In recent years, Switzerland revised its legislation on medical devices. Since May 26 2021, Switzerland and the European Union haven't reached an institutional agreement on medical device regulations. As a result, Switzerland is officially considered a “Third Country” for Europe.
While Swiss regulations are now quite similar to those of the European Union, they have specificities you'll need to consider if you want your products to be marketed and placed in the country.
Switzerland Medical Device Regulations
Switzerland Medical Device Regulations and competent Swiss authorities
Swissmedic, the Swiss authority responsible for the authorization and supervision of therapeutic products, regulates medical devices in Switzerland. Its role is to authorize medicinal products, give licenses for manufacturing and wholesale, inspect operators, monitor the market, proceed with prosecutions, establish standards, being involved in clinical trials and laboratory tests.
Medical devices in Switzerland are subject to regulation under:
- the Therapeutic Products Act (TPA, SR 812.21),
- the Medical Devices Ordinance (MedDO, SR 812.213),
- the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219),
- the Human Research Act (HRA, SR 813.30), and
- the Ordinance on Clinical Trials with Medical Devices (CTO-MedD, SR 810.306).
To date, the content of the legislation is harmonized with that of the European Union (EU).
Medical device classification in Swiss law
The European Union has taken significant steps to enhance the quality and safety of medical devices by imposing stricter requirements. The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are now fully applicable since May 26, 2021, and May 26, 2022, respectively.
Switzerland, recognizing the importance of aligning with European law, has promptly adjusted its legislation to reflect these developments. The MDR regulations have been integrated into the Therapeutic Products Act (TPA), the Human Research Act (HRA), the Medical Devices Ordinance (MedDO), and the new ClinO-MD, which have been in effect since May 26, 2021. Similarly, the regulations of the IVDR have been incorporated into the TPA, HRA, In Vitro Diagnostic Medical Devices Ordinance (IvDO), and ClinO-MD, which have been enforceable since May 26, 2022.
This harmonization of Swiss law with European regulations demonstrates Switzerland's commitment to upholding the quality and safety of medical devices and its openness to doing business with international companies, ultimately benefiting patients and healthcare professionals.
In terms of Swiss medical device classifications, they are the same as those of the EU. For example, the Medical Devices Ordinance (MedDO) declares: "Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-MDR39, taking account of the implementing acts of the European Commission listed in Annex 5a."
Recognition of the CE mark
To address the challenges resulting from the absence of an updated agreement with the European Union, the Federal Council in Switzerland has implemented various measures to mitigate the impact. These measures are specifically designed to protect the availability of safe medical devices in Switzerland and to ensure effective market surveillance.
One notable measure is the unilateral recognition of medical devices that have obtained the EU conformity assessment, indicated by the CE marking. This recognition maintains the supply of high-quality medical devices and upholds safety standards in Switzerland.
Significant differences: Placing a Medical Device on the Swiss Market
Placing a medical device on the Swiss market
As a consequence of the EU and Switzerland not reaching a complete mutual agreement, the mutual possibility for European and Swiss manufacturers not to appoint an authorized representative on the territory of the other contracting party no longer applies between Switzerland and the EU.
As a foreign manufacturer, you can no longer use your CE-Rep to place your products on the Swiss market. You must appoint a CH-Rep based in Switzerland to do so. If you want to learn more about the role of a CH-Rep, you can read our dedicated article on this page.
In the revised Swiss regulations, Swissmedic has identified 5 operators who play a role in registering, importing, placing on the market, and distributing a medical device in Switzerland. An entity can assume different roles depending on each particular case.
The 5 main operators defined by the Swiss medical device regulation are:
- The Manufacturer
- The Swiss-authorized representative (CH-REP)
- The Importer
- The Distributor
- The Healthcare institution or professional (i.e., hospital/doctor)
If you are now reading these lines to prepare your market entry in the Swiss medical device market, we recommend reading our article on the obligations of your medical device distributor in Switzerland.
More information on the obligations of economic operators in Switzerland: Medical devices (swissmedic.ch)
Switzerland Medical Device Regulations: Registration, reporting, and monitoring
Another point that will differ is that you no longer deal with the European Union authorities for anything related to the Swiss market.
You will have to deal with Swissmedic directly in all the procedures. Indeed, the European Union excluded Switzerland from the common market surveillance system, and Swissmedic's access to the European medical devices database was revoked.
As a result, you, the foreign manufacturer (and your partners in Switzerland, the economic operators), must complete the mandatory registrations (companies, persons, and products) with Swissmedic. You will also need to report serious incidents to Swissmedic and do post-market surveillance in cooperation with them.
More information on the obligations of economic operators in Switzerland: Medical devices (swissmedic.ch)
Although we are not a company with expertise in CE mark, CH-Rep, and Medical Device registration in Switzerland, we have partner companies in our network that we can introduce you to. Feel free to contact us for more details.
If you are looking to identify a Swiss medical device distributor, our company, Masson International, helps yearly dozens of foreign companies find and start a collaboration with a Swiss distributor. You can find more information on our Distributor search service page or in the article "How to Find a Medical Distributor in Switzerland".
The information in this article and website is provided solely for general interest. Please note that the information provided may not be up-to-date with current legal developments and should not be considered as legal advice or expertise.
We cannot guarantee or vouch for the completeness, accuracy, reliability, suitability, or availability of the information provided on the website and this article.
Therefore, reliance on such information is strictly at your own risk. For more specific, comprehensive, and up-to-date information, you should seek the opinion of legal counsel and professionals in medical device registration. In no event will we be liable for any loss or damage, including, without limitation, indirect or consequential loss or damage arising out of, or in connection with, the use of this article and website.
