Switzerland Medical Device Registration

Navigating Medical Device Registration & Post-Market Surveillance in Switzerland

Overview on Medical Device Registration

Medical devices placed on the Swiss market must comply with the Swiss Medical Devices Ordinance (MedDO) or the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO), which are largely aligned with the EU Medical Device Regulation (EU MDR 2017/745) and EU In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).

Following the lapse of the Mutual Recognition Agreement (MRA) between Switzerland and the European Union for medical devices, manufacturers established outside Switzerland are generally considered third-country manufacturers and must comply with additional Swiss regulatory requirements, including the appointment of a Swiss Authorised Representative (CH-REP), where applicable.

Medical devices undergo conformity assessment according to their risk classification, and most devices require CE marking before being placed on the Swiss market.

Swissmedic does not issue marketing authorisations for medical devices but is responsible for market surveillance, vigilance, enforcement activities, and overseeing compliance with Swiss medical device legislation.

Since 2026, device registration requirements have been progressively implemented through the swissdamed database.

Regulatory Authority

Swissmedic

Swissmedic is the Swiss authority responsible for authorizing and supervising therapeutic products, based on the Law on Therapeutic Products. As a Federal public law institution, it is autonomous and has its own budget. It is primarily funded by fees and payments from the Confederation.

Swissmedic is attached to the Federal Department of Home Affairs, with the Agency Council as its strategic decision-making entity. The Council represents Swissmedic’s interests and approves its budget, annual accounts, and reports. Swissmedic manages its activities through strategic goals, based on the revised Therapeutic Products Act.

Its core competencies include authorisation of medicinal products, manufacturing and wholesale licenses, inspections, market monitoring, prosecution, clinical trials, establishing standards, information, and national and international cooperation.

Link for Regulatory Authority

Homepage (swissmedic.ch)

Local Regulation

--> Medical Devices Ordinance (MedDO; SR 812.213)

--> Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219)

These regulations are aligned with EU MDR (2017/745) and IVDR (2017/746) while incorporating Swiss-specific market access and economic operator requirements.

Overview of Regulations

Switzerland regulates medical devices under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). Although these regulations are closely aligned with the EU MDR and IVDR, Switzerland operates an independent regulatory framework.

Following the non-renewal of the Mutual Recognition Agreement (MRA) for medical devices, manufacturers located outside Switzerland must comply with Swiss-specific obligations, including the appointment of a Swiss Authorised Representative (CH-REP), Swiss importer obligations where applicable, economic operator registration, post-market surveillance, vigilance reporting, and device registration through swissdamed.

From 1 July 2026, registration of medical devices, systems, procedure packs and IVDs in the swissdamed UDI Devices module becomes mandatory, with a transition period until 31 December 2026.

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

Register Swiss-based economic operators through the Actors Module of swissdamed and obtain a Swiss Single Registration Number (CHRN), where applicable.
Register medical devices, IVDs, systems and procedure packs in the swissdamed UDI Devices Module in accordance with the applicable implementation timelines.
Appoint a Swiss Authorised Representative (CH-REP) for manufacturers established outside Switzerland where required.
Maintain CE certification where applicable.
Implement Post-Market Surveillance (PMS), Vigilance and Field Safety Corrective Actions (FSCA).
Comply with Swiss labelling and importer requirements.

Documents Required for Switzerland Medical Device Registration

Name and code of the medical device, its classification, its nomenclature, name of the Manufacturer or its authorized representative or importer
CE Conformity Certificates
EC Declaration of Conformity (must be in German, French Italian or English)
Packaging box (Box, Labelling and instructions for use (must be in German, French and Italian))
Technical file
Swiss Authorised Representative Agreement (if applicable)
CE Certificate
EU Declaration of Conformity
Technical Documentation
Risk Classification
Device UDI information
Product Labels
Instructions for Use
Quality Management System Certificate (where applicable)
Post-Market Surveillance documentation

Registration Timeline

Registration timelines vary depending on the device classification, conformity assessment route, and economic operator obligations. Swiss-based economic operators must register before placing devices on the Swiss market. From 1 July 2026, device registration through the swissdamed UDI Devices Module becomes mandatory, with transitional provisions until 31 December 2026.

License Validity

5 Years

Special Labelling Requirements

Labelling, instructions for use and other information available in French, German, Italian. Where applicable, the name and address of the Swiss Authorised Representative (CH-REP) and importer must also appear in accordance with Swiss requirements.

International Medical Device Regulators Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) is a coalition of global medical device regulators working together to expedite the harmonization and convergence of international medical device regulations.

International harmonization serves as a crucial foundation for streamlining regulatory efforts for both regulatory authorities and companies, facilitating regulatory cooperation and leveraging synergies.

Responding to Swissmedic’s request, the IMDRF granted the Swiss Agency for Therapeutic Products the status of Official Observer at Management Committee Meetings. This newly conferred status represents a significant interim achievement towards Swissmedic’s strategic goal of becoming a member of the Management Committee.

Swissmedic continues to actively participate in IMDRF working groups and international regulatory cooperation initiatives.

Reporting Incidents & FSCAs (Vigilance)

Incidents

An incident, as defined by MedDO/ IvDO, is an occurrence linked to a device. Incidents categorized as serious and happening in Switzerland or Liechtenstein are required to be reported to Swissmedic.

Swissmedic systematically gathers and assesses these incident reports.

The purpose of this reporting system is to safeguard the health of patients and users, specifically aiming to prevent the recurrence of serious incidents stemming from issues related to the design, manufacturing, or usage of devices according to MedDO/ IvDO.

Field Safety Corrective Actions (FSCAs)

In cases where problems arise with devices according to MedDO/ IvDO, the manufacturer or the entity assembling the systems or procedure packs (System and Procedure Pack Producer – SPPP) may need to initiate a Field Safety Corrective Action (FSCA). Swissmedic monitors all FSCAs related to devices according to MedDO/ IvDO that are distributed in Switzerland or Liechtenstein. Manufacturers, authorised representatives and importers must comply with Swiss vigilance reporting requirements and report serious incidents and Field Safety Corrective Actions (FSCAs) to Swissmedic in accordance with MedDO and IvDO.

Additional Comments

Economic operators established in Switzerland, including manufacturers, Swiss Authorised Representatives (CH-REPs) and importers, are required to register in the swissdamed Actors Module and obtain a Swiss Single Registration Number (CHRN). Device registration through the swissdamed UDI Devices Module becomes mandatory from 1 July 2026, with a transition period until 31 December 2026.

Manufacturers established outside Switzerland must appoint a Swiss Authorised Representative where required before placing eligible devices on the Swiss market. Post-market surveillance, vigilance reporting and compliance with Swiss labelling requirements remain ongoing obligations throughout the product lifecycle.