Reportable changes to IVDs: Implementation of REACH Regulation

We have been informed that, as part of the implementation of the REACH Regulation, certain chemical substances used in the manufacturing of IVDs may be restricted or phased out. This may lead to the replacement or removal of certain components, for example, detergents such as Triton X‑100 or NP‑40, borates, formaldehyde-based preservatives, and nonylphenol or octylphenol ethoxylates (NPEs/OPEs), etc., which are commonly used as lysis or enzymatic buffers, washing solutions, stabilizers or fixatives agents.

We kindly remind you that any change in formulation, substitution, or removal of components in the reagents potentially impacting the performance of prequalified IVDs constitutes a reportable change. Such changes must be submitted for assessment by filling a WHO IVD Reportable Change Form available here.