In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two guidance documents on Annex XVI devices. Annex XVI products are devices without an intended medical purpose regulated by the Medical Devices Regulation (MDR). The MDR does not define them specifically. However, XVI lists six categories of products considered devices without an intended medical purpose, or aesthetic devices. For the classification, manufacturers have to consider different factors, such as the characteristics mentioned in those common specifications as well as product type, technology, functioning modalities, target body part, organ or tissue, and the intended purpose.
These two guidance documents further clarify Annex XVI’s scope, with a wide range of examples and exclusions.
MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products
The first guidance is MDCG 2023-5, a guidance on qualification and classification of Annex XVI products. This guidance lists various examples for each of the six categories.
Group I: contact lenses
The first category of Annex XVI includes contact lenses. This category excludes contact lenses containing tools, such as an antenna or microchip, contact lenses that are active devices, and other items introduced into or onto the eye.
Some examples of group I are short-term use coloured non-corrective contact lenses or non-corrective contact lenses with prints, which are class IIa. The same product, if long-term- would be classified as a IIb.
Group II: products introduced into the body to modify the anatomy
The second group of Annex XVI entails products totally or partially introduced into the human body through surgically invasive means to modify the anatomy. This group excludes tattooing products, piercings, and products introduced into the human body through surgically invasive means for the fixation of body parts. Similarly, the common specifications for this group do not apply to active implantable devices.
Some examples from this category are breast implants, surgical meshes for breast lifting, and absorbable threads. These three products would be class III devices.
Group III: products for facial or other dermal or mucous membrane filling
The third category of Annex XVI includes substances, combinations of substances, or items for facial or other dermal or mucous membrane filling by subcutaneous, submucous, or intradermal injection or other introduction. This group does not include tattooing-related products.
Permanent dermal fillers (class IIb) are an example from this group. Resorbable dermal fillers, instead, are class III products.
Group IV: equipment to reduce, remove or destroy adipose tissue
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty are covered by the fourth category of Annex XVI.
Equipment used for cryolipolysis, suction-assisted lipoplasty (SAL), power-assisted lipoplasty (PAL), and suction pumps are Annex XVI products, classified as IIb devices.
Group V: high-intensity electromagnetic radiation emitting equipment for various treatment
Annex XVI’s common specifications apply to high-intensity electromagnetic radiation emitting equipment used on the human body. Specifically, this category includes coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoos, hair removal, or other skin treatments. Moreover, this group also covers products for skin rejuvenation, removal of permanent make-up, and non-medical treatment of nevi flammei, haemangioma, teleangiectasia, pigmented skin areas, and scars that are not injuries.
Some examples are:
- Laser equipment for hair removal, skin resurfacing, tattoo removal, hypertrophic and keloid scars, and improvement of pigmentation problems.
- IPL equipment for hair removal, skin rejuvenation, and improvement of pigmentation problems.
- LED equipment for skin rejuvenation, stimulation of hair growth, and improvement of the appearance of acne scars
All these products would be classified as IIb devices. Interestingly, the common specifications do not apply to equipment using infrared optical radiation to warm the body or parts of the body and also not to sunbed
Group VI of Annex XVI: equipment intended for brain stimulation
The last product category of Annex XVI covers equipment for brain stimulation applying electrical currents or magnetic or electromagnetic fields that penetrate the skull to modify neuronal activity in the brain.
Among such products, there are devices for transcranial electrical, magnetic, or electromagnetic stimulation to enhance cognitive performance and devices. These products are classified in the highest class – Class III.
MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products
The second guidance document addresses the demonstration of equivalence for Annex XVI products. The MDR foresees that clinical evaluation of medical devices can include clinical data related to an equivalent device. Manufacturers have to demonstrate this equivalence between their device and the device from which the data are sourced.
When it comes to Annex XVI products, manufacturers should consider that they should demonstrate the equivalence between two devices following the MDR criteria. Particularly, they have to consider technical, biological, and clinical characteristics. Technical and biological characteristics concern aspects that can directly compare products without an intended medical purpose. Some clinical characteristics, instead, address specific aspects related to the medical purpose of the device. Importantly, it is usually not possible to compare a medical device and a product without an intended medical purpose, and thus no equivalence can be deducted. On the contrary, it is possible to demonstrate equivalence between a product without an intended medical purpose and a device with both a medical and non-medical purpose (dual-purpose devices).
To clarify how manufacturers should evaluate these characteristics, the new MDCG 2023-6 provides the following table:
The full text of the guidance documents can be found in our Library of Documents dedicated to classification and special categories.
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