Welche Sprachen werden nach den sprachlichen Anforderungen der EU MDR in den einzelnen EU-Mitgliedstaaten akzeptiert?
7 June, 2022
![Sprachlichen Anforderungen der EU MDR](data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIyNTYwIiBoZWlnaHQ9IjE2MDAiIHZpZXdCb3g9IjAgMCAyNTYwIDE2MDAiPjxyZWN0IHdpZHRoPSIxMDAlIiBoZWlnaHQ9IjEwMCUiIHN0eWxlPSJmaWxsOiNjZmQ0ZGI7ZmlsbC1vcGFjaXR5OiAwLjE7Ii8+PC9zdmc+)
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.
Which Languages Are Accepted under the EU MDR Language Requirements for Medical Devices in Each EU Member State?
5 October, 2021
![MDR language requirements](data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSI1MDAwIiBoZWlnaHQ9IjMzMzMiIHZpZXdCb3g9IjAgMCA1MDAwIDMzMzMiPjxyZWN0IHdpZHRoPSIxMDAlIiBoZWlnaHQ9IjEwMCUiIHN0eWxlPSJmaWxsOiNjZmQ0ZGI7ZmlsbC1vcGFjaXR5OiAwLjE7Ii8+PC9zdmc+)
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](data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIyNTYwIiBoZWlnaHQ9IjE3MDciIHZpZXdCb3g9IjAgMCAyNTYwIDE3MDciPjxyZWN0IHdpZHRoPSIxMDAlIiBoZWlnaHQ9IjEwMCUiIHN0eWxlPSJmaWxsOiNjZmQ0ZGI7ZmlsbC1vcGFjaXR5OiAwLjE7Ii8+PC9zdmc+)
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.