EU Commission publishes MDR Article XVI Common Specifications
14 December 2022
Posted by: inetika
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022, laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR) and Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of the MDR as regards reclassification of groups of certain active products without an intended medical purpose, have now been published by the EU Commission.
The 2022/2346 Regulation applies from 22 June 2023, with a transition period lasting until June 2028, with certain exceptions.
Annex I of the regulation provides requirements for risk management, while subsequent annexes include specific requirements for the types of product listed in MDR Annex XVI, including:
- 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
- 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
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty
- 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
- 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
The 2022/2347 Regulation applies with immediate effect and explains that classification rules 9 and 10 for active devices in Sections 6.1. and 6.2. of Annex VIII to the MDR refer to an intended medical purpose for therapy and diagnosis respectively, and thus cannot be applied to active products without an intended medical purpose. Such products were therefore originally to be classified as class I in accordance with rule 13 in Section 6.5. of MDR Annex VIII. However, certain Member States jointly requested the reclassification of several active products without an intended medical purpose by way of derogation from MDR Annex VIII, “in order to ensure an appropriate conformity assessment of those active products that is consistent with their inherent risks”.
As a result, this new regulation reclassifies certain MDR Annex XVI products, as follows:
- High intensity electromagnetic radiation emitting equipment as referred to in Section 5 of MDR Annex XVI that is intended for the use on the human body for skin treatment is reclassified as class IIb, unless it is intended for hair removal only in which case it is reclassified as class IIa;
- Equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of MDR Annex XVI is reclassified as 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 as referred to in Section 6 of MDR Annex XVI is reclassified as class III.