Products without a medical purpose
Products listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR) are products that do not have a medical purpose but are similar to medical devices in terms of characteristics and risk profile. This product group includes fillers, equipment intended to be used to remove or reduce adipose tissue and equipment intended to be used to remove tattoos or body hair. The manufacturer defines the intended purpose of medical devices referred to in Annex XIV and demonstrates with a declaration of conformity that the manufactured device bears a CE-marking in accordance with the requirements.
| Products listed in Annex XVI to the Medical Devices Regulation (2017/745) | Example |
|---|---|
| 1. Contact lenses or other items intended to be introduced into or onto the eye. | Coloured contact lenses (without a prescription for contact lenses) |
| 2. 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. | Body modification implants (e.g. horn implants) |
| 3. 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. | Fillers |
| 4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. | Equipment intended to be used to remove or reduce adipose tissue, e.g. cryolipolysis devices |
| 5. 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. | Intense pulsed light (IPL) machines for hair removal |
| 6. 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. | Transcranial direct current or magnetic stimulation |
The requirements set out in the Regulation apply to the manufacture, import, distribution and marketing of Annex XVI products. These requirements do not apply to products already put into service.
Clinical investigations
Manufacturers of Annex XVI products are obliged to collect data on clinical evaluation under the MDR in accordance with the requirements set out in the Common Specifications. The evaluation has to be based on relevant clinical data on performance and safety, including information on post-market surveillance, post-market clinical surveillance and, where appropriate, specific clinical investigations.
In situations where it is not possible to properly justify the equivalence of clinical data with data on medical devices, clinical investigations also must be carried out for Annex XVI products.
For clinical investigations, the instructions related to clinical investigations of medical devices apply. More detailed information is available on the Clinical investigations of devices page.