Regulatory Open Forum

I'm working on Technical Documentation for transitioning a Class A non-sterile cytometer from IVDD to IVDR. The instrument itself does not generate any diagnostic result, it is intended for use with IVD reagents to identify lymphocyte subsets. The instrument is Class A non-sterile, therefore is over due for IVDR compliance. The reagent is Class C and still has about 3 years of transition time. I'm reusing all the previous IVDD data trying to get through IVDR without any additional testing.
I've found on some consulting companies' website indicating that clinical performance study is not expected for Class A product, therefore clinical performance study report (CPSR) is not required. But I don't see this kind of statement in any MDCG or other guidelines. Would you please let me know if this is true?
Thank you very much!

Good day Anon,

It will not be specifically stated a Class A, non-sterile classed device does not require a Clinical Performance Study or associated report.  That determine needs to be made by the organisation within the context of the Performance Evaluation, Annex XIII.  If reading through Annex XIII there is no clear distinction which devices or class of devices would require performance evaluation or not.  All IVD medical devices require performance evaluation, but the activities within performance evaluation are determined, justified, and rationale generated for why components of performance evaluation would not be required.  As an example specifically from Section 1.2.3 it states: 'Demonstration of the clinical performance The manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable.'  Emphasised and you will find similar wording throughout the Annex.  There is also additional guidance in MDCG 2022-2 as example where scientific validity for Class A devices does not need to be done if can be justified.

The answer being all IVD medical devices require performance evaluation.  It is up to the manufacturer to define, defend, and provide sufficient clinical evidence why the IVD medical device would not require further clinical evidence and/or clinical data to support the devices safety and performance.  Again, going back to Annex XIII there is wording about the scientific validity, analytical performance, and clinical performance which requires each or a combination of each.  Therefore, it is up to the Manufacturer to define and justify whether clinical performance study would be required or not.

I'm working on Technical Documentation for transitioning a Class A non-sterile cytometer from IVDD to IVDR. The instrument itself does not generate any diagnostic result, it is intended for use with IVD reagents to identify lymphocyte subsets. The instrument is Class A non-sterile, therefore is over due for IVDR compliance. The reagent is Class C and still has about 3 years of transition time. I'm reusing all the previous IVDD data trying to get through IVDR without any additional testing.
I've found on some consulting companies' website indicating that clinical performance study is not expected for Class A product, therefore clinical performance study report (CPSR) is not required. But I don't see this kind of statement in any MDCG or other guidelines. Would you please let me know if this is true?
Thank you very much!