Discussions with IG-NB on issues relevant for device approval

Embedded in an initiative launched by OR.NET e.V., some members of the PoCSpec project are currently participating in a working group that is working on the clarification of approval-relevant issues in connection with networked systems. Following initial individual contacts with test centers and notified bodies, contact has now been established with the IG-NB (Software Working Group). The IG-NB is an association of notified bodies for medical devices, forming a community of interest. The aim of IG-NB is to develop common positions, to coordinate the interests of the German Notified Bodies and to better enforce them vis-à-vis industry and authorities. Currently, the IG-NB has ten Notified Bodies for medical devices as members. The IG-NB is organized by the Verband der TÜV e.V. (Vd TÜV) in terms of organization.

In the first joint meeting, the activities of OR.NET e.V. were presented with regard to openly networked medical devices, SDC Conformance Principles and the MOVE test platform. After the different information and positions were initially exchanged in the further meetings, the current discussion now focuses on the following questions:

  • How does one manage to generate trustworthy test tools?
  • How does the exchange of certificates work?
  • How does ensemble formation work?
  • How can the influence on risk management and usability be presented?
  • Where does the responsibility of the manufacturer or certification end?
  • Where does the responsibility of the operator begin?

In order to be able to offer manufacturers and test bodies a guide in the future, a guidance document is to be jointly developed. A first rough draft is available. This document is to be developed in smaller working groups and later published and maintained under the direction of OR.NET e.V..