Medical devices help people no matter what language they speak or where they live. However, medical device manufacturers must follow strict regulations to be able to offer their products globally. These requirements include the EU Medical Device Regulation (MDR) and the EU In vitro Diagnostic Regulation (IVDR). Read this article to find out what is the expanded scope of medical devices and how to navigate the world of MDR- and IVDR-compliant translations.

The EU MDR, which went into effect in May 2021, replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). It aims to improve the safety and performance of medical devices by introducing stricter requirements for market access, clinical evidence, and post-market surveillance.

The EU IVDR, which was updated in January 2022, replaces the In vitro Diagnostic Device Directive (IVDD) and brings similar changes as the EU MDR for in vitro diagnostic medical devices. It lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the EU.

MDR and IVDR alike require manufacturers to provide translations of instructions (such as labelling, the instructions for use (IFU) or product claims) in the official languages of the EU member states where the device will be sold. These translations must be accurate and consistent with the original text, and they must be reviewed and approved by a qualified person before being released to the market. They also need to be kept up-to-date.

Expanded scope of Medical Devices under the EU MDR

It is important to know which devices fall under the new requirements. The term „medical devices” in accordance with the EU MDR means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for people for the purpose of:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease

• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability

• Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Medical devices range from simple bandages to complex surgical instruments and implants, in vitro diagnostic products, imaging systems, medical robots, and software. The scope of the term “medical devices” includes also custom-made medical devices, active implantable medical devices, medical devices with integrated software, and any accessories to such devices. Included are also devices used for the control of conception, such as contraceptives, as well as certain home-use medical devices, such as self-testing and self-monitoring medical devices.

Navigating the World of MDR- and IVDR-compliant Translations

Here are a few tips for managing the translation process for medical devices to meet the requirements of the EU MDR and EU IVDR:

1. Establish a dedicated team: Form a dedicated team responsible for managing the translation process, including project management, translation, and quality control. This team should be composed of individuals with expertise in both medical device regulations and translation.
2. Implement a Translation Management System (TMS): Use a TMS to streamline the translation process and ensure consistency across all translations. A TMS can also facilitate collaboration among team members and provide real-time translation progress tracking.
3. Establish a terminology management system: Implement a terminology management system to ensure consistency in the use of technical terms and phrases across all translations.
4. Develop a Quality Management System (QMS): Develop a QMS to ensure the quality of the translations. This should include a system for reviewing and approving translations, as well as a process for addressing any errors or inconsistencies.
5. Perform regular audits: Schedule regular audits of the translation process to ensure compliance with the EU MDR and EU IVDR requirements and to identify areas for improvement.
6. Continuously improve: Continuously review and improve the translation process, including the use of new technologies and industry best practices, to ensure compliance with any new regulations and to improve the overall quality of translations.
7. Consider using professional medical translators with relevant medical device experience and certifications.

Getting headaches already?

Leave them to Studio Gambit, your one-stop shop for streamlined translation management. By partnering with Studio Gambit, medical and pharmaceutical companies can get the help they need to get certified in accordance with the European Union Medical Device Regulation. We understand the importance of accuracy and precision when it comes to medical and pharmaceutical documents, so you can rest assured that our team of professionals will get the job done right. Contact us today to learn more about how we can help you get MDR and IVDR certified.