Swissmedic Switzerland Medical Device Registration

Medical devices placed on the market in Switzerland are regulated by the Swiss Agency for Therapeutic Products (Swissmedic). The primary legislation is the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO), which came into force on 26 May 2021 and 26 May 2022 respectively. Both ordinances are substantially aligned with EU Regulation 2017/745 (EU MDR) and EU Regulation 2017/746 (EU IVDR).

Switzerland is not part of the EU single market for medical devices. However, devices placed on the Swiss market must bear the EU CE mark, obtained through conformity assessment under the EU MDR or EU IVDR. Swiss-based Economic Operators must also obtain a Swiss Single Registration Number (CHRN) and register their devices in swissdamed, Switzerland’s medical device database. Manufacturers established outside Switzerland must appoint a Swiss Authorised Representative (CH-REP).

Switzerland medical device and IVD classification

Switzerland applies the same risk-based classification system as the EU. Medical devices are classified as Class I, Class I sterile, Class I measuring, Class I reusable, Class IIa, Class IIb, and Class III under the MedDO and EU MDR. IVDs are classified as Class A, Class A sterile, Class B, Class C, and Class D under the IvDO and EU IVDR. Classification determines the applicable conformity assessment procedure and whether Notified Body involvement is required.

Swiss medical device regulatory pathways

Switzerland recognizes CE marking; therefore, it accepts CE certificates issued by EU Notified Bodies and EU Declarations of Conformity. However, Swiss-specific obligations, including CH-REP appointment, economic operator registration, swissdamed registration, and vigilance reporting apply in addition to CE marking.

CE Marking under EU MDR (as recognized by MedDO)

• Process: The manufacturer completes a conformity assessment under the EU MDR with an EU Notified Body where required by device classification. The manufacturer appoints a CH-REP (where applicable) or registers as an economic operator in swissdamed to obtain a Swiss Single Registration Number (CHRN). The CE mark is then affixed, and the device may be placed on the Swiss market. Devices must also be registered in swissdamed starting 1 July 2026.

• Requirements: Documentation includes a technical documentation file demonstrating conformity with the General Safety and Performance Requirements (GSPRs) of the EU MDR, an EU Declaration of Conformity, EU MDR Notified Body certificates where required, quality management system in compliance with EU MDR Art 10(9) ( ISO 13485 certification is highly recommended), clinical evaluation documentation, and labeling compliant with Swiss requirements, including identification of the CH-REP on the label.

• Timeline: Conformity assessment timelines are based on EU Notified Body workload and device classification.

• Renewal: EU MDR Notified Body certificates are typically valid for up to five years and must remain valid for as long as the device is on Swiss market. Swissdamed registrations must be maintained and updated as required.

CE Marking under EU IVDR (as recognized by IvDO)

• Process: The manufacturer completes a conformity assessment under the EU IVDR with an EU Notified Body where required by IVD classification. The manufacturer appoints a CH-REP (where applicable) or registers as an economic operator in swissdamed to obtain a CHRN. Devices must also be registered in swissdamed starting 1 July 2026.

• Requirements: Documentation includes a technical documentation file demonstrating conformity with the GSPRs of the EU IVDR, an EU Declaration of Conformity, EU IVDR Notified Body certificates where required, quality management system in compliance with EU IVDR Art 10(8) (ISO 13485 certificate is highly recommended), performance evaluation documentation, and labeling compliant with Swiss requirements including CH-REP identification.

• Timeline: Conformity assessment timelines are determined by EU Notified Body availability.

• Renewal: EU IVDR certificates must remain valid. Swissdamed registrations must be kept current.

Key Swiss registration requirements

• Swiss Authorised Representative (CH-REP): Required for all manufacturers established outside Switzerland. Holding an EU Authorised Representative does not satisfy the CH-REP requirement. You must designate a CH-REP based in Switzerland.

• Economic operator registration (CHRN): All economic operators established in Switzerland must obtain a Swiss Single Registration Number (CHRN) within three months of placing devices on the market. Registration is completed through swissdamed. Foreign manufacturers are not required to register directly but are represented through their CH-REP.

