Finished IVD’s are exempt from Biocides regulation however intermediates and raw materials are not exempt. PT 2 and 3 are regarding disinfectants, and PT 6 is regarding preservatives used in products. PT 2 & 3 can have an indirect impact on IVD’s by impacting the available disinfectants available for use to disinfect IVD’s. Companies placing products on the market which…
Ben KempJanuary 16, 2025