How a Professional Translation Service Handles Medical Device Regulations

Medical Business Translation Services Tackling New Medical Device Rules: (EU) 2017/745 & (EU) 2017/746

Professional Translation Service Handles Medical Device RegulationsOverregulation can often collide with growth and business goals in the medical device industry. This is why medical business translation services are key to tackling the red tape often coming with strict new device regulations in the European Union and beyond.

An experienced professional translation service concentrating on the translation and localization requirements of new medical devices can help a firm beat out its slower-moving competition, while reducing some of the bureaucratic and economic pain new regulations can cause.

Smaller Medical Device Companies Ramping Up Research

According to a recent survey by Emergo (a consultancy focusing on medical device regulatory issues), medical device firms (more than 50% of those surveyed overall, and 61% of smaller companies) are set to ramp up R&D efforts for new devices over the next year or so.

Of course more devices crossing more international borders for medical trials — and eventual sales —  means an increase in the need for a professional translation service to handle medical term translation, clinical recruitment documents, instruction manuals, software translations and all of the regularity paperwork needed to successfully enter a national or regional (European) market as quickly as time — and red tape — will allow.

Global Medical Device Competition

With Asian, European and North American firms of varying sizes all vying for a piece of the medical device industry pie, it’s important to recognize what motivates companies to invest in research, as well as invest in medical and pharmaceutical translation services.

The Emergo survey, which looked at over 500 firms around the world, found that R&D is on everyone’s mind. Smaller companies tended to focus on finding a niche, and then developing and launching new medical technology for that niche. Larger and midsize companies are investing in research “to stay ahead of competition” and “update dated or obsolete technologies.” And while their business strategies vary some, small, large and midsize medical device firms could all likely benefit if they took advantage of business translation services focused on the international medical field — and all of the regulatory hurdles found within.

Issues Surrounding New European Medical Device Regulations

New European medical device regulations (MDR) passed in April, 2017, could be set to dampen down the enthusiasm of some device manufactures working on or marketing products in Europe.

Regulations (EU) 2017/745 and (EU) 2017/746 will gradually kick in over the next 3 to 5 years. These regulations focus on establishing stronger pre-market scrutiny tools, tightening the rules surrounding clinical investigation requirements, developing a more robust device tracking system, and reinforcing post-market surveillance requirements for device manufacturers. The stated driving force behind these new regulations is dealing with fraud, while improving fair trade, as well as health and safety standards for EU citizens.

While more stringent regulations could prove beneficial for patients and consumers, some European manufacturers are contemplating suspending the sales of some current devices, and removing others from the European market completely. The fear is they won’t meet the new regulations. Companies also don’t want to wait in line to establish compliance with the new rules.

Crossing an obstacle course is much easier done with a trained horse that has been around the course a few times! When it comes to overcoming the newest regulatory obligations, seeking the advice of a professional translation service will save you time, money and a lot of hassle. Business translation services that are ISO certified, specializing in the business of medical term translation — and also providing medical and pharmaceutical translation services — can help your firm navigate some of the trickier aspects of regulatory and translation requirements found in Europe (and around the planet), while honing your competitive edge and protecting your brand, at the same time.


Medical TranslationRead our whitepaper 5 Case Studies in Medical Translations, a 10 minute read that will help you understand some of the challenges involved and how to overcome them! You can also register to attend the 15 minute free healthcare Translation webinar.

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