Dear members, following on from the good news that ISO TC 210 WG had reconfirmed ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, meaning that it remains unchanged until April 2030, two other updates have been received.
The guidance on the implementation of ISO 13485 will be updated and released as ISO TS 23485 in 2026
The draft (FDIS) of ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice, is imminent. The updates in this version include risk management and adverse event categorization. This standard is applicable to Medical Devices, but could impact studies involving both IVDs and Medical devices.
ISO 20196:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice, remains the IVD specific guidance on clinical performance studies, and was reconfirmed earlier in 2025, so should remain as is until 2030, when it’ due it’s next periodic review.
