Medical Device GUI (Graphical User Interface) Translation for the EU: A Guide for Manufacturers Making Software Available to European Users
24 June, 2024 Medical Device GUI Translation The popularity of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) is rapidly rising, with an estimated one in four medical devices now relying on software. For manufacturers aiming to penetrate the European Union (EU) market, translating the graphical user interface (GUI) of their medical device software is essential for ensuring regulatory compliance as well as user engagement across the diverse linguistic landscape of Europe. Building on our previous discussion on the EU MDR language requirements for GUIs, this article explores the practical aspects of translating GUIs of software applications made available to users across...
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FAQs: Language Translation Requirements for Medical Device Companies Operating in the EU under the New EU MDR and IVDR
19 October, 2023 medical device translation requirements in Europe Are you a medical device company preparing to place your products on the European market? The new European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) introduce language translation requirements that might leave you bewildered, especially if you are new to the EU market. Navigating the intricacies of these new regulations and finding definitive answers to your questions, often very specific to your unique circumstances, can quickly become a challenging and time-consuming task for you and your regulatory team. The absence of clear guidance can lead to frustrating searches, yielding ambiguous results open to interpretation.
What Are the MDR and IVDR Language Requirements for Field Safety Notices for Medical Devices?
29 August, 2023 MDR Field Safety Notice Language Requirements 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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Is Your Food Supplement Compliant with Food Advertising and Labelling of Food Supplements Rules?
30 May, 2023 Food supplement advertising rules In today’s health-conscious society, the popularity of food supplements has soared. To protect consumers, preserve brand reputation, and avoid legal pitfalls, manufacturers and marketers must comply with labelling and promotional regulations. Getting your copy right from the start is also vital, to prevent misleading information being reproduced in translation. In this article, you will learn how to ensure regulatory compliance for your product information and its promotional material.
What Are the EU MDR Language Requirements for Medical Devices in Montenegro And How Can We Ensure Compliance?
31 March, 2023 Language Requirements for Devices in Montenegro Montenegro’s progress towards full membership of the European Union has led to the harmonisation of many of its laws with EU legislation, including medical device legislation. The marketing of medical devices is subject to particularly stringent regulatory measures in the EU market, which has recently seen the introduction of new mandatory language requirements for product information, such as labels and instructions for use. This article aims to provide insights into the language requirements for medical devices in Montenegro and their implications for medical device companies intending to enter the Montenegrin market.
What Are the Language Requirements for Medical Devices in Serbia?
8 March, 2023 Language requirements for medical devices in Serbia Serbia is making significant progress towards membership of the European Union and, as part of this process, has harmonised a number of its laws and regulations with EU legislation. One such legal area concerns the marketing of medical devices. This is subject to stringent regulatory measures, including mandatory language requirements for the product information accompanying the medical device, such as the label and instructions for use. As a result, manufacturers of medical devices intending to place their products on the Serbian market must follow strict language rules. This article will explore the language requirements for medical devices in Serbia and...
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What Are the Language Requirements for Medical Devices in Turkey?
13 February, 2023 MDR Language Requirements in Turkey Nearly 80% of medical devices in Turkey are imported, with as many as half of those imports coming from the European region. While still a candidate for EU membership, Turkey has developed a strong trading relationship with the EU spanning nearly three decades, in order to facilitate the movement of medical technologies into its market. This relationship relies heavily on the alignment of Turkish medical device legislation with that of the EU. The scope of this harmonisation also covers the language requirements for medical devices in Turkey. In this article, we discuss the linguistic rules for manufacturers and importers of...
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What Are the Language Requirements for Devices in Switzerland?
19 January, 2023 Language Requirements for Devices in Switzerland Like many other European countries, Switzerland strongly relies on imports to meet a growing demand for innovative medical devices. In order to facilitate international trade, the country has aligned its medical devices legislation with the EU MDR and the EU IVDR. This harmonisation also covers language requirements for information supplied with medical devices placed on the trilingual Swiss market. In this article, we discuss key provisions for the mandatory language requirements for devices in Switzerland, and what they mean for manufacturers and importers.
Dans quelles langues faut-il traduire la déclaration de conformité UE pour les dispositifs médicaux mis sur le marché de l’UE ?
9 December, 2022 déclaration de conformité UE En qualité de fabricant, avant la mise sur le marché européen de votre dispositif médical, vous devez d’abord démontrer que votre produit est conforme à la législation européenne en vigueur. La déclaration de conformité UE est un document incontournable de ce processus réglementaire. Selon l’État membre où votre dispositif médical sera mis à disposition, la déclaration de conformité devra être traduite dans la ou les langues officielles du pays en question. Dans cet article, nous examinons les exigences linguistiques imposées dans les textes réglementaires s’appliquant aux dispositifs médicaux (DM) et aux dispositifs médicaux de diagnostic in vitro (DMDIV) s’agissant de la...
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Quelles sont les langues acceptées dans le cadre des exigences linguistiques du RDM dans chaque État membre de l’UE ?
2 December, 2022 exigences linguistiques du RDM Le nouveau règlement européen relatif aux dispositifs médicaux (RDM) resserre les contraintes entourant la commercialisation des dispositifs médicaux sur le marché européen. Il exige en effet que chaque État membre de l’Union européenne définisse la ou les langues dans lesquelles un dispositif est mis à disposition. Dans cet article, nous présentons les langues acceptées dans chaque État membre conformément aux exigences linguistiques du RDM.
What Are the EU IVDR Language Requirements for Screens and Software?
25 November, 2022 IVDR Language Requirements for Screens and Software The value of in vitro diagnostic medical devices resides in the quality of diagnostic data they provide. The EU IVDR 2017/746 states very clearly that an in vitro diagnostic medical device must be supplied with information in an official EU language(s) chosen by the Member State in which it is made available to the user or patient. However, it is less clear whether these translation rules also apply to text appearing on the device’s screen and in software that is a device in itself. In this article, we revisit the linguistic provisions under the IVDR, and focus specifically on the...
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Welche Sprachen für die EU-Konformitätserklärung sind gemäß EU-MDR/IVDR bei Medizinprodukten erforderlich?
9 November, 2022 Sprachen für die EU-Konformitätserklärung Bevor Sie ein Medizinprodukt in der EU in den Verkehr bringen können, müssen Sie als Hersteller zunächst nachweisen, dass Ihr Produkt der geltenden EU-Gesetzgebung entspricht. Die EU-Konformitätserklärung ist dabei ein zentrales Dokument. Je nach EU-Mitgliedstaat, in dem Sie Ihr Medizinprodukt einführen möchten, muss Ihre EU-Konformitätserklärung möglicherweise in die Amtssprache(n) des jeweiligen Landes übersetzt werden. In diesem Artikel möchten wir Sie über die Anforderungen an die Sprachen für die EU-Konformitätserklärung informieren, die von den Verordnungen für Medizinprodukte und In-vitro-Diagnostika der EU (MDR und IVDR) gestellt werden. Ganz konkret gehen wir auch auf die Sprachen ein, die in den einzelnen EU-Mitgliedstaaten akzeptiert...
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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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