Swissmedic Requirements: Device Notifications for Manufacturers

Swissmedic, which is affiliated with the Swiss Federal Department of Home Affairs, is responsible for the regulatory oversight of therapeutic products in Switzerland, including medicines and medical devices which includes regulating device notifications for manufacturers. Since the EU declared the mutual recognition agreement (MRA) for medical devices no longer applicable following a breakdown in negotiations with the Swiss government in 2021, manufacturers intending to place their devices on the Swiss market or put them into service in Switzerland have had to comply with a standalone medical device regulatory framework established under the Medical Devices Ordinance (MedDO) (and under the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) for in vitro diagnostic medical devices (IVDs)). 

While the MedDO and IvDO each leverage elements of the EU MDR and IVDR, respectively, there are several Swiss-specific compliance requirements that manufacturers should be aware of. Among these requirements is device notification, which is mandatory for several types of devices, including IVDs, custom-made devices, and systems or procedure packs. As Swissmedic is no longer a Competent Authority with access to EUDAMED, it has developed its own similar database, known as ‘swissdamed.’ Similar to EUDAMED, swissdamed is being rolled out in several phases, with mandatory registration of economic operators required since August 2024 and medical device/IVD notification becoming mandatory from July 2026. 

How to Perform Medical Device Notifications Under Swissmedic

1. Who to Select as the Swiss Authorized Representative?

All medical device manufacturers located outside Switzerland intending to place their devices on the Swiss market or put them into service in Switzerland must assign a Swiss Authorized Representative (CH-REP), to serve as their regulatory representative. This entity acts on behalf of the manufacturer in a similar manner to the EU Authorized Representative (EC-REP) as signed by manufacturers located outside the EU and the European Economic Area (EEA) European Free Trade Association (EFTA) States, including registering devices with Swissmedic. 

While there are no restrictions preventing foreign manufacturers from assigning an importer or distributor as their CH-REP, given the regulatory responsibilities incumbent upon the CH-REP (including device registration), it is recommended that an entity independent of the Swiss distributor be assigned to this role. This approach reduces the potential regulatory impact of changes in distributors, particularly since CH-REP information must accompany devices. 

2. How are Medical Devices Classified in Switzerland?

Under the MedDO and IvDO, the same device classifications established under the EU MDR and IVDR are used. 

3. Can Marketing Authorizations in Other Countries be Leveraged?

Yes. Under the MedDO and IvDO, CE-marked devices can be placed on the Swiss market or put into service in Switzerland; however, there are restrictions on so-called “legacy devices” that are CE-marked under the former EU MDD, AIMDD, and IVDD but continue to be placed on the EU market under the transitional provisions of the EU MDR/IVDR. 

Swissmedic has flagged “legacy devices” as an area of regulatory concern and has indicated to CH-REPs that it expects these economic operators to review “legacy devices” as part of their verification and due diligence obligations. Specifically, this includes manufacturers providing the following to their CH-REP: 

• • A self-declaration by the manufacturer confirming that the conditions for placing devices that comply with the old legislation on the market are met (refer to the template from MedTech Europe) 
  • A confirmation letter issued by the designated/notified body stating that a written agreement has been signed before September 26, 2024 (see Team-NB template) 

4. What Information and Cost is Necessary for Swissmedic Device Notifications?

Firstly, it is important to note that notification is not mandatory for all devices, with only the following devices currently subject to this requirement: 

• • Class I medical devices manufactured by Swiss manufacturers (CH-REPs are not required to notify such devices for manufacturers located outside Switzerland but must ensure that these devices comply with MedDO requirements) 
  • IVDs manufactured by Swiss manufacturers (CH-REPs are not required to notify such devices for manufacturers located outside Switzerland but must ensure that these devices comply with IvDO requirements) 
  • Systems/Procedure Packs assembled by assemblers located in Switzerland (CH-REPs are not required to notify such devices for assemblers located outside Switzerland but must ensure that these devices comply with MedDO requirements) 
  • Custom-made devices

Registration of manufacturers/assemblers located outside of Switzerland is not required for device notifications under Swissmedic and Swissmedica have publicly made the respective notification forms available for those devices requiring notification. These forms are available here on the Swissmedic website. 

All device notifications are subject to a CHF 300 fee, with an additional administrative fee of CHF 200 per hour applicable in specific cases (e.g., incomplete or inappropriate documentation, late withdrawal of a notification application, request for information, corrections). 

5. What are the Timelines for Swissmedic Device Notifications?

The time for Swissmedic to process notification applications is approximately one month from receipt, assuming that no questions are raised by the agency and the application contains all necessary information and documentation. 

However, it is important to note that the statutory notification obligation is fulfilled upon submission of the notification application to Swissmedic. 

6. What Types of Changes Require a Notification of Variation to Swissmedic?

The following types of changes require a notification of variation to Swissmedic: 

It is important for manufacturers to note that device notification with Swissmedic does not confer any endorsement, accreditation, certification, or approval by Swissmedic. Therefore, manufacturers are not permitted to make any such claims, and it is prohibited to use any Swissmedic logos in marketing materials, device packaging, instructions for use, or any other documentation. 

Learn More about Swissmedic with MedEnvoy 

MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the latest requirements including Swissmedic Device Notifications, how to obtain conformity assessment and how notify medical devices in Switzerland. Furthermore, MedEnvoy has offices in Switzerland providing both CH-REP and Swiss Importer services, for more information, click here. Please reach out should you need assistance by clicking here and for information about our regulatory experts click here. 

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