Lasers and intense light sources (ILS) – which include intense pulsed light (IPL) and light emitting diode (LED) technologies – are suitable for a range of interventions, from invasive surgical procedures, such as laser lipolysis and ablative skin rejuvenation, to non-invasive therapies, such as hair reduction, tattoo removal and non-ablative skin rejuvenation.
Lasers and ILS are subject to standards and regulatory controls because of the unique potential hazard they pose to tissues of the eye and skin, including the risk of blindness and skin burns.1,2
In the European Union (EU), including the UK, devices based upon optical energy have been used for both medical and cosmetic applications. The Care Quality Commission (CQC) defines the scope of medical or surgical procedures as treatments provided by a healthcare professional, which are related to disease, disorder or injury.3 This is reflected in the European Medical Device Regulation (MDR),4 which comprises requirements that relate to the safety and performance of medical devices.
This article describes the different standards and regulations for medical and cosmetic devices in the UK and explains what aesthetic practitioners need to know with regard to purchasing and training.
Any medical device placed on the EU market must comply with relevant legislation. Manufacturers' products which meet 'harmonised standards' have a presumption of conformity to the MDR (previously the…
