{"id":1692,"date":"2022-01-24T10:00:42","date_gmt":"2022-01-24T04:30:42","guid":{"rendered":"https:\/\/www.ulatus.com\/translation-blog\/?p=1692"},"modified":"2022-02-15T20:09:49","modified_gmt":"2022-02-15T14:39:49","slug":"how-localization-is-important-for-eu-mdr","status":"publish","type":"post","link":"https:\/\/www.ulatus.com\/translation-blog\/how-localization-is-important-for-eu-mdr\/","title":{"rendered":"How Localization is Important for EU MDR"},"content":{"rendered":"

How Localization is Important for EU MDR<\/strong><\/h2>\n

When healthcare companies develop new medical devices, they have to follow an extensive list of strict regulations before launching their product. In the European Union (EU), which has 500,000 medical devices on the market, medical device businesses face an updated set of stringent requirements called the EU Medical Device Regulation (MDR). Because these rules will have a global impact on any company that plans to introduce a medical device in the EU market, the localization of medical device documentation<\/a> will be a significant part of meeting the MDR protocols.<\/p>\n

What is the EU MDR?<\/strong><\/h2>\n

The EU MDR is a new set of mandates that regulates the manufacturing and distribution of medical devices across Europe, and compliance with the rules is compulsory for businesses that want to sell their medical devices there. As part of the EU MDR, medical device companies are accountable for their products for the entire lifecycle of the device. Additionally, the MDR increases requirements for device labels, including mandating that the labels are translated into the language of the country where the device will be marketed and sold.<\/p>\n

Furthermore, the requirements provide a means of ensuring that the medical device technical information is more understandable to patients. In addition, the regulations recognize software as a medical device, which was less evident in the EU\u2019s previous set of regulations, the Medical Devices Directive (MDD).<\/p>\n

Localization is Vital to Meeting the Requirements<\/strong><\/h2>\n

Because of the EU MDR, the translation and localization of medical device documentation are even more essential now than they were previously, especially since companies are responsible for attaining the translations, instead of depending on the EU member states to manage them.<\/p>\n

To meet the new requirements, the following localization steps are necessary:<\/p>\n