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EU MDR Changes and Language Translation

The implementation of the European Union Medical Device Regulation (EU MDR) is well underway. Consisting of complex and sweeping changes, the new regulations, guidelines and enforcements are more stringent than its predecessor, the Medical Devices Directive (MDD). Released in 2017, medical device manufacturers were given a three-year transitionary period – with the new regulation taking effect May 26, 2020.

Even if you’re headquartered outside of the EU, you will need to comply if you export medical devices or products to any EU country. Given that U.S. medical device manufacturers account for nearly 70% of imports to EU nations, there’s a good chance your business will be affected.

Stay on Top of Translation Requirement Changes

If your products previously were outside of the MDD mandates, they may now fall under the purview of the MDR. According to the EU MDR, the definition of medical devices is: “any instrument, apparatus, appliance software, implant, reagent, material or other article intended by the manufacturer to be used alone or in combination, for human beings.” Medical devices such as dental and surgical instruments, bandages, splints, and hospital beds fall under the EU MDR. This definition is further broadened to include non-prescription contact lenses, derma fillers like Botox, skin resurfacing lasers, and equipment used for cosmetic procedures such as liposuction. The range is far reaching with nearly everything considered medical, as well as products for cleaning, sterilizing and disinfecting under the regulation’s guidelines.

While language translation played a part in the MDD, the MDR is tasked to increase translation accuracy and details for device labeling, packaging, use instructions, product information, documentation and anything else associated with medical devices/products. A search of the word ‘documentation’ within the EU MDR reveals more than 200 references to the term. This undertaking takes on more complexity by the 24 official EU languages, which medical device manufacturer’s will need to provide appropriate translations for.

Previously, each of the EU’s member states were responsible for confirming what needed to be translated and into which languages. As outlined by the Medical Device Coordination Group in the MDCG 2018-2 (nomenclature of EUDAMED), the “availability of names and descriptions in all official EU languages is recognized as being of high importance.” Furthermore, it will be the responsibility of the medical device/product manufacturer to ensure translations are in the national language of the country the medical devices/products are exported to. While there are many facets to the new regulations, language translation will play a pivotal role in compliance.

Don’t Struggle with Language Translation Alone

Unless you have a team of language translators that are proficient in all 24 official EU languages, chances are you will need to partner with a language service provider. By complying with the EU MDR, you’ll be able to improve medical device market share and gain competitive advantages. To do this efficiently and effectively, you need an established language service provider that has a proven medical translation background.

For more than 20 years BURG Translations has provided medical translation services to medical device manufacturing companies. The complexity and rigorous requirements of this field requires a team of linguistic translators that are more than conventional translators, they need to be specialists with experience. Our quest for quality doesn’t end with our experienced and specialized translators, technology or proven workflow processes – we also hold ISO certifications in all the right areas.

To consistently deliver the translation quality we’ve built our reputation on, BURG Translations maintains strict adherence to the ISO 9001:2015 (quality management system requirements) and ISO 17100:2015 (translation industry quality standard). Our years of certification have given us a quality control system that is not only a proven success, but one our clients can consistently rely on.

With a history that spans more than eight decades, BURG Translations has the unparalleled expertise to reliably deliver quality translations. You get the peace of mind of knowing your EU MDR translations are done right the first time.

Forward Translation Examples

Cambios en el MDR de la Unión Europea y traducción de idiomas

La implementación del Reglamento de dispositivos médicos (Medical Device Regulation, MDR) de la Unión Europea está muy avanzada. Los reglamentos, las pautas y los mecanismos de cumplimiento presentan cambios complejos y radicales, y son más estrictos que los de su predecesora, la Directiva de dispositivos médicos (Medical Devices Directive, MDD).

Se implementó en 2017, por lo que los fabricantes de dispositivos médicos tuvieron un período de transición de tres años; el nuevo reglamento entrará en vigencia el 26 de mayo de 2020.

