Contact lenses, dermal fillers, machines for laser treatment for body hair removal, and others are products without medical purpose that fell under the new EU Medical Device Regulation as of 25 May 2021. The Medical Device Regulation 2017/745 has an special section under Annex XVI where the regulation clearly defines other devices, without medical purpose, that also must comply to the regulation.
Non-medical products
The medical devices without an intended medical purpose that fall under the Medical Device Regulation 2017/745 are:
Contact lenses or other items intended to be introduced into or onto the eye, such as non-prescription colored contact lenses
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. An example includes body contour modifying implants such as horn 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 for tattooing.
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) 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.
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. For example, transcranial (nonsurgical invasive) stimulation.
Manufacturers of Annex XVI medical devices sold in the EU will have to comply with the requirements laid out in the MDR for general medical devices.
There are number of steps to take in order to comply with the EU MDR 2017/745 requirements:
Specify the intended purpose of your device
Identify the product classification
Establish a risk management system and ensure your device complies with common specifications (CSs)
Conduct a clinical evaluation3 for your device
Ensure your device complies with other relevant MDR requirements
Pass a conformity assessment carried out by a notified body, if so required
Draw up a declaration of conformity and affix a CE marking on the device
Place your product on the market anywhere in the EU
Meet the post-market surveillance (PMS) and vigilance requirements.
Comply with the obligations relating to the unique device identifier (UDI) system
Appoint a person responsible for regulatory compliance (PRRC)
Submit key information about the manufacturer, authorized representative and importer to the electronic database (EUDAMED)
For a complete list of manufacturers’ obligations, refer to Article 10 of the Medical Device Regulation 2017/745 (MDR). The obligations of importers and distributers are described in Articles 13 and 14, respectively.
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