MDR Annex XVI provides a list of products that are a specific category of items regulated under the EU Medical Device Regulation (MDR) 2017/745 even though they do not have an intended medical purpose. These are products are like medical devices in terms of functioning, risk profile, and application but are used for non-medical applications, e.g., aesthetic, cosmetic, etc. MDR Annex XVI brings them under the same rigorous safety, quality, and conformity assessment requirements as actual medical devices to protect public health.
List of groups of products without an intended medical purpose referred to in article 1 (2):
| Group | Description | Examples |
| 1 | Contact lenses or other items intended to be introduced into or onto the eye | Coloured / decorative (non-corrective) contact lenses |
| 2 | Products intended to be totally or partially introduced into the human body through surgically invasive means to modify anatomy or fix body parts (except tattooing & piercings) | Cosmetic breast implants, gluteal/calf/chin implants, subdermal implants, absorbable threads for lifting |
| 3 | Substances, combinations of substances, or items used for facial or other dermal/mucous membrane filling by injection or other introduction (excluding tattooing) | Dermal fillers (hyaluronic acid, etc.), injectable fillers for wrinkles or volume |
| 4 | Equipment intended to reduce, remove, or destroy adipose tissue | Liposuction equipment, cryolipolysis (fat-freezing) devices, lipolysis/lipoplasty machines |
| 5 | High-intensity electromagnetic radiation (IR, visible light, UV) emitting equipment for use on the human body (lasers, IPL, etc.) | Lasers/IPL for hair removal, skin resurfacing, tattoo removal, or other skin treatments |
| 6 | Equipment for transcranial brain stimulation using electrical currents or magnetic/electromagnetic fields to modify neuronal activity | Certain TMS (transcranial magnetic stimulation) devices for non-medical cognitive enhancement |
These products must comply with the full MDR requirements (risk management, technical documentation, clinical evaluation where needed, CE marking via a Notified Body, post-market surveillance, etc.). Annex XVI expands the MDR’s scope to cover popular aesthetic and “lifestyle” products that previously fell into a regulatory grey area, ensuring they meet high safety standards despite lacking a medical claim.
Read the MHRA guidance: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/748131/Guidance_leaflet_on_Annex_XVI_products_.pdf