Incluso si tiene sus oficinas fuera de la UE, deberá cumplir con este reglamento si exporta dispositivos o productos médicos a cualquier país de la UE. Dado que los fabricantes de dispositivos médicos de EE. UU. representan casi el 70 % de las importaciones a las naciones de la UE, hay posibilidades ciertas de que su empresa se vea afectada.

Manténgase al tanto de los cambios en los requisitos de traducción

Si anteriormente sus productos no se regían por la MDD, es posible que ahora se encuentren en el ámbito del MDR. Según el MDR de la UE, la definición de dispositivos médicos es “cualquier instrumento, aparato, software de dispositivo, implante, reactivo, material u otro artículo destinado por el fabricante para su uso en seres humanos, solo o en combinación”.

Los dispositivos médicos, como los instrumentos dentales y quirúrgicos, los vendajes, las férulas y las camas de hospital, están incluidos en el MDR de la UE. Esta definición se amplía aún más para incluir lentes de contacto sin receta, rellenos dérmicos como bótox, láseres para rejuvenecimiento de la piel y equipos utilizados para procedimientos cosméticos como la liposucción. La gama es de amplio alcance e incluye casi todo lo que se considera dentro del ámbito de la medicina, así como productos de limpieza, esterilización y desinfección, según las pautas del reglamento.

Si bien la traducción de idiomas desempeñó un papel importante en la MDD, el MDR tiene la tarea de aumentar la precisión de la traducción y los detalles para el etiquetado del dispositivo, el embalaje, las instrucciones de uso, la información del producto, la documentación y cualquier otro elemento asociado con los dispositivos/productos médicos. Una búsqueda de la palabra “documentación” en el MDR de la UE revela más de 200 referencias al término. Esta tarea adquiere más complejidad por los 24 idiomas oficiales de la UE, que deberán contar con sus respectivas traducciones suministradas por el fabricante de dispositivos médicos.

Anteriormente, cada uno de los estados miembros de la UE era responsable de confirmar qué era necesario traducir y a qué idiomas. Según lo detallado por el Grupo de coordinación de dispositivos médicos (Medical Device Coordination Group, MDCG) en el MDCG 2018-2 (nomenclatura de EUDAMED), “se reconoce que es muy importante contar con la disponibilidad de nombres y descripciones en todos los idiomas oficiales de la UE”. Además, será responsabilidad del fabricante del dispositivo/producto médico garantizar que las traducciones estén en el idioma nacional del país al que estos se exporten. Si bien hay muchas facetas en los nuevos reglamentos, la traducción de idiomas desempeñará un papel fundamental en su cumplimiento.

No luche solo con la traducción de idiomas

A menos que tenga un equipo de traductores que dominen los 24 idiomas oficiales de la UE, es probable que necesite asociarse con un proveedor de servicios de idiomas. Si cumple con el MDR de la UE, podrá mejorar su participación en el mercado de dispositivos médicos y obtener ventajas competitivas. Para hacer esto de manera eficiente y eficaz, necesita un proveedor de servicios de idiomas establecido que tenga experiencia comprobada en traducción médica.

Durante más de 20 años, BURG Translations ha brindado servicios de traducción médica a compañías que fabrican dispositivos médicos. La complejidad y los requisitos rigurosos de esta especialidad requieren un equipo de traductores lingüísticos que sean más que traductores convencionales; deben ser especialistas con experiencia. Nuestra búsqueda de calidad no termina con nuestros traductores experimentados y especializados, nuestra tecnología o nuestros procesos de flujo de trabajo comprobados; también contamos con certificaciones ISO en todas las áreas pertinentes.

Para ofrecer constantemente la calidad de traducción en la que se basa nuestra reputación, BURG Translations cumple estrictamente con las normas ISO 9001:2015 (requisitos del sistema de gestión de calidad) e ISO 17100:2015 (estándar de calidad de la industria de la traducción). Nuestros años de certificación nos han provisto de un sistema de control de calidad que no solo es un éxito comprobado, sino un sistema en el que nuestros clientes siempre pueden confiar.