• Device registration in swissdamed: Device registration via the UDI/devices module becomes mandatory from 1 July 2026, with a transitional period until 31 December 2026.

• Labeling: Labels and Instructions for Use must be in the official language(s) of the Swiss region(s) in which the device is made available (German, French, and/or Italian, as applicable).

• Post-market obligations: Manufacturers must establish post-market surveillance systems in accordance with the MedDO and IvDO. The CH-REP is responsible for reporting serious incidents in Switzerland, submitting final investigation reports, and communicating FSCAs to Swissmedic.

What documentation is required to place a medical device or IVD on the market in Switzerland?

Documentation requirements depend on device classification and the applicable conformity assessment procedure under the EU MDR or EU IVDR. In general, manufacturers should prepare:

• A complete technical documentation file demonstrating conformity with the General Safety and Performance Requirements of the EU MDR or EU IVDR, as applicable

• An EU Declaration of Conformity referencing the applicable EU regulation (no separate Swiss Declaration of Conformity is required)

• EU MDR or EU IVDR Notified Body certificates, where required by device classification

• QMS certification to ISO 13485, where required

• Clinical evaluation (medical devices) or performance evaluation (IVDs) documentation

• For foreign Manufacturers, a written mandate agreement with the appointed CH-REP.

• Swiss Single Registration number (CHRN) for Swiss-based Economic Operators

• Labeling demonstrating compliance with Swiss language and CH-REP identification requirements

What is a Swiss Authorised Representative (CH-REP) and why do you need one?

A Swiss Authorised Representative (CH-REP) is a legal entity established in Switzerland that acts on behalf of a manufacturer located outside Switzerland. The CH-REP is the manufacturer's local regulatory contact for Swissmedic and carries defined obligations under the MedDO and IvDO that cannot be delegated to an EU or UK Authorised Representative. The CH-REP:

• registers with Swissmedic as an economic operator,

• obtains the CHRN,

• notifies devices where required,

• is responsible for the formal and safety-related aspects of placing the device on the market,

• ensures that the Declaration of Conformity and technical documentation have been drawn up,

• cooperates with Swissmedic on market surveillance and corrective actions,

• and maintains access to technical documentation for inspection.

The appointment must be documented in a written mandate agreement signed by both parties before the CH-REP's details are placed on labels or IFU. Non-Swiss manufacturers cannot place devices on the Swiss market without appointing a CH-REP.

What are the deadlines to comply with device registration requirements in swissdamed?

• Economic operator registration (Actors module): mandatory since August 2024

• Device registration (UDI/Devices module): mandatory from 1 July 2026, with a transitional period for completion until 31 December 2026

• Immediate registration without transitional period from 1 July 2026 for devices subject to serious incident, FSCA, or trend reporting

Although the EUDAMED and swissdamed registration requirements are similar, Manufacturers should note that swissdamed does not accept data imported directly from EUDAMED. The two databases are separate and act independently. Therefore, registrations must be completed separately for each system, and local obligations must be met.

Do foreign manufacturers need a CHRN (Swiss Single Registration Number)?

No. Only Switzerland-based Economic Operators can register for a CHRN in swissdamed. For manufacturers not based in Switzerland, the Swiss Authorized Representative (who must be based in Switzerland) will hold the CHRN and register the manufacturer as an Actor in swissdamed.

Do manufacturers selling in Switzerland need a Swiss importer?

Yes, though this role is not formally designated by the manufacturer. The CH importer is the entity or individual who first places the device on the market. As such, the CH-REP and CH importer roles are often fulfilled by the same entity or individual when in support of a foreign manufacturer. The importer must be identified with the device, either on the labeling, packaging, or other documentation supplied with the device. The importer is obligated to verify the manufacturer has fulfilled their obligations under MedDO or IvDO, register as an Economic Operator in swissdamed, keep records to allow traceability, and participate in post-market surveillance, including withdrawing devices if required and reporting serious incidents.