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Medical devices, products not intended for medical use

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The Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 has been published in the Official Journal of the European Union (OJEC) which establishes the common specifications for the groups of products that do not have a listed medical use in Annex XVI of Regulation (EU) 2017/745 on medical devices.

This implementing regulation, divided into a main part and seven annexes, indicates the application of risk management and clinical evaluation relating to safety for products without intended medical use listed in Annex XVI.

In general, Regulation (EU) 2017/745 will apply to these product groups starting from 22 June 2023. However, the implementing regulation (EU) 2022/2346 defines specific transitional provisions if in the conformity assessment procedure the participation of a Notified Body is necessary and if a manufacturer intends to carry out a clinical investigation. Furthermore, this regulation establishes transitional provisions in the event that the notified bodies have issued certificates for these products in accordance with Directive 93/42/EEC.

At the same time, the Implementing Regulation (EU) 2022/2347 of the Commission of 1 December 2022 was also published in the OJEC containing the methods of application of Regulation (EU) 2017/745 as regards the reclassification of groups of certain active products which they have no intended medical use.

This implementing regulation defines the risk classes for liposuction, lipolysis or lipoplasty equipment and for those that emit high intensity electromagnetic radiation such as lasers and pulsed light for photorejuvenation, epilation or other dermal treatment. It also defines the risk class for brain stimulation equipment that modifies the neuronal activity of the brain.


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