New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices
As of 26 May 2021, devices without an intended medical purpose (devices listed in Annex 1 MedDO) have been governed by the Medical Devices Ordinance.
The amendments relating to Implementing Regulations (EU) 2022/2346 and (EU) 2022/2347 issued by the European Commission, establishing the common specifications and classification rules for product groups without an intended medical purpose, were integrated in an equivalent manner into the Swiss Medical Devices Ordinance by resolution of the Federal Council dated 29 September 2023.
Following entry into force of the revised MedDO and the definition of the common specifications for product groups without an intended medical purpose by Swissmedic in the Federal Gazette, the legal requirements for devices without an intended medical purpose will take effect in Switzerland as at 1 November 2023.
This change will affect economic operators (manufacturers, importers, distributors and authorised representatives) and users in the following areas, among others:
What requirements will take effect as at 1 November 2023?
From this date, devices without an intended medical purpose must fulfil the common specifications and relevant general safety and performance requirements of the Medical Devices Ordinance (“MedDO”). Making devices available on the Swiss market is now subject to the MedDO.
However, transitional periods have been provided to allow economic operators (manufacturers, importers, distributors and authorised representatives) to adapt to the new requirements and ensure devices are placed on the market in compliance with the MedDO.
Swissmedic’s responsibility in market surveillance
Swissmedic is responsible for market surveillance of devices that are subject to the MedDO, i.e. devices without an intended medical purpose that have certification under the former Council Directive 93/42 EEC dated 14 June 1993 concerning medical devices or the current Regulation (EU) 2017/745 of the European Parliament and Council dated 5 April 2017 regarding medical devices and that are being placed on the market in Switzerland for the first time under the new MedDO provisions with effect from 1 May 2024.
Swissmedic is not responsible for market surveillance of products that are marketed in Switzerland under the old sector-specific legislation.
Therefore, Swissmedic is responsible for surveillance with regard to placement of medical devices and of devices without an intended medical purpose on the market that are subject to the MedDO, meaning that as a rule, Swissmedic is not responsible for the use of these devices or for the users.
Why this new regulation?
The Federal Council opted to make certain devices without an intended medical purpose that are comparable to medical devices in terms of function and risk profile subject to the Therapeutic Products Act (TPA).
The revisions to the requirements for placing these devices on the market and post-market surveillance as at 1 November 2023 are meant to ensure that the devices, when used as intended, are effective and do not endanger the health of the users, consumers and third parties.