The draft of the forthcoming international standard on the clinical evaluation of medical devices has been published on the ISO website. This starts the public commenting phase.
ISO/DIS 18969 describes how clinical evaluations are to be carried out systematically across the entire product lifecycle. It specifies, for example, which sources of evidence may be used.
Until the standard is finally adopted, clinical evaluation under the existing MDR requirements and the current guidance, in particular MEDDEV 2.7/1 Revision 4, remains the gold standard. Manufacturers should therefore continue to follow these requirements, but can already use the draft to prepare for the future harmonisation.
Find out about the current status at ISO/DIS 18969 – Clinical evaluation of medical devices