In May 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced to and fully covered by the Medical Device Regulation (MDR). The MDR brings many new changes, and with it challenges, to medical device manufacturers attempting to gain market access in EU’s diverse market. Under the MDR, some changes medical device companies will see is the formation of the European Databank on Medical Devices (EUDAMED) for greater responsibility of postmarket 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 establishing 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 will no longer be “grandfathering in” or “legacy” devices that have been on the market; all current devices will need to be redefined under the new MDR. With the transition period ending in 2025, it’s important for medical device companies and manufacturers to understand the changes of requirements for current devices in EU’s market, as well as future medical device products to not only save time, 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 has the demands for translations of relevant documents. Previously, technical documents that require CE marking in the past did not require 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 regardless of who is reading the material, it is understood entirely and effectively. In addition, the EUDAMED database that all medical data is uploaded to, must be translated across the 24 official languages so it can be exchanged with all relevant stakeholders.
With all these new changes, it’s important for medical device manufacturers to establish a partnership with a language service provider (LSP) that is certified in ISO 13485:2016 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.
Content Management Through Advanced Language Technology
To establish market share in the European Union, many kinds of technical documentation is needed for regulatory approval to ensure the safety and efficacy of the medical device product. In addition, for ensuring postmarket surveillance, maintenance of safety materials like postmarket clinical follow-up evaluation reports are crucial in protecting patients globally.
CSOFT understands the importance of managing, maintaining, and translating the large volume of documents medical device manufacturers are required to produce and submit to the EU. That is why we utilize our human translators and subject matter experts alongside our advanced machine translation technology. In addition to machine translation, we also have a cloud-based globalization management system to allow for unrivaled translation performance, helping multinational organizations and companies accelerate their global objectives with simpler, faster, and more cost-effective translation solutions.
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Multilingual eLearning & Training Content
For global medical device companies, ensuring that staff is properly trained and up to date with the new MDR compliance standards means effective translation of eLearning and training content is crucial for improving workflow as well as maintaining a quality management system (QMS). Without proper training, employees could be at risk for missing crucial data needed for documents being submitted to the EMA, resulting in wasted 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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We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
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Accurate and high-quality translations for medical device companies seeking EU market access is extremely important; inaccurate translation along the way can not only result in wasted time, money, and effort, but also negatively affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality medical device translation solutions for the life science industry. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through linguistic validation, back translation, terminology management, and in-country review (ICR) . We have the tools and team to help you meet the submission demands of the EMA under the implementation of the MDR.
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