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.