MDR - Medical Device Regulation

MDR - Medical Device Regulation (EU) 2017/745

Our medical wigs are certified Class I Medical Devices, fully compliant with European Regulation MDR (EU) 2017/745 (superseding Directive 93/42/EEC) and registered in the official EUDAMED database.

To ensure maximum safety and comfort, our products undergo rigorous clinical evaluation tests and biocompatibility testing according to international EN ISO 10993-1 standards, guaranteeing the use of tested, hypoallergenic, and skin-safe materials throughout the manufacturing process.