{"id":272551,"date":"2024-09-12T10:37:14","date_gmt":"2024-09-12T08:37:14","guid":{"rendered":"https:\/\/www.matachana.com\/?p=272551"},"modified":"2024-09-12T10:38:30","modified_gmt":"2024-09-12T08:38:30","slug":"since-may-2024-matachana-has-been-mdr-certified-for-its-wide-range-of-steam-and-low-temperature-sterilizers","status":"publish","type":"post","link":"https:\/\/www.matachana.com\/en\/since-may-2024-matachana-has-been-mdr-certified-for-its-wide-range-of-steam-and-low-temperature-sterilizers\/","title":{"rendered":"SINCE MAY 2024 MATACHANA HAS BEEN MDR-CERTIFIED FOR ITS WIDE RANGE OF STEAM AND LOW TEMPERATURE STERILIZERS"},"content":{"rendered":"<p><BR><\/BR><br \/>\nThe MDR 2017\/745 (Medical Devices Regulation) is the European law that replaces the current MDD 93\/42\/EC (Medical Devices Directive) and introduces significant changes to current legislation. These changes have several clear purposes:<\/p>\n<ul>1.<b> Improve documentation and clinical studies: <\/b>The MDR requires more comprehensive and rigorous documentation for Medical Devices (MD). The importance of clinical studies to support the safety and efficacy of devices is also emphasised.<\/ul>\n<ul>2.<b> Post-Market Surveillance (PMS): <\/b>The MDR establishes a more rigorous monitoring system once the devices are on the market. This allows the early detection of problems and a more effective response to protect patients and users.<\/ul>\n<ul>3.<b> Improved traceability: <\/b>Both the manufacturers and authorities of member countries must guarantee solid traceability of MD. The public unique identification system (UDI code) makes this task easier.<\/ul>\n<p>In short, the MDR seeks to increase patient and user safety through closer monitoring of devices throughout their lifetime.<\/p>\n<p>Antonio Matachana, S.A. is one of the leading companies in our sector in obtaining the MDR certification for all its sterilizers since May this year. This achievement was possible after a complex and demanding audit process carried out by our Notified Body, the T\u00dcV Rheinland (0197), which lasted for several months.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The MDR 2017\/745 (Medical Devices Regulation) is the European law that replaces the current MDD 93\/42\/EC (Medical Devices Directive) and introduces significant changes to current legislation. These changes have several clear purposes: 1. Improve documentation and clinical studies: The MDR requires more comprehensive and rigorous documentation for Medical Devices (MD). The importance of clinical studies [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":272510,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false},"categories":[204,4],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MATACHANA - HAS BEEN MDR-CERTIFIED<\/title>\n<meta name=\"description\" content=\"SINCE MAY 2024 MATACHANA HAS BEEN MDR-CERTIFIED FOR ITS WIDE RANGE OF STEAM AND LOW TEMPERATURE STERILIZERS\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.matachana.com\/en\/since-may-2024-matachana-has-been-mdr-certified-for-its-wide-range-of-steam-and-low-temperature-sterilizers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MATACHANA - 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