Manufacturers and other economic operators active in the Swiss medical device market must comply with many regulations. Swissmedic, the Swiss supervisory authority for therapeutic products, is responsible for enforcing these regulations and conducting administrative procedures in case of violations. But how exactly does such a procedure work, and what should companies know to act correctly and in good time? This article provides an overview of the procedure and the unique features of such procedures, especially for non-lawyers.

Background

In Switzerland, medical devices are strictly regulated by law to ensure safety and efficacy for patients. Swiss medical device legislation is modelled on the EU Medical Device Regulation (MDR). Despite this alignment of content, responsibility for implementation and enforcement in Switzerland lies with the national authorities, particularly Swissmedic. In the EU, the national regulatory authorities of the member states are responsible for enforcement.

Swissmedic, the Swiss authority responsible for authorising and supervising therapeutic products, ensures that only compliant and safe products are placed on the market. To this end, Swissmedic monitors compliance with the relevant provisions of the Therapeutic Products Act (TPA, SR 812.21) and associated ordinances.

Initiation of administrative procedures

Administrative procedures generally begin when Swissmedic becomes aware of a possible violation of the applicable law. Such a proceeding may be initiated based on a report from a third party (e.g., competitors, employees, foreign authorities), an official priority action, or an inspection by Swissmedic.

Course of procedures

Administrative procedures are subject to specific legal requirements set out in the Administrative Procedure Act (APA, SR 172.021). The procedure begins when Swissmedic opens it, usually in the form of a written decision explaining the facts of the case and the suspected violations. The companies concerned are typically given a period to comment. This is not just a formality but an opportunity to present their point of view and, if necessary, to submit evidence to refute the allegations.

Swissmedic can request additional information during the procedure or conduct on-site inspections. How a company cooperates with the authority during this phase is crucial. It is essential that deadlines are met and that all requested information is provided completely and accurately to ensure that the procedure runs smoothly.

Rights and obligations of the parties involved

Manufacturers or distributors of medical devices subject to administrative procedures have certain rights and obligations throughout the process. A central right is the right to be heard, which ensures that affected parties are listened to before making an official decision. This means that companies have the right to comment fully on the allegations made and present evidence to support their position. It is advisable to seek the assistance of legal counsel or technical experts to ensure a precise and well-reasoned response.

In addition, the parties involved have the right to inspect the procedural documents. This disclosure enables companies to understand the status of the investigation and the basis of the decision, which in turn helps them to make well-founded statements or prepare possible appeals.

At the same time, the companies concerned are obliged to fulfil certain obligations. Companies are obliged to provide Swissmedic with all relevant information required to clarify the facts of the case. This includes, in particular, technical documentation, evidence of compliance with regulatory requirements and risk assessment reports. The complete and timely submission of this information is not just a requirement but a proactive step that is crucial in order to avoid delays in the procedure. If information is provided incompletely or late, this can not only have a negative impact on the course of the procedure but may also lead to additional sanctions.

Conclusion

Administrative procedures by Swissmedic can have far-reaching consequences for economic operators of medical devices. The best precaution is to comply with the applicable requirements consistently. This proactive approach can significantly reduce the risk of negative outcomes. Should a procedure be initiated, it is advisable to consult experts as early as possible. Experts can support you in correctly assessing the allegations, submitting timely and precise statements, submitting all required documents in full and following the regulations. Their support, coupled with your compliance, can significantly speed up the process and protect the company from long-term consequences.

Bernhard Bichsel
Co-CEO, ISS AG

References:
Professional Support: https://www.iss-ag.ch/en/services/corporate-services/professional-support-for-administrative-proceedings 
Federal Act on Administrative Procedure: https://www.fedlex.admin.ch/eli/cc/1969/737_757_755/en
Swissmedic – Market Surveillance: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices.html