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The federalist structure of the Swiss health system

Since 1996, Switzerland ensures access to healthcare to every resident through a system of mandatory health insurance (MHI). The Swiss health system is highly decentralised. The federal government defines the regulatory framework for the public health system and manages the mandatory health insurance, the fight against communicable diseases, medically assisted reproduction and transplants. Cantonal governments are responsible for the provision of healthcare and for the implementation of federal policies.

Financial flows are split between different government levels and social insurance schemes. Resources are mostly collected through taxes and MHI premiums, with a substantial part allocated to the various social insurance schemes, to subsidise MHI premiums for lower-income households.

Switzerland is advancing digitalisation of its healthcare system

In international comparison, the digitalisation of the Swiss healthcare system remains fragmented and is not harmonised, which has become increasingly apparent during the Covid 19 pandemic. For example, already collected data needs to be re-entered most of the time and can rarely be used for different purposes. Switzerland wants to implement the "once-only principle", which allows patients to provide their data only once, while permitting multiple uses. To achieve this, the country is endeavouring to coordinate digital processes transparently and ensure that interfaces work smoothly, in particular by putting in place a joint strategy involving all stakeholders (healthcare professionals, eHealth innovators, etc.).

The government’s current "DigiSanté" programme aims to make up for Switzerland's lag in digitalising the healthcare system between 2025 and 2034. One of the main goals of the program is to coordinate and align all partners within the scope of their responsibilities to pursue their shared ambition. In parallel, the electronic patient record is being further developed as one of the central pillars of the digitisation of healthcare services, with aiming at a broad establishment among inhabitants and healthcare providers.

How to access the Swiss digital health market?

Switzerland has comprehensively revised its medical devices legislation in line with the EU Regulations on medical devices (MDR and IVDR).

Applications or software considered to be medical devices must obtain European CE certification or the Swiss medical device label to be legally placed on the Swiss market.

The procedure for obtaining the Swiss label is virtually identical to that used in the EU. For example, the criteria for classifying medical devices are the same as those used in the EU. However, obtaining the Swiss label involves some additional specificities, such as:

The requirement for foreign manufacturers to appoint an authorised representative in Switzerland ("CH-REP").
The compulsory registration of economic operators with Swissmedic to be legally placed on the Swiss market.

As for reimbursement by health insurance companies, the manufacturer needs to be able to prove that his device is effective, fit for purpose and cost efficient. By following the procedure Reimbursement by health insurance companies.

Sources regarding qualification and classification of medical devices

The definitions of medical devices, in vitro medical devices and their accessories are specified in Art. 3 of the Medical Devices Ordinance (MedDO) and Art. 3 of the Ordinance on In Vitro Diagnostic Medical devices (IvDO).

Products are divided into classes I, IIa, IIb and III according to Art. 15 MedDO or A, B, C and D according to Art. 14 IvDO, depending on their intended purpose and the associated risks.

It is the responsibility of the manufacturer to correctly classify his devices. Art. 15 MedDO and Art. 14 IvDO specifies that for classification purposes, Annex VIII of EU-MDR and EU-IVDR apply, respectively.