The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR). The first of these regulations states common specifications for groups of products without an intended medical purpose, whereas the second lays down the rules for the reclassification of active products without an intended medical purpose. We have previously assessed this matter in a public consultation on common specifications and our analysis of the draft act on the reclassification of Annex XVI products.
Common specifications for Annex XVI products
The newly published regulation divides the common specifications into the following categories of devices:
- Groups without an intended medical purpose (Annex I)
- Contact lenses (Annex II)
- Products 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 (Annex III)
- Substances or combinations of substances 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 (Annex IV)
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty (Annex V)
- High intensity electromagnetic radiation emitting equipment intended for use on the human body (Annex VI)
- Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain (Annex VII)
Transitional period
Furthermore, different transitional provisions were put in place for Annex XVI devices:
- Products for which a clinical investigation is necessary may be placed on the market or put into service until 28 June 2028 provided that the product has been already marketed before 22 June 2023, continues complying with the requirements of EU & national law that applied to the product before 22 June 2023 and there are no significant changes in the design and intended purpose of the product.
- From 22 June 2024 until 22 December 2024: the product can be marketed in the EU, if the sponsor received a confirmation from the EU authority that the application for the clinical investigation is complete and that the clinical investigation falls within the scope of the MDR.
- From 23 December 2024 until June 2026: the product can be marketed in the EU, if the sponsor has started the clinical investigation.
- From 23 June 2026 until 22 June 2028: the product can be marketed in the EU, if there is a written agreement signed by the manufacturer and the notified body for the performance of the conformity assessment.
- Products for which a notified body needs to be involved in the conformity assessment procedure may be placed on the market or put into service until 22 June 2025 provided that the product was already lawfully placed on the market before 22 June 2023, continues complying with the requirements of EU & national law that applied to the product before 22 June 2023 and there are no significant changes in the design and intended purpose of the product.
- Products with an NB Certificate under the Medical Devices Directive (MDD) may be placed on the market until 28 June 2028 (even after the NB Certificate has expired) provided that the product is lawfully marketed before 22 June 2023, continues complying with the MDD, and there are no significant changes in the design and intended purpose of the product. Moreover, after the expiry of the NB Certificate, there should be a written agreement signed by the manufacturer and the notified body that issued the Certificate on the surveillance of the product as per the previous points.
- From 22 September 2023 until 22 June 2025: the product can be marketed in the EU, if there is a written agreement signed by the manufacturer and the notified body for the performance of the conformity assessment.
- From 22 September 2023 until 22 June 2025: the product can be marketed in the EU, if there is a written agreement signed by the manufacturer and the notified body for the performance of the conformity assessment.
This regulation applies from 22 June 2023 except its Article 2(3) on products certified under MDD, which shall apply from 22 December 2022.
Reclassification of groups of active Annex XVI products
Moreover, the regulation on the reclassification of groups of active products stated in Annex XVI MDR states the following:
- High intensity electromagnetic radiation emitting equipment intended for the use on human body for skin treatment is reclassified as class IIa under MDR
- Equipment intended to be used to reduce, remove or destroy adipose tissue is reclassified as class IIb under MDR
- Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain is reclassified as class III under MDR
This regulation will enter into force on 22 December 2022.
You can find these Commission Implementing Regulations and more legislation in the MDR law section on the MDlaw library.
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