Live! #59 – Clinical Evidence vs. Clinical Performance – A Deep Dive into MDCG 2022-2 and Notified Body Expectations

Device Advice by RQM+

This is audio from RQM+ Live! #59, recorded 21 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

MDCG 2022-2 was intended to provide guidance on how to demonstrate clinical evidence, however we continue to receive so many questions and requests for support around this topic. The concept that clinical evidence is not clinical performance can still be hard for manufacturers to get their heads around, especially considering the cost and effort it will take to demonstrate clinical evidence.

We discuss:

• Differences between clinical evidence and clinical performance, and where we see manufactures struggle
• Notified body expectations and what they will not allow to pass
• Steps to generating data that will be accepted by the notified bodies, and our lessons learned so far; and
• Challenges and guidance on generating clinical evidence for specific IVDs, like general use devices and instruments

Panelists:

• Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
• Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation
• Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
• Ron Sills – Senior Principal Specialist

Timestamps:
3:33 -- What exactly is clinical evidence under IVDR and how much of it is a jump compared to the IVD directive?

7:44 -- We're getting a lot of questions related to clinical evidence and it seems to be what everyone is talking about - why is this such a hot topic?

21:32 -- For CDx, if clinical trial with the US test site and EU collection site the device won't be used anywhere except the US, do we have to register with a competent authority?

22:33 -- If a method comparison should not be considered as a clinical performance study, can you define clinical performance study? What is expected in terms of sample sources and sites for a clinical performance study?

26:32 -- How should manufacturers demonstrate clinical performance under the IVDR?

32:58 -- Our experience with NB other data source is only supporting data but peer reviewed lit and routine diagnostic data can be used. [panelists discuss]

34:07 -- How many patient samples need to be tested for Class C IVD test for IVDR clinical performance?

35:26 -- Any comments related to the clinical performance and evidence monitoring, especially during electromagnetic capability testing under 60601.

36:45 -- Could you please expand a bit on EQI schemes?

39:30 -- How often do you have to update PMPF?

41:37 -- Problem: legacy device (class III, implantable) never implanted to date; start of registry (register) with CRO in 08/2022 but no clinical study running. [panelists discuss]

43:13 -- What would you say the highlights were in the MDCG clinical evidence guidance that was published in the beginning of the year for IVDs?

49:30 -- In order to establish clinical evidence for blood IVD assay, we are struggling to find a laboratory medicine standard on what accuracy is required for a specific analyte (e.g. cholesterol). Suggestions?

52:16 -- How does physically moving device production from one facility to another impact IVDR registration or existing 510(k)s.

53:07 -- Can we quantify benefits for IVD? We currently do a qualitative assessment.

54:45 -- What is required to demonstrate State of the Art for IVDs?