The Perfect Label—Complying with the MDR

完美的标签-符合MDR

2021-02-18 12:25 United Language Group

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European Medical Device Regulation (MDR) is continuously evolving, making it difficult to keep up with all of its requirements. It is important to understand these guidelines to ensure that your medical devices meet the required standards. Functions of MDR Labeling In the second part of a three-part webinar series, Ronald Boumans, Senior Consultant for of Regulatory Affairs for Emergo by UL and an expert on MDR labels, discussed the importance of labeling. Proper labels are crucial in order for a device be properly identified under the MDR. The label has five basic functions: Identifies the physical product Identifies the purpose of the product Identifies the manufacturer of the product Identifies the product type Identifies instructions and product warnings EUDAMED and Language Access The label enables the manufacturer to speak directly to the person who will use the product. Because the label is a crucial point of communication, it is essential that all text be translated properly. With 24 languages in the E.U., we know how complex your label can get! Symbols, on the other hand, are universal for all 24 official European languages, scoring a big win for your medical device label. Symbols include CE number, expiration date, LOT number, serial number, etc. It’s crucial that the label clearly identify the product manufacturer. This is necessary in case customers need to contact the manufacturer with questions or concerns. It is not necessary, however, to include a phone number on the label. Products come in all shapes and sizes, and sometimes, it can be tricky to determine how to place a label. Not to worry! If a product is having a hard time fitting a label, the label can be split up into multiple parts. Labels for MDR can be tedious and difficult to understand. For a deeper dive into MDR labeling, request a recording of "The Perfect Label." hbspt.cta._relativeUrls=true;hbspt.cta.load(3356907, 'ffe21457-7b73-4df6-84e2-69ec6fa983b8', {}); Life Science Language Solutions At United Language Group we pride ourselves in being industry experts, so you don’t need to take the time to bring us up to speed on regulations, industry-specific guidelines, and the strictest global requirements. We understand scientific language and processes as well as the intricacies of settings in which your translations may be used. Let’s connect.
欧洲医疗器械法规(MDR)不断发展,难以跟上其所有要求。了解这些指南以确保您的医疗设备符合所要求的标准是很重要的。 MDR标记的功能 在由三部分组成的网络研讨会系列的第二部分中,Ronald Boumans,UL Emergo监管事务高级顾问和MDR标签专家,讨论了标签的重要性。为了在MDR下正确识别设备,正确的标签是至关重要的。标签有五个基本功能: 标识物理产品 标识产品的用途 标识产品的制造商 标识产品类型 标识说明和产品警告 EUDAMED和语言访问 该标签使制造商能够直接与将要使用该产品的人交谈。因为标签是沟通的一个关键点,所以正确翻译所有文本是至关重要的。欧盟有24种语言,我们知道你的标签有多复杂!另一方面,所有24种欧洲官方语言的符号都是通用的,这为您的医疗设备标签赢得了巨大的胜利。符号包括CE号,到期日,批号,序列号等。 标签上清楚地标明产品制造商是至关重要的。这是必要的情况下,客户需要联系制造商的问题或关切。但是,没有必要在标签上包括电话号码。产品有各种形状和大小,有时,确定如何放置标签是很棘手的。不用担心!如果一个产品有一个困难的时间适合标签,标签可以被拆分成多个部分。 MDR的标签可能是乏味和难以理解的。为了更深入地了解MDR标签,请录制“完美标签”。 hbspt.cta._relativeURLS=true;hbspt.cta.load(3356907,'FFE21457-7B73-4DF6-84E2-69EC6FA983B8',{}); 生命科学语言解决方案 在联合语言集团,我们为自己是行业专家而自豪,因此您不需要花时间来使我们了解法规,特定行业的指导方针和最严格的全球要求。我们理解科学语言和过程,以及你的翻译可能被使用的复杂环境。我们连线吧。

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