{"id":6398,"date":"2024-09-30T09:40:43","date_gmt":"2024-09-30T07:40:43","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6398"},"modified":"2024-10-02T09:28:13","modified_gmt":"2024-10-02T07:28:13","slug":"regular-workshop-on-the-regulation-of-medical-devices-compliance-check-before-making-medical-devices-available-on-the-market-2","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/regular-workshop-on-the-regulation-of-medical-devices-compliance-check-before-making-medical-devices-available-on-the-market-2\/","title":{"rendered":"Regular workshop on the regulation of medical devices: COMPLIANCE CHECK BEFORE MAKING MEDICAL DEVICES AVAILABLE ON THE MARKET"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p><strong>28th November 2024, Ljubljana<\/strong><\/p>\n\n\n\n<p><strong>Regular workshop on the regulation of medical devices: COMPLIANCE CHECK BEFORE MAKING MEDICAL DEVICES AVAILABLE ON THE MARKET (Slovenian language)<\/strong><\/p>\n\n\n\n<p>Our regular workshop is intended for everyone who wants to\nacquire basic knowledge or improve their competences in the field of checking\ncompliance with requirements before making medical devices (hereinafter\nreferred to as devices) available on the market, which is crucial for importers\nand distributors and represents an important requirement according to\nRegulation 2017 \/745\/EU on medical devices (MDR) and Regulation 2017\/746\/EU on\nin vitro diagnostic medical devices (IVDR), which is a necessary part of inspection\ncontrol.<\/p>\n\n\n\n<p>The knowledge acquired and the checklists you receive at the\nworkshop will ensure you:<\/p>\n\n\n\n<p>\u2713 optimal fulfillment of the compliance\ncheck obligation before enabling accessibility in accordance with the MDR and\nIVDR;<\/p>\n\n\n\n<p>\u2713 practical knowledge to check:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>equipment with a CE mark; <\/li><li>whether the manufacturer has prepared an EU\ndeclaration of conformity; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li><li>whether the manufacturer is known and has\nappointed an authorized representative; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li><li>information provided by the manufacturer; &nbsp;&nbsp;<\/li><li>data of the importer;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\n<\/li><li>whether the manufacturer has determined the UDI,\nand &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li><li>certificate;<\/li><\/ul>\n\n\n\n<p>\u2713 establishing an appropriate\nrepresentative sampling method to optimize the number of checks for the gadgets\nyou distribute;<\/p>\n\n\n\n<p>\u2713 adequate evidence of compliance with the requirements for checking before making the accessories accessible in the event of an inspection.<\/p>\n\n\n\n<p><strong>Click&nbsp;<a href=\"https:\/\/www.rapharm.eu\/wp-content\/uploads\/2024\/09\/241128-Informacije-Delavnica-preverjanje-pripomockov-1.pdf\">HERE<\/a> for more information on the workshop.<\/strong><\/p>\n\n\n\n<p><strong>Click&nbsp;<a rel=\"noreferrer noopener\" href=\"http:\/\/www.rapharm.eu\/en\/apply-for-education\/\" target=\"_blank\">HERE<\/a>&nbsp;to apply for&nbsp;the workshop.\ufeff<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>28th November 2024, Ljubljana Regular workshop on the regulation of medical devices: COMPLIANCE CHECK BEFORE MAKING MEDICAL DEVICES AVAILABLE ON THE MARKET (Slovenian language) Our regular workshop is intended for everyone who wants to acquire basic knowledge or improve their competences in the field of checking compliance with requirements before making medical devices (hereinafter referred&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[],"class_list":["post-6398","post","type-post","status-publish","format-standard","hentry","category-current-educations-and-trainings"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regular workshop on the regulation of 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