What Is the EU MDR/IVDR Language Requirement for the Declaration of Conformity for Medical Devices?
13 October, 2022 language requirement for the declaration of conformity Before placing your medical device on the EU market, as the manufacturer you must first demonstrate that your product complies with the applicable EU legislation. The EU declaration of conformity is an essential document in this regulatory process. Depending on the EU Member State where your medical device will be made available, the EU declaration of conformity may also need translating into the country’s national language(s). In this article, we will discuss the EU MDR/IVDR language requirement for the declaration of conformity. You will also learn which language versions of it individual EU Member States accept.
What Are the EU MDR/IVDR IFU Translation Requirements for Manufacturers of Medical Devices?
1 July, 2022 MDRIVDR IFU translation requirements The EU MDR/IVDR IFU translation requirements are among the many measures aimed at ensuring patient safety and protecting public health within the new EU regulatory framework for medical devices. The linguistic diversity of the EU Member States, however, poses a challenge for manufacturers of medical devices planning to place their product on the EU market. In this article, we focus specifically on instructions for use, commonly referred to as the IFU. Read on to find practical information on how the language aspects of your IFU are regulated by the EU MDR and the EU IVDR, including the language version(s) you...
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Welche Sprachen werden nach den sprachlichen Anforderungen der EU MDR in den einzelnen EU-Mitgliedstaaten akzeptiert?
7 June, 2022 Sprachlichen Anforderungen der EU MDR Bei Medizinprodukten, die in der EU verkauft werden sollen, sind nach der neuen Medizinprodukteverordnung (MDR) der EU strengere sprachliche Anforderungen einzuhalten. Zudem liegt es nun auch in der Verantwortung der einzelnen EU-Mitgliedstaaten festzulegen, in welchen Sprachen die Produktinformationen jeweils bereitgestellt werden müssen. In diesem Artikel zeigen wir Ihnen, welche Sprachen in den einzelnen EU-Mitgliedstaaten gemäß den sprachlichen Anforderungen der EU MDR akzeptiert sind.
What Are the EU IVDR Language Requirements for In Vitro Diagnostic (IVD) Medical Devices and Which Languages Are Accepted in Each EU Country?
19 May, 2022 IVDR Language Requirements On 26th May 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 became applicable across all 27 EU Member States, marking the start of a five-year progressive roll-out for in vitro diagnostic medical devices on the EU market. Among its various changes to the EU regulatory framework are the IVDR language requirements. In this article, we will discuss what these IVDR language requirements are, and which local languages individual EU Member States accept in response to them.
Pro Bono Ukrainian Medical Translation: Helping Patients from Ukraine with Their Medical Documentation
14 March, 2022 Ukrainian Medical Translation It is impossible to even fathom the sheer scale of the current humanitarian crisis unfolding in Europe, but the stories of individual patients fleeing the horrors of the war tell us how much they urgently need a Ukrainian medical translation service. At Mastermind Translations, we are helping patients from Ukraine with their medical documentation while also supporting our Ukrainian medical linguists. Find out how you can help, too.
What’s in the Latest Version of EMA’s Veterinary Product Information Template?
18 February, 2022 EMA QRD veterinary product information template version 9.0 The European Medicines Agency has updated its veterinary product information template to support the implementation of the new Veterinary Medicinal Products Regulation which became applicable on 28th January 2022. In this article, we discuss what changes have been made, what triggered them, and what they mean for applicants and marketing authorisation holders of veterinary medicinal products.
What Are Our Predictions for the Life Science Translation Industry in 2022?
21 January, 2022 Life Science Industry Predictions 2022 As 2022 begins, it’s time for life science organisations to start executing plans for the year ahead. Whether you’re entering a new export market or launching a new product in a country where you already have a presence, translation of your written content will be part of the all-important specifics, from regulatory paperwork to package labelling or marketing literature. How will the new trends in the life science translation industry affect your plans for the coming year? Will you pay less for your translation and have it done faster over the next 12 months? Read on for our insights into...
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Which Languages Are Accepted under the EU MDR Language Requirements for Medical Devices in Each EU Member State?
5 October, 2021 MDR language requirements The new European Union Medical Device Regulation has introduced more stringent linguistic requirements for medical devices sold in the EU market. In doing so, it has placed the responsibility on each EU Member State to determine the official Union language(s) in which the information supplied with the device must be provided. In this article, we will outline which languages are accepted in individual 27 EU Member States in response to these MDR language requirements.
What Are the Language Requirements for Medical Devices Sold in Europe under the New EU Medical Devices Regulation?
19 July, 2021 MDR Language Requirements for Medical Devices in the EU 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.
Why Content Localisation is Key to the Optimal Performance and Safety of Your Medical Device
18 June, 2021 Technical document localisation 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...
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How to Optimise User-Facing Content Translation for Your New Export Markets
27 May, 2021 User-facing content translation 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.
How to Prepare Your Document for a Medical Device Translation Project
24 February, 2021 Medical Device Translation 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?
How Professional Medical Record Translation Can Help You Get the Treatment You Need
29 January, 2021 Medical Records Translation 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.