The Federal Council aims to safeguard the supply of medical devices

Bern, 29.03.2023 - The Federal Council intends to grant an extended period for the certification of medical devices, in line with the extension of the equivalent European regulation. This move aims to safeguard the supply of medical devices in Switzerland. In its session of 29 March 2023, it was informed of the steps that the Federal Department of Home Affairs is taking towards incorporating the EU Regulation of 15 March 2023. This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).

In 2001, Switzerland introduced a regulation equivalent to that of the European Union (EU) in the area of medical devices, and it has since brought its legal provisions in line with those of the EU. The aim of this is to ensure patient safety as well as to safeguard the supply of medical devices. In the wake of a number of incidents and scandals involving medical devices, the EU and Switzerland have adopted a new legislatory framework which aims to improve the safety of medical devices.

The transitional period from the old EU directives to the new regulation specifies that certificates of conformity for medical devices issued under the old legislation will remain valid until 26 May 2024 at the latest. However, it has come to light that this period is not long enough to ensure that all devices are certified in line with the new legislation.

Extension of the transitional period under certain conditions

In order to minimise the risk of shortages of medical devices and the health-related consequences this could entail, the European Parliament and the Council of the European Union have thus decided to extend the transitional period under certain conditions.

The Federal Council is also aware of the European Regulation of 1 December 2022 laying down rules for groups of products without an intended medical purpose. These products will be subject to the legislation applicable to medical devices. This primarily concerns cosmetic treatment products such as devices for laser hair removal or fat reduction, as well as to products intended to enhance cognitive function such as non-invasive brain stimulation equipment.

In order to maintain equivalence with the EU provisions and reduce the potential impact on supply in Switzerland, the Federal Council intends to incorporate the EU provisions and thus to adopt the necessary modifications to the MedDO and IvDO in autumn 2023.

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