{"id":20155,"date":"2023-11-20T14:54:57","date_gmt":"2023-11-20T13:54:57","guid":{"rendered":"https:\/\/www.laffineur.com\/eu-member-states-and-european-commission-adopt-a-medical-device-software-hardware-combinations-guidance\/"},"modified":"2023-11-20T14:55:04","modified_gmt":"2023-11-20T13:55:04","slug":"eu-member-states-and-european-commission-adopt-a-medical-device-software-hardware-combinations-guidance","status":"publish","type":"post","link":"https:\/\/www.laffineur.com\/en\/eu-member-states-and-european-commission-adopt-a-medical-device-software-hardware-combinations-guidance\/","title":{"rendered":"EU Member States and European Commission adopt a Medical Device Software Hardware combinations Guidance"},"content":{"rendered":"<p style=\"text-align: justify;\">On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-10\/md_mdcg_2023-4_software_en.pdf\">Medical Device Software (MDSW) Hardware combinations Guidance<\/a>. This Guidance is aimed at helping manufacturers of medical software understand how to make products in conformity with the applicable regulatory requirements when combining MDSW with hardware or hardware components. This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are tackled in other guidance.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a Medical Device Software (MDSW) Hardware combinations Guidance. This Guidance is aimed at helping manufacturers of medical software understand how to make products in conformity with [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[151],"tags":[],"class_list":["post-20155","post","type-post","status-publish","format-standard","hentry","category-european-law"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EU Member States and European Commission adopt a Medical Device Software Hardware combinations Guidance - Laffineur - Cabinet d&#039;avocats<\/title>\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.laffineur.com\/en\/eu-member-states-and-european-commission-adopt-a-medical-device-software-hardware-combinations-guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Member States and European Commission adopt a Medical Device Software Hardware combinations Guidance - Laffineur - Cabinet d&#039;avocats\" \/>\n<meta property=\"og:description\" content=\"On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a Medical Device Software (MDSW) Hardware combinations Guidance. 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