Top Errors When Importing Medical Devices into Switzerland

In regard to importing medical devices into Switzerland under the former Mutual Recognition Agreement (MRA) with the European Union – based on the EU medical device directives – Swissmedic’s regulatory oversight was largely aligned with that of other major EU regulatory authorities. However, following the implementation of its independent regulatory framework under the Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Swissmedic has adopted a more proactive approach to market surveillance and compliance enforcement.

Errors Made by Manufactures Importing Medical Devices into Switzerland

This article outlines three common pitfalls encountered by medical device manufacturers when importing devices into Switzerland. 

#1: Assuming “Light” Regulatory Oversight by Swissmedic 

With CE marking continuing to facilitate the placement of medical devices on the Swiss market, Swissmedic remians acutely aware of the regulatory challenges that prompted the development of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In response, Swissmedic has adopted a more proactive regulatory stance, including the implementation of trageted focus campaigns.  

One such campaign, that includes importing medical devices into Switzerland we previously highlighted here, involved a comprehensive review of post-market surveillance (PMS) practices for 30 legacy devices classified as risk class IIa and above. Building on this initiative, in April 2025 Swissmedic announced a series of targeted inspections for medical devices importing into Switzerland, aimed at assessing compliance with the obligations set forth in the MedDO / IvDO. These inspections will focus on several key areas:  

• Verification of formal product conformity prior to placing devices on the Swiss market, including adherance to transitional provisions; 

• Compliance with the required device storage and transport conditions; 

• Effective cooperation with regulatory authorities and economic operators in the event of complaints, incidents, and field safety correction actions (FSCA). 

Given that many Swiss importers also act as authorized representatives for non-Swiss manufacturers, Swissmedic may additionally evaluate the completeness and accuracy of technical documentation maintained on file. This includes PMS documentation for self-certified devices, particularly in light of previously identified deficiencies in PMS records for higher-risk devices. 

#2: Mismanagement of EU Registrations / Notifications 

The majority of medical devices are imported into Switzerland from European Union member states– particularly those bordering Switzerland– as manufacturers continue to leverage CE marking for market access.  

Swiss Customs authorities are empowered to inspect goods entering the Swiss market at any time. Given that device registration in Swissdamed will not become mandatory until 2026, Customs officials may instead verify the EU regulatory status of CE-marked devices. This includes confirming that the specific device models or variants are appropriately notified or registered either in the EU member state of export or in EUDAMED, noting that EUDAMED registration is also not yet mandatory. 

If manufacturers have not appropriately maintained their EU notifications / registrations, and Swiss Customs agents identify discrepancies, this may result in delays in customs clearance. In cases where  non-compliant devices have already been placed on the Swiss market, additional regulatory actions may be initiated.  

#3: Non-compliant Labeling 

Manufacturers should not assume that compliance with MDR / IVDR labeling requirements alone is sufficient for placing devices on the Swiss market. While both the MedDO / IvDO do incorporate many of the MDR / IVDR labeling content requirements, they also impose additional, Switzerland-specific requirements, including: 

• Identification of the Swiss authorized representative;  

• Identification of the Swiss importer; 

• Provision of product information in Switzerland’s’  three official languages: French, German, and Italian; 

• Clear labeling of products that are not, or not yet, authorized as medical devices but could be mistaken for such; 

• Specific labeling for devices intended solely for demonstration and presentation purposes; 

• Prohibition of misleading or contradictory information regarding the device’s intended purpose, safety and performance. 

Although providing product information in fewer than the three official Swiss languages is permitted under strictly defined conditions, manufacturers must be prepared to supply the information in any of the official languages—German, French, or Italian—upon request. Additionally, it should be noted that the new EU eIFU Regulation (EU) 2025/1234 has not been implemented in Switzerland. Therefore, manufacturers providing product information in electronic format must ensure their approach complies with Swiss regulatory requirements, which remain aligned with the earlier EU Regulation (EU) No 207/2012. 

Learn More About the Importing Medical Devices into Switzerland with MedEnvoy 

This article provides an overview of some of the common pitfalls manufacturers make when importing medical devices into Switzerland. MedEnvoy’s regulatory experts are available to support manufacturers in navigating Swiss regulatory requirements, more information can be found here. In addition, MedEnvoy offers comprehensive services, including serving as a Swiss authorized representative and importer for medical device manufacturers seeking to enter the Swiss market.