On 14th December 2023, the Medical Device Coordination Group (MDCG) has released two new documents: MDCG 2023-5 (Guidance on qualification and classification of Annex XVI products) & MDCG 2023-6 (Guidance on demonstration of equivalence for Annex XVI products)
Annex XVI of EU MDR 2017/745 outlines six categories of products which are governed by EU MDR even though they lack an intended medical purpose. The European Commission determined that products falling within these categories, for which manufacturers claim only aesthetic or non-medical purposes but exhibit similarities to medical devices in terms of functionality and risk profile, should be covered by the EU MDR. Following are the examples for Annex XVI Products :
|Contact lenses or other items intended to be introduced into or onto the eye.
|Non-Prescription Colour 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.
|Solid body contour modifying implant (e.g.
|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.
|Body shaping equipment
|High intensity electromagnetic radiation (e.g. infra-red, visible light and ultraviolet) 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) equipment (e.g. for
|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 stimulation equipment (surgically non-invasive) for non-medical purposes
Both the new guidelines are a must-read for the manufacturers of device that fall under Annex XVI medical devices (products without an intended medical purpose).
In addition, the guidance is particularly focused on dual-purpose devices, addressing the complexities of classifying products that serve both medical and non-medical purposes. It also offers practical advice on interpreting relevant terms and concepts, aiding manufacturers and notified bodies in ensuring regulatory compliance within the EU.
Example: Breast Implants
These would be classified as Class III, Rule 8 according to MDCG 2023-5. These fall under section 2 of Annex XVI of EU MDR 2017/745, which states products intended to be totally or partially introduced in the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts.
In conclusion, when embracing these guidelines, it is crucial to understand the guiding principles and consider the similarities with medical devices.
 EU MDR 2017/745
 EU 2022/2346
 EU 2022/2347
 MDCG 2023-5: Guidance on qualification and classification of Annex XVI products
 MDCG 2021-24: Guidance on classification of medical devices
 MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products
 MDCG 2020-5: Clinical Evaluation – Equivalence
Author – Shaily Patel
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