Switzerland does not have an official approval procedure for medical devices. Market access is based on the Medical Devices Ordinance, abbreviated MepV, whose provisions, adapted to Regulation (EU) 2017/745, came into force on May 26, 2021, and follow the systematics of EU law. Swissmedic is a market surveillance authority, not an approval authority. The crucial difference from the EU lies in the fact that the Agreement on Mutual Recognition of Conformity Assessments was not updated in the medical devices chapter: Switzerland has been considered a third country for medical devices since May 2021, and for in vitro diagnostic medical devices since May 2022.
Consequences of the MRA Chapter’s Discontinuation
Because the European Commission rejected the update of the agreement chapter, mutual recognition, joint market surveillance, and Swissmedic’s access to EUDAMED were discontinued. Switzerland responded with mitigating measures, primarily unilateral recognition: products with EU conformity assessment and CE marking may continue to be placed on the market. Article 25 MepV equates certificates from EU-notified bodies with Swiss ones, provided the procedure meets Swiss requirements and the body is equally qualified. According to Article 13 MepV and Annex 5, the CE mark is also recognized; custom-made devices and investigational products do not bear a conformity mark.
Authorized Representative in Switzerland
Manufacturers with a registered office outside Switzerland must mandate an authorized representative, or CH-REP, according to Article 51 MepV. Their duties largely correspond to Article 11 of Regulation (EU) 2017/745: examination of the declaration of conformity and technical documentation, registration, cooperation in vigilance, and official inquiries. Article 52 MepV additionally requires that the authorized representative permanently has a person responsible for regulatory compliance available and that the technical documentation can be submitted to Swissmedic within seven days. The transitional periods of Article 104a MepV, staggered by risk class, have expired; the name and address must be indicated on the labeling or packaging. Importers have their own disclosure obligations according to Article 53 MepV.
Registration, Deadlines, and Product Information
Economic operators must register with Swissmedic within three months of first placing a device on the market, according to Article 55 MepV; changes must be reported within one week. An identification number, the Swiss Single Registration Number, is assigned. Due to the lack of EUDAMED access, according to the Federal Office of Public Health, a registration obligation for the products themselves will be added from July 2026, with a six-month transitional period. A special requirement concerns language: according to Article 16 MepV, product information includes labeling and instructions for use, is based on Annex I Chapter III of Regulation (EU) 2017/745, and must be drafted in the three official languages: German, French, and Italian. Standardized symbols can replace linguistic statements; for exclusive supply to healthcare professionals, fewer languages or English are possible according to paragraph 3.
Transitional Periods and Planned Opening
The MepV was adapted on November 1, 2023, to the extended EU transitional periods. Higher-risk products may be placed on the market under the specified conditions until December 31, 2027; medium and lower-risk products until December 31, 2028; the sell-off period has been abolished. Additionally, on April 30, 2025, the Federal Council decided, in implementation of Motion 20.3211, that products approved by the US authority may also be placed on the market in the future under certain conditions, such as Swiss data protection, quality management system, and post-market surveillance plan; independent private bodies are to simplify this review. Until the ordinances are adapted, the current law remains unchanged.
Distinction from EU Conformity Assessment and Medicinal Product Authorization
Three distinctions are essential for practical application. First, Swiss recognition does not replace EU conformity assessment but presupposes it; those serving both markets supplement the procedure under Regulation (EU) 2017/745 with Swiss obligations regarding authorized representatives, registration, and language. Second, unlike medicinal products, Swissmedic does not make product-specific authorization decisions; its role lies in market surveillance, vigilance, and authorization of clinical trials. Third, recognition is not reciprocal: a procedure carried out only in Switzerland does not grant access to the EU market. The European basis is presented in the EU MDR 2017/745 entry.
Relevance for clinical trials
Clinical trials with medical devices in Switzerland are governed by the Human Research Act and the Ordinance on Clinical Trials with Medical Devices. Categorization is crucial: Category A applies if the product bears a conformity mark according to Article 13 MepV, is used as intended, and is not prohibited. Such trials only require authorization from the cantonal ethics committee. Category C covers pre-market trials: use deviating from the instructions for use, products not yet CE-marked, and products prohibited in Switzerland. Here, authorizations from Swissmedic and the ethics committee are required.
For multinational studies, this results in a separate timeline, as Switzerland does not participate in the coordinated EU procedure and requires its own submissions. Proof of insurance, investigator site agreements, and trial registration also follow Swiss requirements. Full-service CROs like Mediconomics support sponsors with categorization according to Swiss law, submissions to Swissmedic and ethics committees, coordination of parallel EU and Swiss procedures, and medical writing for study protocols and study documents.
Frequently Asked Questions (FAQ)
Does a CE-marked product require Swiss authorization?
No. Switzerland unilaterally recognizes conformity assessments under EU law and the CE mark. However, an authorized representative, registration with Swissmedic, and product information according to Article 16 MepV are required.
When is an authorized representative necessary?
Always, if the manufacturer has its registered office outside Switzerland. The authorized representative must permanently have access to a person responsible for regulatory compliance and provide the technical documentation within seven days.
Is the ethics committee sufficient for clinical trials?
Only for Category A, i.e., for the intended use of a conformity-marked product. Category C trials additionally require authorization from Swissmedic.
Regulatory References
- Medical Devices Ordinance MepV, SR 812.213, particularly Articles 13, 16, 25, 51 to 55, and 104a
- Regulation (EU) 2017/745 as the basis for recognized conformity assessment
- Human Research Act and Ordinance on Clinical Trials with Medical Devices
- Information from the Federal Office of Public Health on medical device law and mitigating measures
- Federal Council Decision of April 30, 2025, on Motion 20.3211
