What Are the Language Requirements for Medical Device Registration in Latin America (LatAm)?
Latin America, with its vast population of over 650 million across 20 countries, presents a rapidly growing market for medical device companies. Factors such as population growth, enhanced healthcare accessibility, and an increase in chronic diseases have fuelled rising demand for medical technologies in the region. Recent improvements in the medical device regulatory framework further facilitate market entry for medtech companies with global ambitions. To successfully navigate the local regulatory environment, manufacturers must comply with language requirements, and ensure that specific information is provided in the requested languages, such as Spanish or Portuguese. In this article, we explore the language...Read more
23 Jul 2023
Is Your Food Supplement Compliant with Food Advertising and Labelling of Food Supplements Rules?
30 May 2023
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 Mar 2023
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?
08 Mar 2023
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...Read more
What Are the Language Requirements for Medical Devices in Turkey?
13 Feb 2023
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...Read more
What Are the Language Requirements for Devices in Switzerland?
19 Jan 2023
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 ?
09 Dec 2022
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...Read more
Quelles sont les langues acceptées dans le cadre des exigences linguistiques du RDM dans chaque État membre de l’UE ?
02 Dec 2022
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 Nov 2022
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...Read more
Welche Sprachen für die EU-Konformitätserklärung sind gemäß EU-MDR/IVDR bei Medizinprodukten erforderlich?
09 Nov 2022
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...Read more