The revision includes clarifications for borderline cases, including red blood cell additive solutions containing adenine, dual action creams with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers, and mobile sterile air systems. Other examples remain unchanged.
What does this mean for you?
Manufacturers and regulatory teams can use the updated manual to confirm the correct qualification and classification of their products, supporting compliance decisions and avoiding potential regulatory disputes.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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