Medical Devices
Compliance with medical device industry regulations
In May 2021 the EU Medical Devices Regulation (MDR – 2017/745/EU) became binding, replacing the earlier Medical Devices Directive (MDD – 93/42/EEC). Provisions for in vitro diagnostic devices under Directive 98/79/EC (IVDD) were also replaced with the more detailed IVDR 2017/746/EU. A new requirement under these regulations is the provision of translated IFUs (Instructions for Use) both on the manufacturer’s website and in the EU EUDAMED database. Along with the IFU manufacturers must also provide, among other things, information on when the device should no longer be reused, detailed instructions, warnings or precautions for safe disposal of the device, as well as a warning to remind users to report any serious incident connected with the device.
Examples of documents requiring translation
- Medical device instructions for use
- Safety data sheets
- Descriptions of sterilisation methods
- Declarations of conformity
- Medical software
- Medical device labelling
- Descriptions of manufacturing technologies, design drawings, test results and validation data
- Risk analysis reports
- Design calculations and study results including compatibility with other devices
- Clinical evaluation reports
- Lists of applied harmonised standards
- Labels and IFUs
- Promotional materials
Translations of instructions for use
Accurate translation of instructions for use requires both medical and technical expertise so that the translator fully understands how a particular medical device functions. At Omero we know that native-level mastery of both source and target languages is also essential to adapt the content for the user and ensure proper localisation. Our project managers select translators according to the target audience’s level of technical knowledge and experience (e.g. instructions for devices intended for doctors or patients).
Translation certification
Medical device documentation translations are carried out both for entities operating in the EU market and for those outside the EEA acting through authorised representatives. All materials entrusted to us are subject to strict confidentiality and information security procedures, confirmed by our ISO 27001:2017 certification. Translations are performed in line with ISO 17100:2015 and quality is verified by a Certification of Translation Accuracy.