ISO 18969 on the Clinical Evaluation of medical devices in progress |

https://www.iso.org/standard/85514.html

Happy that an ISO standaard for the clinical evaluation of medical devices is progressing. Especially given there is no MDCG guidance available yet apart from the ones for orphan medical devices, equivalence, medical device software, and sufficient evidence for legacy devices. So we are still stuck with MEDDEV 2.7.1 and the IMDRF MDCE WG/N56 for proper guidance for new medical devices not being medical device software.