MedDO on products without an intended medical purpose

In November 2023, the Swiss Medical Devices Ordinances (MedDO and IvDO) were revised to guarantee the same transitional periods as the EU Medical Devices Regulations (MDR and IVDR). The Swiss Federal Office of Public Health already stated in March 2023 that Switzerland will have adapted the Medical Devices Ordinances to the new EU transitional periods, including extension of certificate’s validity for legacy medical devices and removal of sell-off provisions for IVDs. However, the Federal Council announced in November that Switzerland is aligning their legislation with the transitional period announced in June 2023 in the EU for products without an intended medical purpose.

What are products without an intended medical purpose?

Certain products without an intended medical purpose are regulated like medical devices to ensure that they do not pose significant potential health risks. In Switzerland, Annex I of the MedDO regulates these products. Similar to Annex XVI of the MDR, Annex I of the MedDO lists six categories of products without an intended medical purpose, also defined as products with an aesthetic function.

The six categories include:

• Contact lenses or other items intended to be introduced into the eye
• Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts (tattooing products and piercings are excluded)
• Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling (those for tattooing are excluded)
• Equipment intended to be used to reduce, remove or destroy adipose tissue
• High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment for skin resurfacing, tattoo or hair removal or other skin treatment
• Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields

Both the MDR and the MedDO do not provide a definition for such products. MDCG guidance on classification of Annex XVI products is under development.

Transitional period for products with an aesthetic function

With the new extensions announced in the European Union, Switzerland adapted its transitional provision to the Commission Implementing Regulation (EU) 2023/1194 of June 2023. The new legacy period for Annex I devices varies based on the device’s characteristics.

Products that need a clinical trial:

• Manufacturers can place products for which they intend to perform, or are performing, a clinical investigation on the market or put them into service until 31 December 2029 with the following conditions:
  • From 22 June 2024 until 22 December 2024: the sponsor has received confirmation that the application for the clinical investigation of the product is complete, and that the clinical investigation falls within the scope of the MDR.
  • From 23 December 2024 until 31 December 2027: the sponsor has started the clinical investigation.
  • From 1 January 2028 until 31 December 2029: there is a written agreement with a notified body for the conformity assessment in accordance with the requirements set in Annex VII.

Products that do not need a clinical trial, but the involvement of a notified body is mandatory:

• Manufacturers can place products for which they do not intend to perform a clinical investigation – but need to be assessed by a notified body – on the market or put them into service until 31 December 2028 if:
  • From 1 January 2027 until 31 December 2028:  there is a written agreement with a notified body for the conformity assessment in accordance with the requirements set in Annex VII.

CE Certificate issued by a Notified Body:

• Manufacturers of products with a Certificate issued under the Directive and expired after 26 May 2021 and before 20 March 2023 can place such products on the market and put them into service if they meet the extension requirements.

To benefit from the transitional period, manufacturers should comply with legislation applicable to the product before June 2023 and have not performed any significant changes to the design and intended purpose.

Simona Varrella
Publications Department
09/11/2023

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References:

Swissmedic (2023) Revision of MedDO and IvDO. Retrieved 08.11.2023.