EU MDR Changes and Language Translation The Clock is Ticking – Will You be Ready?

With just a couple of weeks to go in 2019, the new year is approaching fast, and with it comes the implementation of the European Union Medical Device Regulation (EU MDR). 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.  

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5 assumptions you shouldn’t make about medical device translation

If you’ve worked in the medical device industry for any amount of time you know the importance of labeling. On each device, you must provide critical information for the patient, including usage instructions, warnings, and risks. With how important the labels are on your medical devices, it makes sense that you cannot afford to cut corners when it comes to translating the text for resale in other countries.

As a business, you want to save time and money whenever possible. However, cutting corners to finish a job quickly instead of accurately today could cost you quite a bit more over the long run.

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Reaching non-English speakers in the US

The number of non-English speakers in the United States continues to grow. According to the United States Census Bureau, there was a 158% growth of non-English speakers between 1980 and 2010. This number continues to rise year after year.

It begs the question: with over 20% of Americans speaking a language other than English in their home, how are you marketing to this large population?

Non-English speakers might understand some English. However, there is no denying that they respond better to communication in their native tongue. For marketers, this is an important consideration to make when planning campaigns.

If you are considering translation, here are a few ways non-English marketing materials can have a major impact on your company’s growth and sales.

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The future of the global medical device industry

If the data is any indicator, the global medical device industry is skyrocketing to huge growth in the next few years. According to the Global Medical Device Industry 2012-2017: Trend, Profit, and Forecast Analysis, the industry, which has grown significantly over the past five years, will hit $302 billion in the US by 2017. That’s fantastic news for those of you who work in the medical device field.

This industry, which includes cardiovascular, surgical, home health, and general medical devices, is still highly fragmented, with nearly half (46%) of the global market focused in the United States.

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How to market your medical device anywhere in the world

Marketing a product is a challenge in any field, but marketing medical products in other countries is riddled with even more obstacles. In addition to simply trying to provide a product that people find useful and want to buy, you also have the additional layers of culture and language to contend with.

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5 tips for smarter medical device labeling

If you’re in the medical device industry, you know the strict regulations that govern what you can put on your packaging. Think beyond the content on your product’s container and apply these tips to your instructions for use and marketing materials as well to ensure you comply with requirements both here in the US as well as any new markets you enter.

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