Godfrey Town Ph.D.
The market for home-use devices (HUDs) available to consumers is expanding rapidly, with numerous indications (cleansing, anti-aging, hair removal, hair regrowth, acne, psoriasis etc.) available for purchase at major pharmacy retailers, department stores, spas and online. Lasers and intense light sources (ILS) are subject to standards and regulatory controls because of the unique potential hazard they pose to tissues of the eye and skin.
This talk reviews relevant recent safety standards including particular requirements for consumer laser products and the progress of the new EC Medical Device Regulations (MDR) which comprise requirements related to the safety and performance of medical devices and which replace the current Directive (93/42/EEC). Due for full implementation by May 2020, the MDR captures both medical devices and appliances without a medical purpose emitting high intensity electromagnetic radiation in the wavelength range 180-3000 nm intended for use on humans, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and ILS equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. This definition includes all HUDs.
There are currently insufficient Notified Bodies for medical devices in the EU and too few have so far applied for a new designation to be available when the EU Medical Devices Regulation becomes effective. This will cause a of bottleneck in Notified Bodies to test HUDs. This talk therefore considers the likely impact on laser and ILS manufacturers and distributors and probable impact on marketing of home-use light-based devices to the general public.