In May 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) were replaced and fully covered by the Medical Device Regulation (MDR), making MDR translations crucial to meet regulatory standards in the EU. The MDR brought many new changes, with it, challenges to medical device manufacturers attempting to gain access to the EU’s diverse market. Under the MDR, some changes companies saw include the formation of the European Databank on Medical Devices (EUDAMED) for greater responsibility of post-market surveillance as well as introducing Unique Device Identification (UDI) and Implantable Cards, expanding the definition of a medical device to include software and applications, medical device companies established a designated person for regulatory compliance, creating a summary of safety and clinical performance for Class III and implantable devices, and changes affecting notified bodies. In addition, there were no longer “grandfathering in” or “legacy” devices on the market; all current devices had to be redefined under the new MDR. With the transition period ending in 2025, medical device companies and manufacturers need to understand the changes in requirements for current devices in the EU’s market, as well as future medical device products, to not only save time and money but also for MedTech companies to be well-equipped for any further regulatory changes.
Just as the requirements for medical device manufacturers have changed and become more rigorous with the new MDR, so have the demands for MDR translations of relevant documents. Previously, technical documents that required CE marking in the past did not need translations pre-approval. Under the MDR, however, documents that receive CE markings, like instructions for use (IFUs) and patient information documents, must be translated into all 24 required languages to gain regulatory compliance. Accurate translation that is “clear and precise” is necessary across all official languages and is essential in ensuring that it is understood entirely and effectively regardless of who is reading the material. In addition, the EUDAMED database that all medical data is uploaded must be translated across the 24 official languages so it can be exchanged with all relevant stakeholders.
With all these new changes, medical device manufacturers need to establish a partnership with a language service provider (LSP) that is certified in ISO 13485:2016, ISO 17100: 2015, and ISO 9001: 2015 and has an in-depth understanding of the new EU MDR to ensure there are no delays for medical device products entering EU’s market. Combining our vast network of in-country professional linguists and subject matter experts, advanced language technology, and localization best practices, CSOFT enables EU market access for medical device companies across all 24 required languages.
Implantable Medical Device Translations
As the demand for medical devices increases, implantable medical device translations become essential for medical professionals, suppliers, and manufacturers. In addition, ensuring regulatory submission compliance is crucial to ensure these devices can be accessed globally. With a global team of in-country linguists and regulatory specialists, CSOFT Health Sciences can help assure regulatory submission compliance while providing exceptional translation and localization solutions across 250+ languages, helping implantable medical device companies gain foreign market access with reliance.
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Multilingual eLearning & Training Content
For global medical device companies, ensuring that staff is properly trained and updated with the new MDR compliance standards means effective translation of eLearning and training content is crucial for improving workflow and maintaining a quality management system (QMS). With proper training, employees could avoid missing vital data for documents submitted to the EMA, wasting time, money, and effort.
With a network of over 10,000 in-country professional linguists and subject matter experts, CSOFT provides highly accurate eLearning translation solutions across 250 languages. We have the expertise and resources to ensure that, regardless of the location of the manufacturing facility, we provide highly accurate translated eLearning materials for medical device employees and manufacturers to effectively understand the MDR requirements and mitigate any potential issues in the product development process.
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CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least 7 years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage translation memory and terminology management in real time through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001 and are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.