One of the key new concepts introduced by the EU Medical Device Regulation 2017/745 is the regulation of “Products without a medical intended purpose” which are listed in Annex XVI. The Regulation will begin to apply for the below devices from the date on which the relevant Common Specifications (CS) are adopted:
- Contact lenses or other items intended to be introduced into or onto the eye.
- 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.
- 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.
Many of the above products are noted to be of a cosmetic nature and will now be regulated under the MDR. Manufacturers of such devices are required to take into account the current state of the art and existing harmonised standards for analogous devices with a medical intended purpose and which are based on similar technology. This implies that requirements expected to be met by a similar medical device will also be expected of the product without a medical intended purpose. If a product has both a medical and non-medical intended purpose, then it shall meet the requirements of the MDR and any applicable CS.
Until the date of application of the relevant Common Specifications, existing measures taken by Competent Authorities with respect to the application of the EU Medical Device Directive 93/42/EEC (MDD) will continue to apply. The CS shall address, at least, the application of risk management as set out in Annex I of the MDR and clinical evaluation, when appropriate. General Safety and Performance Requirements (GSPR) 1 and 8 shall be understood “to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.” [GSPR 9]
Article 1(5) of the EU MDR empowers the Commission to adopt delegated acts in accordance with Article 115 and amend the list in Annex XVI. In such cases, the Commission may add products or groups of products to this list when it is shown that there is a similarity between a medical device and a product without a medical intended purpose.
Although the manufacturer of an Annex XVI product may be required to demonstrate a clinical benefit in accordance with Article 61 and Annexes XIV and XV, this shall be understood as a requirement to demonstrate the performance of the product. The clinical evaluations of these products will be based on any data relevant to safety including post-market surveillance data and PMCF. Unless the manufacturer can rely on existing clinical data from an analogous medical device, they shall conduct clinical investigations to collect clinical data.
Annex XVI products shall still be registered on Eudamed, however, these shall be clearly indicated as without a medical intended purpose.
To date, although draft Common Specifications handling products without a medical device have been issued for comment [closed in February 2022], they have not been officially published.