European Medical Devices Regulation delayed until 2021 due to Covid-19
The European Medical Devices Regulation, which was due to come into force on May 26, 2020, has been postponed by one year due to the coronavirus pandemic.
Many aesthetic devices will then be classified as medical, meaning manufacturers will have to partner with a designated “notified body” to obtain a CE Mark; and implement a quality-management system for production, in line with the EN ISO 13485:2016 standard. There are also other, more detailed, requirements.
The MHRA told Professional Beauty that while the European Commission has not yet confirmed which specific products will be included within each category, machines based on technologies such as radiofrequency, microcurrent and LED may be covered by the category outlined in Annex XVI of the regulations, which also includes laser and IPL.
There is no requirement for clinics or salons to ensure that existing devices in use are compliant. As the new enforcement date falls outside of the UK’s transition period to leave the EU, the MHRA said it will provide more guidance in due course.