This is audio from RQM+ Live! #56, recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for upcoming sessions in the Knowledge Center at our website.

RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates.

In this session we will discuss:

Our three featured panelists are:

Questions:

3:10 -- How did you end up working in the diagnostics sector and what is your role at the notified body?

21:36 -- With only seven notified bodies designated so far, capacity issues seem to be ongoing. Do you see changes coming?

32:01 -- Let's talk about the application process in more detail... we're finding many manufacturers are struggling with this process - can you tell us some of the main issues notified bodies are seeing?

42:18 -- How can we be compliant as much as we can if the notified bodies don't know how to be compliant?

44:44 -- Let's talk about conformity assessment: once the manufacturer completes their application, what are the next steps and how long will it take before the file gets reviewed and they can expect a certificate?

50:25 -- How are you dealing with virtual manufacturers?

59:28 -- For Class D devices, we are not aware that any IVDR certificates have been issues yet for high risk devices. When can we expect the first one to be issued?

1:02:19 -- Do you have any final recommendations for our audience as they prepare for IVDR?