Update manual on borderline classification IVDR and MDR published

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.