More stringent regulations for non-medical products
Cosmetic contact lenses, liposuction devices, wrinkle fillers, tanning booths, lasers, and equipment for tattoo removal and hair removal – The regulations are being tightened for all these non-medical products!
Manufacturers and distributors of products that are not medical devices will have to comply with the requirements of Regulation (EU) 2017/745 if they wish to continue to place their devices on the market.
What products are we talking about?
- To date, these include:
- Cosmetic lenses and implants, with the exception of tattoo products and piercings;
- Skin or mucous membrane filling products, such as subcutaneously injected hyaluronic acid;
- Equipment for liposuction, lipolysis and lipoplasty;
- Equipment such as lasers and intense pulsed light equipment used for skin resurfacing, tattoo removal, hair removal or other skin treatments;
- Equipment for transcranial brain stimulation using electrical currents or magnetic or electromagnetic fields.
- All these products are listed in Annex XVI of Regulation (EU) 2017/745, bearing in mind that this list may be amended.
What will be the impact for these products?
These products will have to comply with the same requirements as medical devices (MDs).
Thus, manufacturers will have to determine the class of their product(s) with classification rules tailored to MDs, choose the conformity assessment procedure, implement a quality management system, and keep technical documentation demonstrating that their products meet the general safety and performance requirements of Regulation (EU) 2017/745.
Products belonging to Class I will be self-certified while a notified body will have to intervene for other products which are considered more critical.
Manufacturers will have to draw up the declaration of conformity, affix the CE marking to their device and set up a post-market surveillance system.
When will these products have to comply with Regulation (EU) 2017/745?
The Regulation will apply as soon as the European Commission publishes “common specifications” (see below) specific to these products. More specifically, the common specifications will apply as from six months after the date of their entry into force or from 26 May 2021, whichever is the latest.
What are common specifications?
Common specifications are a set of technical and/or clinical requirements, other than a standard, that provide a means of complying with the legal obligations applicable to a device, process or system. By applying these specifications, manufacturers will be able to demonstrate the conformity of their product(s). They can also prove that they have adopted solutions that guarantee a level of safety and performance at least equivalent to that provided for by these specifications.
The common specifications for these non-therapeutic products will cover, at least, the application of risk management for the product group in question and, where necessary, clinical evaluation with regard to safety.
What are the requirements for a device with medical and non-medical purposes?
Breast implants, hair removal lasers, hyaluronic acid for injection and all devices for which both medical and non-medical purposes are claimed will have to comply with the requirements applicable to both types of devices. They will have to have a technical dossier supporting the non-medical application separate from that supporting the medical application.
Are you ready?
Thanks to its experience with medical devices, Efor can assist you in implementing these new requirements.
Feel free to contact us via the contact form.
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