The clinical evaluation of medical devices under the MDR is not based on a standard, but on various MDCG guidance documents and MEDDEV 2.7/1 rev. 4. In the past, this led to differing requirements from notified bodies and uncertainty on the manufacturers’ side. ISO 18969 Clinical evaluation of medical devices is intended to change this.
It has now reached the public consultation phase. This will be followed by the processing of the comments. Publication is expected at the end of next year at the earliest.
A key point in the standard will be the more direct link to risk management. The new standard is also intended to set decision criteria for the proportionality of clinical data 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.
Follow the progress up to publication at ISO/DIS 18969 – Clinical evaluation of medical devices