IVDR question

[Barbara Depreter]

Will there be exceptions allowed to deviate from (upcoming) IVDR alternatives, without the need for changing your assay into a LDT (i.e. dilution of antibodies)?

[Pieter Vermeersch]

There is currently no official guidance on this point.

The European Commission has published a guidance document in May 2022 for changes to IVD tests by IVD producers:
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-6.pdf

The draft version of the guidance document for lab-developed tests that will most likely be published in fall 2022 refers to this document for significant/non-significant change.

[Pieter Vermeersch]

The European commission published a guidance document on significant/non-significant modifications of IVD tests for IVD manufacturers:
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

The European draft version of the guidance document on lab-developed tests that is expected fall 2022 refers to this document for significant/non-significant change. This includes information on the use of a different analyzer or modification to the method (e.g. use of a different wash bufffer is a non-significant change).

It remains to be determined if FAGG-AFMPS will require laboratories to validate and/or register such modifications.

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