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16TH IMDRF meeting in Yekaterinburg, Russia – meeting documents available

Posted on 04.11.2019

The last meeting of the IMDRF took place in Yekaterinburg in Russia on 16-18 September and the outcome statement of the IMDRF management committee (MC) as well as the presentations delivered during the stakeholders’ meeting are now available on the IMDRF website.

As the outcome statement describes, the MC discussed progress regarding several work items, including the proposed draft N60 “Principles and Practices for Medical Device Cybersecurity”, which has recently been released for public consultation (until 2 December).

In addition, the MC approved three final documents from the Medical Device Clinical Evaluation Working Group: N55: Clinical Evidence – Key Definitions and Concepts, N56: Clinical Evaluation, and N57: Clinical Investigation, therefore, they expect to be published soon.  As for the new work item proposals, the MC accepted to work on updating the document on Post-Market Clinical Follow-Up Studies (GHTF/SG5/N4).

See the outcome statement for more information.