Update manual on borderline classification IVDR and MDR published
Update manual on borderline classification IVDR and MDR published
Regulatory Affairs Medical Devices In Vitro Diagnostics EU MDR EU IVDR
Tuesday, 30 September 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 12 September 2025 a new manual on borderline classification IVDR and MDR was published
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Update manual on borderline classification IVDR and MDR | QbD Group
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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.
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Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.
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