Hi Anon
As you suggest, for transition from IVDD to IVDR of clinical performance data that has been performed prior to the IVDR publication ('legacy' data), then a Manufacturer has to see how this fits into requirements under IVDR Annex XIII (with a gap analysis).
Under Annex XII section l.2.3. it states that clinical performance data needs to come from one of three sources:
'Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources:
- Clinical performance studies
- Scientific peer-reviewed literature
- Published experience gained by routine diagnostic testing
Clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data.'
i.e. If your 'legacy' studies do not comply with the IVDR requirements for 'Clinical Performance Studies' (first bullet) and then requirements referenced under Annex XIII 2.3, then the study/ies are 'other sources of clinical performance data' (mentioned below the three bullets under sec 1.2.3). It is possible to justify legacy studies as 'Clinical Performance Studies' (first bullet) and link to Annex XIII sec 2.3 if they have been performed appropriately.
If you cannot justify your studies as 'Clinical Performance Studies' then in order to comply with Annex XIII 1.2.3 you will need to demonstrate clinical performance of the device by either: scientific peer-reviewed literature (of your device), and/or published experience gained by routine diagnostic testing.
It's important to remember the point under Annex XIII 1.2.3 that states 'clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data'.
You are right then in making the link to PMS. The conclusion of your PER (ref Annex XIII 1.3.2) should then highlight if there are any gaps of the clinical evidence and performances demonstrated against state of the art (link to PE Plan and Scientific Validity). This would then follow whether post-market performance follow-up is needed, or justified at this time as to not.
I hope this helps.
Please reach out directly if you need further support - econway@mcra.com
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Erica Conway
Vice President, IVD Regulatory Affairs - Europe
MCRA, UK
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Original Message:
Sent: 16-Sep-2022 00:40
From: Anonymous Member
Subject: Clinical Evidence - IVDR
This message was posted by a user wishing to remain anonymous
Hello Community
I wanted to vet a potential approach to demonstrate clinical evidence for a Legacy IVD applying for IVDR certification.
The device has been on the market for a number of years CE marked as a list b device under the IVDD.
When performing the gap analysis to the IVDR i have ascertained that the performance evaluation studies conducted for IVDD CE marking, although robust and high in standard, do not meet the requirements of a clinical performance study under the IVDR, particularly in the documentation requirements. I do not feel however, that a full clinical performance study shall need to be repeated. As such i am considering the following approach for the documenting the clinical performance under the IVDR:
- make use the IVDD performance study but as 'published experience gained' (is that ok, considering this was a pre-market study?)
- Also make use of PMS, incident data etc as experienced gained
- Perform a PMPF study on the device to plug the gaps in data
What do you guys think of this approach?
Thanks