The EU Commission released a draft implementing regulation for products without an intended medical purpose, covered in the Medical Device Regulation (MDR), Annex XVI.
The draft implementing regulation proposes classifications for these products, proportionate to their risk. The draft can be found: HERE
Examples of products and their proposed classifications are:
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- Equipment used to reduce, remove or destroy adipose tissue
- e.g., liposuction equipment – Class IIb
- High intensity electromagnetic radiation emitting equipment intended for use on the human body
- e.g., laser hair removal – Class IIa
- e.g., skin modification – Class IIb
- 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
- e.g., electrical stimulators to improve focus and productivity – Class III
- Equipment used to reduce, remove or destroy adipose tissue
Other non-medical products are already included in MDR, Annex VIII, Classification Rules. For example, breast implants and collagen dermal fillers are regulated as Class III.
These devices must undergo Notified Body conformity assessment.
The draft is open for public feedback until 8 September 2022.
