Medical Devices embody a very complex field in Europe, making billions of profit. Varieties and categories are numerous, while their usage is always leading to high stakes involving human safety. All these factors are making the Medical Device framework confusing, especially since it is constantly evolving. The EU is currently deeply modifying its Medical Devices regulations and brands should seriously pay attention to the impact it will have on their activity within the next few years.
On the other side, beauty tools are gaining more interest from European consumers, eager to try the newest technology available on the market. Beauty tools could be categorized as Medical Devices, Medical Devices without an intended medical purpose or General Purpose Products, making their categorization a first step in their commercialization and development process. If your beauty tool is a Medical Device with or without an intended medical purpose, it will be regulated by a set of complex regulations with a long process to follow before being able to sell them. Let’s dive into this fascinating subject, which remains complicated even for professionals in the field! With its experts dedicated to Medical Devices, BIORIUS is always aware of the latest developments in Europe.
Beauty tools: how to know if they are Medical Devices in the EU?
Even if categorizing beauty tools seems to be an easy task at first, many brands are struggling with this key question.
According to the EU standards, a Medical Device should answer to a medical issue or a disease, which would be cured, treated or diagnosed thanks to the device’s action. The mode of operation must be physical because you should not make the confusion between a Medical Device and a medication. While its auxiliary action can be medicinal or metabolic (for instance, distributing a medication in the body), its main purpose cannot.
As a result, the first question you should ask yourself to categorize your beauty tool is: Does my product show a medical allegation and is it physically tackling the problem?
- Example of beauty tool categorized as Medical Device: LED light mask preventing severe acne or rosacea.
- Example of beauty tool categorized as General Purpose Product: Microcurrent face roller
CAUTION: the Medical Device definition is not the same around the world. China, the USA and other countries have different standards; microcurrent face rollers are categorized as Medical Devices in the US for instance (product code OUH).
EU Medical Devices Regulations and Medical Devices without an intended medical purpose
The new EU Medical Devices regulations
Within the European Union, Medical Devices are separated in two different categories: “regular” Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). Their legal framework was drastically modified in 2017, when two new regulations were adopted: the Regulation (EU) 2017/745 for MDR and the Regulation (EU) 2017/746 for IVDR. The aim was to adapt to contemporary technological changes, to strengthen the rules, to avoid any interpretation and to harmonize practices between the EU and international countries.
What about the UK? They are applicable in the UK as a temporary measure. UK authorities are currently deciding on a specific regulation to replace the EU ones, while a different marking will start to be required from July 2023 (UKCA).
Beauty tools and cosmetics categorized as Medical Devices are considered as MDR, but further distinctions are made between them. Indeed, MDR are classified in Class I, Class IIa, Class IIb and Class III, from low to high risk. Each classification comes with specific requirements such as the manufacturer’s duties, Notified Body obligation or additional registration in some EU member states.
Your beauty tools or cosmetics can be classified from Class I to Class III, the most regulated and time-consuming one. If you want support in defining your product’s classification, BIORIUS is here to help.
Hence, brands must take in account the Class’s specific requirements, as well as the new regulations which came into force recently with an adaptation period until 2025. However, the infamous annex XVI of the Regulation (EU) 2017/745 is not implemented yet, but will drastically change the face of the European market for the concerned manufacturers…
Medical Devices without an intended medical purpose
In addition to the definition provided earlier, a Medical Device can have no intended medical purpose. This borderline category involves cosmetics and beauty tools initially displaying an aesthetic action or a medical purpose “hidden” as an aesthetic one. For safety reasons, 6 groups of products were added in the annex XVI of the Regulation (EU) 2017/745, to be considered as Medical Devices without an intended medical purpose. Each classification will be subject to specific requirements. This annex XVI is not officially out yet because the specific requirements (Common Specifications) are still missing, but it is believed to be released before the end of 2022.
We already wrote an article about this subject, but for a reminder here are the 6 products targeted by this Annex:
- Contact lenses or other items to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings –> Implants…
- Substances, combinations of substances or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those of tattooing –> Dermal fillers, micro needling and mesotherapy tools.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation 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–> LED hair removal devices.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain –> Treating depression…
CAUTION: additional categories of products which are likely to induce a risk could be added to the Annex XVI. If your cosmetic or beauty tool is in the Annex XVI, or if you believe that it could be included to it in the future, you should prepare yourself to become compliant now.
If I sell cosmetics or beauty tools considered as Medical Devices, do I have time to comply with the new EU regulations and the Annex XVI?
The answer is yes, thanks to the transition periods. They were implemented to grant you sufficient time during which you should decide to proceed and start to conduct the required studies and to bring any necessary change. Nevertheless, you should be aware that:
- Every brand and manufacturer have until 2024 before their certificate granted under the old Medical Device regulation loses its validity. Thousands of companies are already trying to gain compliance under the Regulation (EU) 2017/745 and thousands more will wait the last minute to do it. Longer process time, already 18 months on average, is to be expected.
- Cosmetics and beauty tools manufacturers also must comply to the Annex XVI once it gets implemented, but there are still uncertainties nowadays. Thus, if you wait until the last moment, like other thousands of companies, long process times could prevent you to put your product on the market according to your initial deadline.
These two factors combined, getting approved by your Notified Body (if you need one) could take up to several years. Indeed, on top of overworked Notified Bodies and an expected rush, Medical Devices without an intended medical purpose are not the priority. Regular Medical Devices essential to human safety or healthcare will be dealt with first and the rest may be last in line.
Do not wait! BIORIUS can help you to develop your MD by providing EU/UK Person Responsible (for companies based out of Europe), post-market surveillance, MDR classification or creation of your technical documentation services. We can also assist you to choose your Notified Body if you need one. To comply with the latest regulatory changes, we can confirm your MD classification, update your biosafety assessment or analyze the gap between your current system and the new regulations. If you want to sell a Medical Device without an intended medical purpose, we can also provide assistance from A to Z.
Working with us will make you save time and money! You have a special request? Do not hesitate to contact us to put in place custom-made solutions: firstname.lastname@example.org