What Are the Language Requirements for Medical Devices Sold in Europe under the New EU Medical Devices Regulation?
19 July, 2021
Following a transition period of four years, the long-awaited Medical Device Regulation (MDR) 2017/745/EU finally became fully applicable on 26 May 2021. It makes provisions in several places that the information provided by the manufacturer with a medical device must be available in the official language(s) accepted in the Member State where it is being sold. In this article, we will discuss the MDR language requirements for medical devices placed on the EU market.
Following a transition period of four years, the long-awaited Medical Device Regulation (MDR) 2017/745/EU finally became fully applicable on 26 May 2021. It makes provisions in several places that the information provided by the manufacturer with a medical device must be available in the official language(s) accepted in the Member State where it is being sold. In this article, we will discuss the MDR language requirements for medical devices placed on the EU market.
Are you a medical device company attracted by the prospect of overseas opportunities? You have developed a fantastic product and chosen a top distributor for your target market. Your export journey has got off to a great start. Now, with its new export strategy, your company is moving into unchartered waters. Part of this strategy is content localisation and you want to understand more about it to make the right strategic decisions for your target export market. In this article you will learn what content localisation is, and why getting it right is essential for the optimal performance and safety...
Getting ready to export? Overwhelmed with advice and information on the cultural adaptation of your written content? Perhaps you have some questions already, such as how to prepare your written content for translation, or whether your user-facing content translation really needs to be adapted to your target foreign market. In this article, you will learn what user-facing content is, and how to prepare it for the markets you are planning to enter.
Czy dokumentację medyczną powinien tłumaczyć wyłącznie tłumacz medyczny? Jakie kwalifikacje posiada tłumacz medyczny? Czy sama znajomość języka obcego nie wystarczy? Na te i podobne pytania odpowiemy w tym artykule.
Your hard work has paid off. Your breakthrough medical technology idea is off the ground, and you are now planning to share information about it in another language. Whether you are developing your first prototype, or gearing up to take your innovation to the market, getting your content translated may at first seem like yet another obstacle on your journey to the end-user. But done right, your medical device translation project can accelerate your success. So, how can you prepare your content for translation to ensure the best possible outcome, as well as the most efficient use of your budget?
Whether it’s to take advantage of the latest specialist treatment options, to enjoy a better quality of care, or due to personal circumstances, more and more people receive medical treatment in another country. Cross-border medical travel often requires a medical record translation service. Regardless of your circumstances, your medical documentation has to be translated swiftly and absolutely accurately.
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