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aestheticmed.co.uk INDUSTRY NEWS

Medical device regulation delayed until 2021

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

83% of doctors not tested
for covid-19

A survey conducted by The Royal College of Surgeons of
Edinburgh (RCSEd) and The Doctors’ Association UK found
that at the time it was released at the beginning of May, 83%
of doctors surveyed hadn’t yet been tested for coronavirus.
The survey had 378 respondents from foundation year
doctors to consultants, working at 151 different NHS Health
Trusts and Boards across the UK. 81% said their Trust or
Board was only testing staff displaying symptoms, while
68% said they had colleagues who had displayed symptoms
but only 10% had gone on to be tested themselves.
Professor Michael Griffin OBE, president of the RCSEd, Microneedling and peels
commented: “The results of this survey show that although most popular treatments
more testing is now available, this isn’t translating into tests
being carried out on healthcare professionals. The state of the UK beauty and aesthetics industries
“…More tests are now available, but we need to ensure has been revealed in the National Hair and Beauty
they are being used much more frequently and robustly to Federation’s (NHBF) 2020 Aesthetics Survey. It found
allow health professionals to continue their vital work and that just under half of aesthetic treatments (49%) are
protect patient safety.” happening within aesthetic practices/clinics run by medics.
He added: “We also need consistency in how official Microneedling and chemical peels are the most commonly
guidance is implemented by Trusts and Health Boards. For provided non-invasive aesthetics treatments.
instance, Public Health England’s official advice for the Dermal fillers and botulinum toxin injections are the
general public is to self-isolate for seven days if a member of most popular invasive treatments, and mostly performed
their household displays covid-like symptoms. by medical professionals.
“However, we are aware of a number of doctors who have Beauty therapists who hold a Level 3 beauty
been advised to carry on working despite being exposed.” qualification as well as those with aesthetics training
perform peel treatments the most, with 114 survey
respondents from this group stating they perform the
service. This was followed closely by nurses (95), aesthetic
practitioners (45) and Level 3 trained beauty therapists
(42).
More experienced and qualified aesthetic therapists
(Level 4) are also offering treatments such as plasma pen
(said 55 survey respondents), cryolipolysis (45) and laser
treatments for tattoo removal (45).
Of those businesses that require medical oversight, more
than half (61%) have a medic on-site, more than a quarter
(28%) have a medic on call and a smaller number (11%) have
a remote medic.

Aesthetic Medicine • June 2020 9