European Medical Device Regulation delayed until 2021
The European Medical Devices Regulation was supposed to come into force on 26 May this year, but enforcement has been postponed by one year due to the coronavirus pandemic.
Many aesthetic and cosmetic products will then be classified as medical devices, meaning manufacturers will have to partner with a designated Notified Body to obtain CE-Mark certification; and will be required to implement quality-management systems according to the EN ISO 13485:2016 standard.
However, there has been confusion over specifically which products and devices will be affected. Aesthetic Medicine contacted the MHRA (Medical Healthcare Regulatory Authority) for clarification and asked if machines based on technologies such as radiofrequency, microcurrent and LED would be included.
We were told that while The European Commission has not yet confirmed which products will be included within each category, these devices may be covered by the following category outlined in Annex XVI of the regulations: “High-intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.”
There is no requirement for clinics to ensure new or existing devices in use are compliant. As the new enforcement date falls after the UK’s transition period to leave the EU, the MHRA says it will provide more guidance in due course.
