Swissmedic

Discussion

Swissmedic emphasized its role as Switzerland’s supervisory authority for medicines and medical devices. To be placed on the Swiss market, products must first be classified by the manufacturer (e.g., medicine, medical device, cosmetic) and must comply with the relevant legislation. For medical devices like ours, this involves a conformity assessment procedure as defined in the Medical Devices Ordinance (MepV; SR 812.213) and the In Vitro Diagnostics Ordinance (IvDV; SR 812.219).

Unlike medicines, medical devices are not directly approved by Swissmedic. Instead, conformity assessments—depending on the device’s risk class—are conducted by notified bodies. Swissmedic, in turn, is responsible for post-market surveillance. They also made it clear that, as a regulatory authority, they cannot provide detailed consulting on development, classification, or certification processes.

Regarding self-tests, Swissmedic highlighted strict legal restrictions under Art. 61 IvDV:

“The dispensing of products for the detection of communicable human diseases to the public is prohibited. Swissmedic may grant exceptions in the interest of public health.”

“The dispensing of products for the detection of communicable human diseases to the public is prohibited. Swissmedic may grant exceptions in the interest of public health.”

Currently, such exceptions exist only for HIV and SARS-CoV-2 self-tests. In addition, diagnostic products fall under the Epidemics Act (EpG), which requires that tests for communicable diseases are generally performed only in authorized microbiological laboratories. This means that the legal barriers go well beyond medical device regulation. Swissmedic also underlined that these requirements are set by lawmakers, not by Swissmedic itself. The reasoning behind such requirements is usually explained in policy messages or explanatory reports issued by the Federal Council (e.g., through the Federal Office of Public Health, BAG).

Main Takeaways

• Approval process: Unlike medicines, medical devices are not directly approved by Swissmedic; instead, notified bodies conduct conformity assessments based on the device’s risk class.
• Restrictions on self-tests: Under Art. 61 IvDV, products for detecting communicable diseases cannot be sold directly to the public, except for cases where Swissmedic grants specific exemptions (currently only for HIV and SARS-CoV-2 self-tests).
• Additional legal barriers: Diagnostic products also fall under the Epidemics Act (EpG), which generally limits testing for communicable diseases to authorized laboratories.
• Product classification: Before market entry, manufacturers must classify their products (e.g., medicine, medical device, cosmetic) and comply with the corresponding legal framework.
• Medical device requirements: Devices like ours must undergo a conformity assessment procedure as outlined in the Medical Devices Ordinance (MepV; SR 812.213) and the In Vitro Diagnostics Ordinance (IvDV; SR 812.219).
• Legislative authority: These regulations are set by lawmakers, not Swissmedic, and are explained in official policy communications or explanatory reports from the Federal Council or the Federal Office of Public Health (BAG).

Integration

We integrated these insights by:

• We contacted the BAG (Federal Office of Public Health) for further clarification.
• We shifted our development focus toward a point-of-care (POC) syphilis test designed for clinical use, rather than direct-to-consumer self-testing.