An aesthetic Medical Device is any medical instrument intended to provide the desired change in visual and aesthetic appearance without therapeutic or reconstructive purpose. These procedures can be the management of scars, skin laxity, wrinkles, treatment of moles, removing excess fat, cellulite, and unwanted hair and treat skin discolouration.
Impact of EU MDR 2017/745 on dermal fillers and injectable implants
In an effort to reshape and improve essential health and safety practices and guidelines, the European Medical Device Regulation has widened the scope of what we understand to be a medical device to include so-called ‘aesthetic products/devices’.
Aesthetic products or devices are defined as any product or device “without an intended medical purpose” but still used in the same manner or has similar characteristics/risks to use as a medical device already under the scope of the previous regulation. The main consequence for manufacturers of aesthetic products is that any product affected by the new regulation will need to be brought into full compliance with MDR 2017/745, including adding (unless already installed) the required standard of notification post-market surveillance practices.
The changes introduced were designed to ensure a higher level of safety for the consumer and a higher level of transparency and harmonization with EU practices for manufacturers. The regulation will ensure that devices of all kinds will live up to their claims and are suitable for their intended purpose under regular conditions of use without compromising the user’s safety.
We can support manufacturers in placing and keeping their dermal fillers and injectable implants on the European Market and obtaining the EU MDR 2017/745 CE-mark certificate.
INVASIVE SURGICAL TREATMENTS
INVASIVE SURGICAL MEDICAL DEVICES
Include implants or even minimally invasive procedures in which a tiny cut is made in a part of the body.
• Breast Implants
• Radio Frequency
NON-INVASIVE AND MINIMALLY INVASIVE TREATMENTS
NON-INVASIVE SURGICAL MEDICAL DEVICES
Refers to medical devices that do not create a physical break in the skin.
• Botulinum Toxin type A – Botox
• Soft Tissue Fillers – Dermal Fillers
• Chemical Peels
MINIMALLY INVASIVE TREATMENTS
MINIMALLY INVASIVE MEDICAL DEVICES
Refers to medical devices that require minor incision and can be provided in a medical office or aesthetic medical spa setting depending on local guidelines.
• Energy-based treatment systems
• Physician-dispensed topicals
• Breast aesthetics
ENERGY-BASED AND NON-ENERGY AESTHETIC DEVICES
Refers to Energy-Based Aesthetic Devices, specifically with adjustable wavelengths and fibre optic systems that allow different treatment options.
• Laser-Based Aesthetic Device
• Radiofrequency (RF)
• Based Aesthetic Device
• Light-Based Aesthetic Device
• Ultrasound Aesthetic Device
Refers to Aesthetic Medical Devices that make a partial or complete incision in the skin and must be inserted into the body.
• Botulinum toxin
• Dermal fillers and aesthetic threads
• Implants (Facial implants – Breast implants – Other implants)