New MedDO Amendments Implemented by Federal Council

The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose. In addition, the MedDO was updated to include the extension of transitional timelines for medical devices in line with the EU requirements (Implementing Regulation 2023/607). The required amendments to the MedDO have been approved and will enter into force on 1 November 2023.

Key impacts on new MedDO amendments for medical devices

Manufacturers of devices without an intended medical purpose: 

Implementation of EU 2022/2346, EU 2022/2347, and EU 2023/1194 into the MedDO.

Manufacturers of devices with an intended medical purpose: 

Implementation of EU 2023/607 into MedDO.

Changes implemented:

• • • Implementing Regulation (EU) 2023/607 à Extension of transitional timelines for medical devices.
    • Implementing Regulation (EU) 2023/1194 -> New transition periods for products without intended medical purpose.
    • Commission Implementing Regulation (EU) 2022/2346 -> Common specification for products without intended medical purpose.
    • Commission Implementing Regulation (EU) 2022/2347 -> Reclassification of active products without intended medical purpose

At the time, the changes enter into force on 1 November 2023. Swissmedic will update its website in this regard and publish implementation guides. At the same time, the common specification will be defined in the Federal Gazette, whereby the requirements of MedDO will also apply to product groups without an intended medical purpose.