols.
Software, app & eIFU
Surface texts and electronic instructions for use.
technical documentation
Conformity documents and parts of the technical documentation.
SSCP (implants & class III)
Summary of safety and clinical performance in the national languages.
Why in-house translation poses a compliance risk
“Our developer will translate that” or “our foreign subsidiary will handle it” may sound reasonable, but in regulated environments it is risky. Three pitfalls:
Liability & marketing authorisation
The manufacturer is liable for conformity and for the correct language version. Errors in the instructions for use can jeopardise the conformity assessment and may even lead to product recalls or withdrawal from the market.
Lack of an audit trail
Without a documented, qualified process, due diligence in translation cannot be demonstrated in an audit. “Done in-house” does not constitute verifiable quality assurance.
Terminology & safety
In safety-critical texts, precision is decisive. Inconsistent terminology or careless mistakes can result in misuse, with consequences for patient safety and liability.
Applicable standards and regulations
For medical devices and in vitro diagnostic devices, a complex framework of EU regulations and harmonised standards applies. These regulations determine which documents must be available in which language and in which format.
MDR: Regulation (EU) 2017/745
Medical Devices Regulation: Instructions for use, labelling and safety-related information in the official languages of the member states where the device is made available.
IVDR: Regulation (EU) 2017/746
In Vitro Diagnostics Regulation: analogous language and labelling requirements for IVDs, with its own risk classification A–D.
EN ISO 13485
Quality management system for medical devices is the framework within which the control of translated documents must also be demonstrable.
EN ISO 14971
Risk management: safety-critical wording in IFUs and labelling must be consistent with the risk analysis in every language version.
EN ISO 15223-1
Symbols for the labelling of medical devices reduce the amount of text, but still require linguistically correct accompanying information.
EN ISO 20417 & IEC 62366-1
Both the information to be supplied by the manufacturer (20417) and the usable, comprehensible user information (62366-1) are directly relevant to the translation.
Regulation (EU) 2021/2226: eIFU
Electronic instructions for use for certain products: more digital, version-controlled content and therefore increasing, recurring translation volumes.
Status as of July 2026; information without guarantee. For IVDs, additional specific labelling standards apply (including the EN ISO 18113 series). The currently applicable versions of the regulations and harmonised standards are authoritative.
Staying on top of deadlines and developments
- To benefit from the MDR transitional periods, a written agreement with a Notified Body had to be signed by 26 September 2024.
- By 31 December 2027: End of the transitional period for Class III and Class IIb implantable devices.
- By 31 December 2028: End of the transitional period for other product classes.
- Digital content (eIFU, portals, in‑app texts) is growing and with it the volume of translations.
- On 16 December 2025, the European Commission presented a proposal to revise the MDR and IVDR. It includes, among other aspects, a lower risk classification for certain products (medical software is to be assigned predominantly to class I), the removal of the previous five‑year maximum validity period of certificates, and an extended reporting deadline for serious incidents (30 days instead of 15). For products in direct contact with patients and end users, the obligation to provide translations remains in place. This is a proposal and has not yet entered into force.
Status as of July 2026; information without guarantee. The applicable EU regulations and the national language requirements of the respective target markets are authoritative.
Medical device translations that stand up to scrutiny in an audit
From instructions for use to technical documentation, in line with ISO 17100 processes, with specialised translators and traceable quality assurance.
An audit-ready translation process at COMLOGOS
COMLOGOS translates medical device documentation in compliance with ISO 17100 processes (certified): Specialised translators with a medical-technical background, a binding four-eyes principle and consistently maintained terminology and clear documentation of every step in the translation process. Where artificial intelligence adds value, we use it in a controlled way with human post-editing in accordance with ISO 18587 (certified). Industry context: Medical technology and Pharmaceuticals & Chemicals, and for medicinal products rather than medical devices: GMP-Compliant Translation.
Technologies used
Frequently asked questions about MDR/IVDR-compliant translations
Do instructions for use of medical devices need to be translated?
Yes. MDR and IVDR require that the instructions for use, labelling and safety-relevant information are available in the official languages of the Member States in which the product is placed on the market. Each Member State defines the specific language requirements at national level.
Which documents fall under the translation requirement?
Primarily the instructions for use (IFU), the marking and labelling, software and app interfaces, including electronic instructions for use, as well as parts of the technical documentation. For implantable devices and Class III products, the Summary of Safety and Clinical Performance (SSCP) is also required.
Can the translation be done internally or by the foreign subsidiary?
The regulations do not specify who is responsible for carrying out the translation. However, the manufacturer is liable for the correctness of the content. Without a qualified, documented process, you cannot demonstrate due diligence during audits, and errors in safety‑relevant texts can jeopardise compliance. A certified process in accordance with ISO 17100 reduces this risk.
What does an audit-proof translation process involve?
A process whose quality can be demonstrated during audits: Specialised translators with a relevant background, a binding four-eyes principle in accordance with ISO 17100, maintained terminology and documented traceability of the processing steps.
What deadlines apply to MDR and IVDR?
Under the MDR, legacy devices may still be placed on the market, depending on their risk class, until 31 December 2027 (Class III and Class IIb implantable devices) or 31 December 2028 (other classes), provided that, among other things, an agreement with a Notified Body was signed by 26 December 2024. Under the IVDR, separate, staggered deadlines apply: 31 December 2027 (Class D), 31 December 2028 (Class C) and 31 December 2029 (Class B and Class A sterile). The applicable regulations in force at the time are decisive; the information is provided without guarantee.
Are medical device translations allowed to be produced using AI?
Artificial intelligence can support the process when it is used in a controlled manner and combined with human post-editing in line with ISO 18587. Qualified human expert review and documented quality assurance remain essential, particularly for safety-relevant content.
Which standards are relevant for MDR/IVDR compliant translations?
In addition to the MDR (EU) 2017/745 and IVDR (EU) 2017/746 regulations, the harmonised standards are particularly relevant: EN ISO 13485 (quality management), EN ISO 14971 (risk management), EN ISO 15223-1 (symbols), EN ISO 20417 (information to be supplied by the manufacturer) and IEC 62366-1 (usability). For electronic instructions for use, Regulation (EU) 2021/2226 also applies. For the translation itself, we work in accordance with ISO 17100 using the four-eyes principle; where AI support is used in a controlled manner, human post-editing in line with ISO 18587 is added. This ensures that the language version remains consistent with risk analysis, labelling and technical documentation. The information is provided without guarantee; the applicable versions in force are binding.
What our clients in the pharmaceutical and medical technology sectors say
Regulated, review-required specialised translation, validated by manufacturers from the pharmaceutical and medical technology sectors.
"For many years, we have been relying on COMLOGOS’s competent support for regulatory translations. We particularly value the high quality of the translations, the reliability and the flexibility when working to demanding schedules. The professional and straightforward collaboration gives us confidence that even time-critical projects are completed on schedule and to a high professional standard."
"We are very satisfied with the fast and straightforward processing of our orders and with the friendly and competent support from our team. Our complex medical texts are translated with a high level of professionalism and care. We appreciate the ongoing collaborative partnership with COMLOGOS.
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