Two regulations regarding common specifications for medical devices are implemented in December 2022, consisting of the following:
- 1. Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with the MDR. This regulation is a common specification for the groups of products without an intended medical purpose listed in Annex XVI of the MDR.
The annexes of this regulations cover:
- (1) Common specifications for all those groups of products without an intended medical purpose.
- (2) Common specifications for contact lenses.
- (3) Common specifications for products intended to be totally or partially introduced into the human body through surgically invasive
- means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings.
- (4) Common specifications for 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.
- (5) Common specifications for equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- (6) Common specifications for high intensity electromagnetic radiation (for example, 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.
- (7) Common specifications 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.
- 2. Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of the MDR. This regulation are rules for the application of the MDR with regards to reclassification of groups of certain active products without an intended medical purpose as follows:
- (1) High intensity electromagnetic radiation emitting equipment - as referred to in Section 5 of Annex XVI to the MDR -, which is intended for the use on the human body for skin treatment, will be reclassified as class IIb. That is, unless it is intended for hair removal only, in which case it is reclassified as class IIa.
- (2) Equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of Annex XVI to the MDR, is reclassified as class IIb.
- (3) Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields, which penetrate the cranium to modify neuronal activity in the brain - as referred to in Section 6 of Annex XVI to the MDR - is reclassified as class III.
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