Welche Sprachen für die EU-Konformitätserklärung sind gemäß EU-MDR/IVDR bei Medizinprodukten erforderlich?
9 November, 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
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
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.
Although the MDR and the IVDR are medical device regulations of the EU, their application extends beyond the EU to other European Economic Area countries which enjoy access to the European single market. In this article, we discuss the EU MDR/IVDR language requirements in the EEA-EFTA countries of Iceland, Liechtenstein, and Norway.
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...
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.
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.
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.
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.
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...
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.
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?