REGULATORY AUTHORITY:Medical device licensing in Switzerland is governed by Swissmedic, the Swiss agency for Therapeutic Devices. Devices are regulated by the EU list of Competent Authorities.

CLASSIFICATION SYSTEM:  Medical devices are classified along with the EU model, using risk-based rules.

Medical Devices: Classes I, IIa, IIb and III.

IVD Devices: Same as the EU IVDD– List A & B, Self testing, all others

TIMEFRAME:

The following timelines apply to manufacturers established in an EU/EEA state or which have an authorised representative in an EU/EEA state13.

•  High-risk devices (Class III, IIb implantable and AIMD): 31 December 2021
•  Moderate-risk devices (non-implantable Class IIb, Class IIa): 31 March 2022
•  Low-risk devices (Class I): 31 July 2022
•  Systems and procedure packs: 31 July 2022

EEA states are the member states of the EU, Iceland, Norway and Liechtenstein. However, the timelines only apply to EU states, Norway and Iceland. Due to the customs treaty14 between Liechtenstein and Switzerland, a manufacturer in Liechtenstein is not obliged to designate an authorised representative in Switzerland.

All other foreign manufacturers are required to appoint a Swiss authorised representative with effect from 26 May 2021.

The labelling is linked to the designation of the authorised representative (see also Chapter 6 of this information sheet).

These provisions apply both to MDD/AIMDD and MDR devices.

LOCAL FEES:

Application review fees: 200 CHF/h

Manufacturer registration: 200 CHF

LICENSE VALIDITY:  Medical devices can remain on the Swiss market for as long as their CE Mark is valid, usually 5 years.

LICENSE TRANSFER: Similar to the EU, this process is not applicable.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER:  If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU.

ADDITIONAL INFORMATION: Swiss manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before they are placed on the market. If the manufacturer is not based in Switzerland, their products may only be placed on the market if they have authorized a person based in Switzerland. The mandate must be agreed in writing.

Mandatory notification for devitalised human tissue: Anyone wishing to import classical and active implantable medical devices with components from devitalised human tissue into Switzerland must notify Swissmedic.

Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Turkey, Ukraine