Con una trayectoria que recorre más de ocho décadas, BURG Translations tiene una experiencia sin igual que le permite entregar traducciones fidedignas y de calidad. Tendrá la tranquilidad de saber que sus traducciones se realizarán correctamente conforme al MDR de la UE desde un principio.

Back Translation Examples

Changes in the European Union MDR and Language Translation

The implementation of the  European Union Medical Device Regulation (MDR)  is very advanced. These regulations, guidelines, and compliance mechanisms present complex and radical changes, and are more strict than those of its predecessor the Medical Devices Directive (MDD). It was implemented in 2017 and, as a result of which, medical device manufacturers had a three-year transition period; the new regulation will go into effect on May 26, 2020.

Including if they have their offices outside of the EU, they will have to comply with this regulation if they export medical devices or products to any EU country. Since US medical device manufacturers represent almost 70% of imports to EU nations, there is a strong possibility that your company will be affected.

Stay Up to Date on Changes in Translation Requirements

If your products were not previously regulated by the MDD, it is possible that you are now within the scope of the MDR.  According to the EU MDR, the definition of a medical device is “any instrument, apparatus, device software, implant, reagent, material, or other item intended by the manufacturer for its use in human beings, alone or in combination.” Medical devices, like dental and surgical instruments, bandages, splints, and hospital beds, are included in the EU MDR. This definition is being broadened even more to include non-prescription contact lens, dermal fillers like Botox, lasers for skin rejuvenation, and equipment used for cosmetic procedures like liposuction. The range is far-reaching and includes almost all of what is considered within the scope of medicine as well as cleaning, sterilization, and disinfection products, according to the regulation’s guidelines.

Even though language translation played an important role in the MDD, the MDR has the task of increasing the precision of the translation and details for the device label, packaging, instructions for use, product information, documentation, and any other item associated with medical devices/products. A search for the word “documentation” in the EU MDR reveals more than 200 references to the term. This task acquires more complexity due to the EU’s 24 official languages, which will have to have their respective translations supplied by the medical device manufacturer.

Previously, each of the EU member states was responsible for confirming what was necessary to translate and in which languages. According to what is detailed by the Medical Device Coordination Group (MDCG) in MDCG 2018-2 (EUDAMED nomenclature), “it is recognized that it is very important to have the availability of names and descriptions in all of the EU’s official languages.” In addition, it will be the responsibility of the manufacturer of the medical device/product to guarantee that the translations are in the national language of the country to which they are being exported. Even though there are a lot of facets in the new regulations, language translation will play a fundamental role in their compliance.

Do not Struggle with Language Translation Alone

Unless you have a team of translators who are fluent in the 24 official languages of the EU, it is likely that you will need to work with a language service provider. If you comply with the EU MDR, you will be able to improve your participation in the medical device market and get a competitive advantage. In order to do this in an efficient and effective manner, you need an established language service provider who has proven experience in medical translation.

For more than 20 years, BURG Translations has provided medical translation services to medical device manufacturers. The complexity and rigorous requirements of this specialty require a team of linguistic translators who are more than conventional translators; they must be specialists with experience. Our search for quality does not end with our experienced and specialized translators, our technology, or our proven workflow processes; we also have ISO certifications in all of the pertinent areas.

In order to consistently offer the translation quality on which our reputation is based, BURG Translations strictly meets ISO 9001:2015 (quality management system requirements) and ISO 17100:2015 (translation industry quality standard) standards. Our years of certification have provided us with a quality control system that is not only proven, but a system that our clients can always trust.

Spanning more than eight decades, BURG Translations has unequaled experience that allows them to deliver reliable and quality translations. You will have peace of mind knowing that your translations will be done correctly in accordance with the EU MDR from the beginning.

We are Proud to be Associated & Certified By

 
TUV management service ISO 9001
TÜV Rheinland certified
european language industry association
american translators association
GALA - globalization & localization association
association of language companies