SWISSDAMED: Switzerland’s Medical Device Database

Introduction

Following the termination of the Mutual Recognition Agreement (MRA) between Switzerland and the EU in May 2021, Switzerland had to adapt its regulatory framework to ensure safety standards equivalent to those of the EU. In this context, Swissmedic, the Swiss Agency for Therapeutic Products, launched Swissdamed: a national database dedicated to medical devices and in vitro diagnostic devices.

Swissdamed (Swiss Database on Medical Devices) is a centralized public platform designed to improve the traceability of medical devices and enhance transparency for healthcare professionals and the general public.

Objectives and Scope

Swissdamed aims to:

• Centralize information on medical devices and economic operators (manufacturers, authorized representatives, importers).
• Provide public access to this data to improve transparency.
• Facilitate market surveillance and incident management.
• Ensure regulatory equivalence with the European Union.

The database is structured to reflect the requirements of the Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices Ordinance (IvDO), while drawing inspiration from the structure of EUDAMED, the European database.

Modular Architecture

Swissdamed is built around two main modules:

1. The “Actors” module

Launched on August 6, 2024, this module enables the registration of economic operators based in Switzerland or Liechtenstein. This includes:

• Swiss or Liechtenstein manufacturers.
• Swiss authorized representatives for foreign manufacturers.
• Importers established in Switzerland or Liechtenstein.

Registration is mandatory in accordance with Article 55 of MedDO and Article 48 of IvDO.

2. The “Devices” module

Scheduled for July 1, 2026, this module will allow the registration of medical devices, systems, and procedure packs. A transitional period is planned until December 31, 2026. However, in the event of a serious incident or field safety corrective action, immediate registration will be required.

Devices must be registered before being placed on the Swiss market. Registration will be done by uploading XML files, or a M2M interface.

Progressive Rollout

The implementation of Swissdamed is taking place in three phases:

1. Phase 1 (2024): registration of economic operators via the Actors module.
2. Phase 2 (2026): registration of medical devices via the Devices module.
3. Phase 3 (post-2026): addition of complementary features to existing modules.

This progressive approach allows market participants to adapt to new requirements while ensuring a controlled system rollout.

Technical Integration and Challenges

One of the major challenges of Swissdamed lies in its technical integration. To date, Swissmedic has not yet published the technical specifications for the M2M (machine-to-machine) interface.

Pending this interface, Swissmedic recommends using XML files exported from EUDAMED for device registration. This method, while functional, is considered complex and not very robust by some industry players, particularly due to the technical burden it places on manufacturers.

Comparison with EUDAMED

Swissdamed is strongly inspired by EUDAMED, the European database, but with specific features tailored to the Swiss context. Here is a comparative overview: 

	Swissdamed	EUDAMED
Geographic Scope	Switzerland and Liechtenstein	European Union
Modules	Actors, Devices (upcoming)	Actors, UDI/Devices, NB & Certificates, Vigilance and Post-Market Surveillance (upcoming), Clinical Investigations and Performance Studies (in development), Market Surveillance
M2M Interface	In development	Available for some modules
Public Access	Yes, via a web interface	Yes, for certain modules

Swissdamed thus allows some compatibility with European systems while maintaining regulatory autonomy suited to the Swiss legal framework.

Outlook and Challenges

1. Regulatory Harmonization

Swissdamed helps maintain regulatory equivalence between Switzerland and the European Union, despite the end of the MRA. This is essential to ensure access of Swiss devices to the European market and vice versa.

The latest example of harmonization is of the EU requirements for the electronic provision of instructions for use (eIFU) for medical devices, in force since 16 July 2025, and applicable in Switzerland with immediate effect and without additional amendments to MedDO.

Reminder: According to the Implementing Regulation (EU) 2021/2226, when registering devices, manufacturers must provide to EUDAMED’s Unique Device Identifier (UDI) database the internet address under which the eIFUs are accessible.

2. Transparency and Safety

By making data on devices and operators accessible, Swissdamed enhances market transparency and facilitates the detection of incidents or non-compliance.

3. Collaboration with Industry Stakeholders

Swissmedic plans to collaborate with professional associations such as Swiss Medtech and ASID to organize pilot phases and test the database’s functionalities.

Conclusion

Swissdamed represents a strategic advancement for Switzerland’s regulatory sovereignty in the field of medical devices.

By aligning with European standards while developing a national solution, Swissmedic provides market players with a robust, scalable tool for market transparency and thus facilitated market surveillance and incident management.