{"id":27726,"date":"2025-10-27T10:28:42","date_gmt":"2025-10-27T10:28:42","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&p=27726"},"modified":"2026-08-27T13:03:57","modified_gmt":"2026-08-27T13:03:57","slug":"draft-iso-18969-public-consultation","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/draft-iso-18969-public-consultation\/","title":{"rendered":"Draft of ISO 18969 in Public Consultation"},"content":{"rendered":"

The clinical evaluation of medical devices<\/strong> under the MDR is not based on a standard, but on various MDCG guidance documents<\/strong> and MEDDEV 2.7\/1 rev. 4<\/strong>. In the past, this led to differing requirements from notified bodies<\/strong> and uncertainty on the manufacturers’ side<\/strong>. ISO 18969 Clinical evaluation of medical devices is intended to change this.<\/p>\n

It has now reached the public consultation phase<\/strong>. This will be followed by the processing of the comments. Publication is expected at the end of next year at the earliest<\/strong>.<\/p>\n

A key point in the standard will be the more direct link to risk management<\/strong>. The new standard is also intended to set decision criteria for the proportionality of clinical data<\/strong> in demonstrating a positive benefit-risk ratio: the quantity, type and quality of clinical data should be proportionate to the risk, the complexity of the device and the clinical benefit<\/strong>.<\/p>\n

Follow the progress up to publication at ISO\/DIS 18969 – Clinical evaluation of medical devices<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27726","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"\nDraft of ISO 18969 in Public Consultation<\/title>\n<meta name=\"description\" content=\"ISO DIS 18969 enters public consultation to standardize MDR clinical evaluations and align data requirements with risk levels.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/news\/draft-iso-18969-public-consultation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Draft of ISO 18969 in Public Consultation\" \/>\n<meta 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