Similar to Annex XVI of the EU Medical Devices Regulation (MDR), since May 2021, the Swiss Medical Devices Ordinance regulates certain products that have an aesthetic function and no intended medical purpose. Art. 15 and Annex 5a of the MedDO address the reclassification of certain active products without an intended medical purpose. Some examples for such products are contact lenses, equipment for liposuction, products introduced into the human body for modifying the anatomy, and similar.
Since December 2022, the EU MDR has included the common specifications and classification rules for product groups without an intended medical purpose. On 1 November 2023, the Swiss Medical Devices Ordinance was revised to include these same new provisions.
Annex I of MedDO
Annex I of the Swiss MedDO lists products without an intended medical purpose. The new provisions in the Ordinance aim to ensure these products meet the same manufacturing, quality, and surveillance requirements of devices with an intended medical purpose. Therefore, this change will affect economic operators and end users of, among others, the following areas:
- Opticians
- Cosmetic surgery
- Cosmetics
- Body sculpting
Extended transitional period
In the revised MedDO from 1 November 2023, the transitional period for devices without an intended medical purposes (or Annex I devices in the Swiss Ordinance) is adapted to the Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023. As such, it is possible for manufacturers of devices that fall under Annex 1 MedDO to either fully comply with MedDO or to benefit from the transitional provisions if:
- Device has been legally marketed in Switzerland prior to 1 May 2024 and continues to comply with applicable legislation
- Device has not been substantially changed
The deadlines vary from December 2027 to December 2029, based on different characteristics of the device, such as the involvement of notified body and need for clinical trials. As such,
Device requirements and making available under the manufacturer’s name
According to Annex I of the MedDO, manufacturers must conduct the appropriate conformity assessment and draw up a declaration of conformity. Annex I devices must involve a notified body when assessing the conformity of their products. However, there are different requirements between medical devices and devices without an intended medical purpose, described in the common specifications adopted with effect from 1 November 2023.
From November 2023, anyone marketing Annex I products under their own name, trade name, or trade mark will assume the obligations of manufacturers. If the distributor or the importer places products on the market but has an agreement with the manufacturer under which the manufacturer is indicated on the labelling, then the manufacturer is responsible for compliance with the requirements applicable to manufacturers.
Do you have any questions on requirements to place medical devices on the Swiss, UK, or EU markets? Contact us!
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