Guidelines help determine the ultimate regulatory framework for conflicting products at the intersection of the MDR, IVDR, Cosmetics, Biocides, and the Medicinal Products Directive.
Dual Purpose Device
A group of devices that serve both medical and non-medical purposes (e.g., cosmetic), regulated under the MDR as both medical devices and Annex XVI products.
Annex-XVI-Products
A group of products solely intended for non-medical purposes (e.g., cosmetic)—not medical ones—yet still regulated under the EU Medical Device Regulation (MDR).
PMCF
PMCF stands for Post-Market Clinical Follow-Up. It involves targeted activities conducted to monitor the clinical safety and performance of a medical device after it becomes available on the market
