Since 1 July 2026, a new obligation has been turning heads across the industry: every medical device placed on the Swiss market must be registered in the swissdamed database – regardless of risk class or product type. Manufacturers who have not yet completed this registration have until 31 December 2026 to do so. After that date, only registered products may be marketed in Switzerland.Source (only available in German): Swissmedic, Art. 108 Abs. 2 MepV / Art. 90 Abs. 2 IvDV)
This deadline is a good reason to take a fresh look at the Swiss market as a whole. Many manufacturers already well established in Germany and the EU have long dismissed Switzerland as "too small" or "too complicated". Neither view holds up to scrutiny.
A Market Growing Faster Than the Economy as a Whole
According to the 2024 industry study by Swiss Medtech and the Helbling Group, revenue in the Swiss medtech sector rose from CHF 20.8 billion (2021) to CHF 23.4 billion (2023) – growth that was twice as high as Switzerland's nominal GDP over the same period. In 2023, the sector employed around 71,700 people across roughly 1,400 companies, 95 per cent of which have fewer than 250 staff – a strongly SME-driven market in which European manufacturers of comparable size can compete on equal footing. (Source (only available in German): Swiss Medtech / Helbling Gruppe, Medtech-Branchenstudie 2024)
Demand-side figures reinforce this potential. According to the Swiss Federal Statistical Office, Switzerland's healthcare costs rose to CHF 97.2 billion in 2024 – 11.4 per cent of GDP, equivalent to CHF 899 per resident per month. (Source (only available in German): BFS – Statistik der Kosten und der Finanzierung des Gesundheitswesens, 2024) Of this, around CHF 15.6 billion was spent on healthcare goods alone. Switzerland is also, according to Swiss Medtech, one of the countries with the highest number of medtech employees per capita in Europe – a strong indicator of an environment that welcomes innovation and where investment in healthcare provision enjoys broad political support. (Source (only available in German): Swiss Medtech / Helbling Gruppe, Medtech-Branchenstudie 2024).
There is also a factor many manufacturers overlook: Germany is the Swiss medtech industry's most important EU trading partner. (Source (only available in German): Swiss Medtech / Helbling Gruppe, Medtech-Branchenstudie 2024) Manufacturers already familiar with German authorities, payers and distribution structures bring with them a meaningful head start in understanding the Swiss market.
Why "Simply Shipping with a CE Mark" Does Not Work
Since the Mutual Recognition Agreement (MRA) with the EU lapsed in May 2021 without an update, Switzerland has no longer been automatically aligned with the EU single market. (Source (only available in German): Swissmedic, Merkblatt „Pflichten Wirtschaftsakteure CH“). The Swiss Medical Devices Ordinance (MepV) follows the content of the MDR closely, but it requires additional, independent steps not found anywhere in the EU – and this applies to products of every risk class:
- A Swiss Authorised Representative (CH-REP). Manufacturers without a registered office in Switzerland or Liechtenstein must appoint a CH-REP. The relevant transitional periods have already expired. (Source (only available in German): Swissmedic, Merkblatt „Pflichten Wirtschaftsakteure CH“, Art. 104a MepV). Any manufacturer active on the Swiss market today without a CH-REP is not operating within an ongoing transitional period – they are operating outside the current rules.
- Registration as an economic operator with a CHRN. Under Art. 55 MepV, the CH-REP and, where applicable, a Swiss importer each require their own Swiss registration number.
- Product registration in swissdamedmandatory since 1 July 2026, with a grace period until the end of 2026 – as outlined above. (Source (only available in German): Swissmedic, Art. 108 Abs. 2 MepV / Art. 90 Abs. 2 IvDV).
- A PRRC for the CH-REP itself. Under Art. 52 MepV, the Swiss Authorised Representative must also appoint a Person Responsible for Regulatory Compliance – regardless of whether the manufacturer has already appointed its own PRRC under the MDR .
These obligations apply irrespective of product type or company size. What tends to differ is how well an organisation is already prepared for them: manufacturers with an established regulatory affairs team can usually fold Swiss requirements into existing processes fairly quickly. Manufacturers with leaner structures, on the other hand, more often underestimate that Switzerland operates its own registers, its own deadlines and its own regulatory logic, which does not simply mirror the MDR.
What Makes Market Entry Easier in Practice
For the Swiss market, we work closely with our partners at Albo-Healthcare . Together, we take on the role of Swiss Authorised Representative (CH-REP), support the CHRN registration process, assist with product registration in swissdamed, and keep an eye on ongoing reporting and vigilance obligations towards Swissmedic.
For clients who already work with us in Germany or at EU level – for instance on MDR documentation, PRRC appointment or German Medical Technical Aids-Register, Swiss market access can usually be added without major additional effort: much of the required documentation (technical documentation, declaration of conformity, labelling) already exists and simply needs to be supplemented and correctly assigned for Switzerland.
The Next Step
If you would like to understand where your company currently stands with regard to the Swiss market – whether the CH-REP obligation is already met for your product class, whether a CHRN is in place, and what still needs to be done for swissdamed registration before the end of 2026, talk to us. Together with our partners at Albo-Healthcare we will assess your status and show you which steps are actually necessary for your products.
(1 Rating(s), average: 5.00 out of 5)
Loading...
