As May 26th, 2020 approaches, most medical device companies understand the implementation dates associated with EU MDR 2017/745 and have a loose plan to come into compliance. While many organizations have decided to take the “wait and see” approach before making their content available in all 24 official languages of the EU Member States, forward-thinking organizations are getting it done now. Why?
Many translation agencies have been pressing medical device companies to act sooner rather than later over the last year. And as much as it may seem like fear mongering, the reality is that if too many organizations wait until the last minute to come into compliance, there won’t be enough qualified linguists to handle the rush. There, quite frankly, is a limited number of qualified linguists that exist in the world for each therapeutic area.
To compound this issue, the pool of talent across different language combinations varies. Some of the more commercial combinations like English into FIGS (French, Italian, German, Spanish) may have enough linguists to handle the influx of translation requests. However, less commercial language combinations will not. A good LSP will let you know up-front that they simply don’t have the resources to fill your translation request. Unfortunately, not all language service providers will do this. Instead, they will opt to cut out the editor or attach unqualified linguists to your project. This could lead to a series of revisions that can be both lengthy and costly.
Established Translation Memory may help alleviate the above issues, but not in every case. If you’re unsure about the impact your Translation Memory will have on the documents you need to have translated in order to come into compliance, now is a great time to start that discussion with your translation agency.
If your company’s fiscal year follows the calendar year, you are either discussing budgets for next year, or will be in the near future. If EU MDR isn’t part of the conversation, it should be.
As it relates to language translation, below are some of the areas of the new MDR that are worthy of your attention:
- You must have the required documents available in ALL 24 official languages of the EU Member States
- The scope of medical regulated devices have been expanded to include products with non-medical purposes (we’re looking at you, colored contact lenses)
- The required number of documents to be translated has been expanded. This list now includes documentation from the manufacturer, clinical trial and test documentation, patient and healthcare professional information, just to name a few.
- Updates to your existing technical documentation may be required to match the new MDR Requirements
- Translation will now be required prior to CE marking. Labels and Instructions for Use (IFUs) will need to be included in your technical dossier and submitted to a notified body; effectively moving translation up in a traditional workflow.
Alleviate any anxiety about MDR 2017/745 by entrusting EC Innovations with your translation projects. Take comfort in a provider that proudly holds the following certifications:
ISO 9001 and 17100 certifications; a testament to our dedication to provide you with accurate translations with a proven, managed translation process.
ISO 13485 certification. We understand the medical device world and care about buttoning up your supply chain.
ISO 27001 certification. We understand the importance of privacy and are dedicated to keeping all information assets secure.
HIPAA and GDPR Compliance: Confidential information, personally identifiable information (PII), and personal health information (PHI) are all secure when working with EC Innovations by way of advanced encryption methods and required fingerprint scanning for physical access to our secure servers.
Our full-time, professional linguists are handpicked, vetted, and are experts in a wide variety of therapeutic areas. Our Quality Management Team works closely with our Project Managers to ensure that all of our projects are in full compliance with the regulatory demands of the EMA (European Medicines Agency), the FDA (Food and Drug Administration), National Medical Products Administration (NMPA) and other national authorities worldwide. When your project is completed, EC Innovations will deliver your project with a certificate of accuracy, which is backed by a comprehensive, world-class business insurance policy.
Whether you need a six-hundred page technical manual or a segment of handwritten medical correspondence translated , EC Innovations has you covered. If you’re interested in more information about this topic or our translation services, you can visit our website at:
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For the latest information about the EU MDR, please visit the official website of the European Union at: