Overview of Language Requirements for Medical Devices in Each Member State under the EU MDR and IVDR Published by the European Commission

On 17th January 2024, the European Commission released two tables summarising the language requirements for manufacturers of medical devices under the EU MDR and IVDR. These tables consolidate the national translation requirements for medical devices and in vitro diagnostic medical devices, respectively, across 31 European countries. In this article, we analyse the key aspects of this publication, its benefits and limitations, and provide insights for manufacturers aiming for compliance.
EU Commission Language Requirements for Medical Devices in Europe

Boosting the Visibility of Your International Life Science Website: A Comprehensive Guide to Multilingual SEO Translation and Localisation

In the fast-paced world of digital marketing, multilingual search engine optimisation (SEO) has become a crucial weapon in the arsenal of successful marketing strategies for life science companies looking to expand their global reach. In today’s fiercely competitive digital environment, the translation of your life science website’s content serves as a potent catalyst to improve your online visibility, helping you better connect with your international audience. In this article, we explore the intricacies of multilingual SEO translation and localisation with a dedicated focus on the life sciences industry. From understanding the basics of SEO to the complexities of a multilingual...
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FAQs: Language Translation Requirements for Medical Device Companies Operating in the EU under the New EU MDR and IVDR

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In the rapidly evolving landscape of medical devices, patient safety takes precedence. When issues that could potentially pose risks to users and patients arise with a medical device, manufacturers must take swift corrective action. One essential tool in this process is the Field Safety Notice, a communication mechanism used by manufacturers to inform users and customers about safety concerns regarding their products. In this article, we explore the concept of Field Safety Notices, and discuss the mandatory language requirements applicable to them under the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR). What are...
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What Are the Language Requirements for Medical Device Registration in Latin America (LatAm)?

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Is Your Food Supplement Compliant with Food Advertising and Labelling of Food Supplements Rules?

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What Are the Language Requirements for Medical Devices in Turkey?

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