The healthcare translation services market is witnessing noteworthy upsurge due to the rapid growth in the healthcare sector globally. With this growth trajectory at hand, we see notable growth in non-native speakers, and the critical need for accurate medical communication. Having said that, there are always looming challenges including maintaining confidentiality and security of sensitive information, ensuring cultural competency and the high costs of professional translation services.
This is where Lingo Chaps Translation Services, an India-based language service provider, specializes in devising high-quality Translation, Localization, Interpretation, Voice- Over, Subtitling, Transcription, and Transcreation Services not only in all major global and Indian languages, but also in rare languages. The company is spearheaded by Naveen Kar who brings more than two and a half decades of experience in the translation industry.
In an exclusive interview with India Pharma Outlook, Naveen delves into the must know nitty gritty of EU Medical Device Regulation (MDR):
Illuminate us with EU MDR and why it is important for the Medical Devices Industry.
The EU Medical Device Regulation (MDR) which was adopted on April 5, 2017, and entered into force on May 25, 2017. However, its full application was delayed until May 26, 2021, governs the production and distribution of medical devices in the European Economic Area. The main focus of the development was to drive higher safety and efficacy standards for these devices. Furthermore, the MDR imposes stricter requirements than the previous Medical Devices Directive (MDD), thereby enhancing transparency through the Unique Device Identification (UDI) system, traceability, clinical evaluations, and post-market surveillance.
What impact has the Introduction of the EU MDR had on Medical Device Translation Requirements?
Since the EU MDR came into effect, ensuring compliance in the translations of medical device documentation has never been more crucial than today. The regulation has mandated that all accompanying documentation which includes Product Description, Intended use / purpose, labels, instructions for use, and safety notices must be available in the official languages of the countries where the device is being marketed. This is explicitly required under MDR and IVDR to ensure that healthcare professionals, regulators, and patients have access to clear and understandable information. Additionally, this ensures that healthcare professionals, regulators, and patients will be able to access clear and accurate information in their native language.
Translation accuracy under the EU MDR is critical; any errors or ambiguity can lead to regulatory violations, product recalls, and even patient harm. You can count on our 24x7 services that are without costly markups of larger agencies with lifetime guarantee of accuracyNaveen Kar, Founder
What challenges do companies face in ensuring compliance with the EU MDR from a translation perspective?
Ensuring compliance with the EU MDR from a translation standpoint presents some pressing challenges that need to be dealt with. The MDR also calls for maintaining the integrity of technical and safety information across translations, which is critical for compliance and safety. Additionally, the complexity of medical terminology demands expert handling to ensure consistency and precision, particularly when it concerns safety-critical information. Furthermore, companies also face pressure to meet product launch deadlines which is coupled with the need of maintaining the accuracy of highly technical content.
How important is accuracy in translation when it comes to regulatory documents under the EU MDR?
When we talk about EU MDR regulatory documents, translation accuracy is absolutely critical. One should be aware that errors or ambiguities in translation can lead to regulatory violations, product recalls, lawsuits, and potential harm to patients. Hence, to prevent this, accurate translations ensure that all stakeholders, including healthcare providers and patients, have a clear understanding of how to properly use medical devices, ultimately contributing to improved health outcomes.
Could you share some best practices for companies looking to align their translation processes with the EU MDR requirements?*
To meet EU MDR requirements, selecting a translation provider with expertise in medical device regulations is imperative. Hence, partnering with certified agencies skilled in life sciences transcreation will ensure accurate, high-quality translations. Implement SOPs to track and verify translator credentials. By partnering with us directly, you receive expert medical translations at a more competitive price, avoiding large agency markups.
How crucial is the role of the translation industry in ensuring that these materials meet both regulatory and linguistic accuracy across different markets?
Today, the translation industry plays a crucial role in ensuring the regulatory and linguistic clarity of documentation and labeling under EU MDR 745 & 746. Therefore, accurate translations are of utmost importance for compliance with local regulations and provide healthcare providers and patients with the necessary information to use medical devices effectively. And with this situation at hand, the translation agency must work closely with medical device manufacturers to ensure that all the materials are not only linguistically accurate but also meet the stringent demands of these regulations. With this in place, a close collaboration will help eliminate miscommunication and prevent potential legal issues across varied markets.
Besides translation of documentation covered under EU MDR, how can you help the manufacturers of Medical Devices from India in expanding their market reach?
We help companies in translating their marketing material, brochures, agreements, certificates of compliance etc. We can also help companies develop and maintain micro websites wherein they can provide information in the language specific to the market country. It is also advised to translate Implant Cards, Summary of Safety & Clinical Performance (SSCP) / Summary of Safety & Performance (SSP) as the case may be.
For companies seeking various services, we can be a one-stop solution provider because of our links with associate partners involved in the field of Documentation preparation, Guidance on Implementation of systems and providing certifications.
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