{"id":18701,"date":"2021-08-04T09:22:08","date_gmt":"2021-08-04T07:22:08","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18701"},"modified":"2023-01-25T17:15:31","modified_gmt":"2023-01-25T16:15:31","slug":"standard-iso-20916-regulates-clinical-performance-studies-for-ivd-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/08\/04\/standard-iso-20916-regulates-clinical-performance-studies-for-ivd-devices\/","title":{"rendered":"STANDARD: ISO 20916 regulates clinical performance studies for IVD Devices"},"content":{"rendered":"\r\n

The ISO 20916:2019 standard<\/strong> \u201cIn vitro diagnostic medical devices \u2013 Clinical performance studies using specimens from human subjects \u2013 Good study practice\u201d provides detailed information on Clinical Performance Studies (CPS)<\/strong> for in vitro Diagnostic Medical Devices<\/strong>.<\/p>\r\n\r\n\r\n\r\n

\"ISO\r\n
ISO 20916 regulates clinical performance studies for IVD Devices<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n

What is the purpose of ISO 20916?<\/strong><\/h2>\r\n\r\n\r\n\r\n

Clinical performance <\/strong>studies for\u00a0in vitro Diagnostic Medical Devices<\/strong> are essential if analytical performance studies or methods such as literature research are not sufficient to assess the performance of the IVD device.<\/p>\r\n\r\n\r\n\r\n

For a long time there has been a lack of clear guidelines on the design and management of performance studies for IVD devices. This gap was filled in 2019 with ISO 20916:2019.<\/p>\r\n\r\n\r\n\r\n

ISO 20916<\/strong> is intended <\/strong>to define good study practices<\/strong> for the planning, design, conduct, registration and reporting of clinical performance studies<\/strong>.<\/p>\r\n\r\n\r\n\r\n

These clinical performance studies allow the safety of in vitro Diagnostic Medical Devices to be evaluated.<\/p>\r\n\r\n\r\n\r\n

Clinical Performance Studies for IVD Medical Devices<\/strong><\/h2>\r\n\r\n\r\n\r\n

Clinical performance measures the ability of an IVD Device to produce results related to a particular clinical condition or physiological\/pathological condition in accordance with its intended use.<\/p>\r\n\r\n\r\n\r\n

Clinical performance studies <\/strong>are undertaken to verify or confirm aspects of IVD Device<\/strong> performance that cannot be determined by analytical performance studies and by the pertinent literature. This information is then used to demonstrate compliance<\/strong> with the relevant general safety and performance requirements<\/strong>.<\/p>\r\n\r\n\r\n\r\n

Clinical performance studies should be conducted taking every precaution to protect the health and safety of the patient, taking into account all regulatory and ethical requirements<\/strong> and using sound scientific principles, such as:<\/p>\r\n\r\n\r\n\r\n