In the regulatory area of medical devices, there have been constant changes and innovations since the implementation of the new MDR. The latest news concerns plans for a new standard for the clinical evaluation of medical devices. It is to bear the number ISO 18969.
According to insider information from the Association Française de Normalisation (AFNOR), the planned standard will define terminology, principles, and a procedure for the clinical evaluation of medical devices. The described procedure will serve to assess the risks of medical devices and clinical benefits. No details are known yet as it is still a work in progress. a&r will follow-up on the upcoming developments and keep you up to date.