The new European Regulation 2017/745 will bring many innovations. One of these concerns the extension of the Regulation application field. According to Article 1, the Regulation 2017/745 will apply also to groups of products without an intended medical purpose listed in Annex XVI. These products will be classified as “devices”, although they do not have any medical purpose. A summary of the categories of products listed in Annex XVI of the European Regulation 2017/745 is reported below:
- 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, except for 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;
- High intensity electromagnetic radiation emitting equipment used on the human body 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
These products will be classified as medical devices; this means that the manufacturers will have to classify, register and manage these products as medical devices according to the requirements of the new European Regulation 2017/745. However, the manufacturers could state that the intended use of the device is different from medical purpose.
It should be noted that due to the specific nature of these devices, the clinical evaluation will be principally be based on the safety data, whereas the requirement related to the demonstration of the clinical benefit will refer to the demonstration of the performance of the device.
Considering that most of the products listed in Annex XVI of the European Regulation 2017/745 do not currently fit into clearly defined categories, the New Regulation could be of great impact for many companies.
RPN is at your disposal to offer you support to better manage the transition from the current directive to the new regulation.