The European Commission adopted Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Medical Device Regulation (MDR) (EU) 2017/745 (CS for the groups of products without an intended medical purpose listed in Annex XVI MDR) and Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 (Rules for the application of the MDR as regards the reclassification of groups of certain active products without an intended medical purpose).
Implementing Regulation (EU) 2022/2346 establishing the Common Specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 has been published. These CS, which are mandatory, provide clarifications regarding requirements for risk management, information to be provided to users, and clinical evaluation. These CS also introduce transitional provisions to allow devices to remain on the market for which conformity assessment requires a NB. This regulation enters into force 20 days after its publication in the OJEU. It shall apply from 22 June 2023. Note that Article 2(3) is applicable from 22 December 2022.
The European Commission has adopted the Implementing Regulation (EU) 2022/2347 reclassifying certain active products listed in Annex XVI of MDR (EU) 2017/745. The classification rules 9 and 10 on active devices in Sections 6.1 and 6.2 of Annex VIII of the MDR refer to an intended medical purpose, respectively for therapy and diagnosis, and thus cannot be applied to active products without an intended medical purpose.
The purpose of this act is to ensure the classification of these devices in accordance with the risks they represent, thus subjecting them to the same requirements as devices with a comparable medical purpose.
The following devices are subject to reclassification:
- High intensity electromagnetic radiation emitting equipment that is intended for the use on the human body for hair removal or skin treatment (eg. lasers and IPL equipment, …);
- Equipment intended to be used to reduce, remove, or destroy adipose tissue (eg. equipment for liposuction, …);
- 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 (eg. equipment for transcranial stimulation, …)
This Regulation shall enter into force on the day of its entry into force, i.e., the twentieth day following its publication in the Official Journal of the European Union (OJEU).
What does this mean to you?
Implementing regulation (EU) 2022/2346 is of relevance for manufacturers with devices that fall within the definition of the groups of devices listed in Annex XVI that require Notified Body involvement.
Implementing regulation (EU) 2022/2347 describes how, by way of derogation from Section 6.5 of Annex VIII MDR, the following groups of active products without an intended medical purpose listed in Annex XVI MDR are reclassified.
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