Welche Sprachen für die EU-Konformitätserklärung sind gemäß EU-MDR/IVDR bei Medizinprodukten erforderlich?
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
09 Nov 2022
What Is the EU MDR/IVDR Language Requirement for the Declaration of Conformity for Medical Devices?
13 Oct 2022
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 Language Requirements in the EEA-EFTA Countries of Iceland, Liechtenstein, and Norway?
24 Aug 2022
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.
What Are the EU MDR/IVDR IFU Translation Requirements for Manufacturers of Medical Devices?
01 Jul 2022
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...Read more
Welche Sprachen werden nach den sprachlichen Anforderungen der EU MDR in den einzelnen EU-Mitgliedstaaten akzeptiert?
07 Jun 2022
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
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 Mar 2022
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 Feb 2022
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 Jan 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...Read more
Which Languages Are Accepted under the EU MDR Language Requirements for Medical Devices in Each EU Member State?
05 Oct 2021
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.