New organisational structure with separate Medical Devices Surveillance Sector – Eveline Trachsel heads up the Medicinal Product Authorisation and Vigilance Sector

Swissmedic, the Swiss Agency for Therapeutic Products, started 2024 with a reorganisation that makes responsibilities for medical devices and market surveillance clearer. At the same time, Dr Eveline Trachsel has taken over as the new Head of the Medicinal Product Authorisation and Vigilance Sector.

For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area. This is very important as there has been little harmonisation of medical device regulation globally to date, despite the market being highly international. In addition, these key products for patient treatment are not officially authorised in Switzerland and Europe. Their conformity is assessed – depending on risk class – by the manufacturer alone or additionally by state appointed and monitored inspection bodies (also known as conformity assessment bodies or notified bodies). Accordingly, Swissmedic’s focus is on market surveillance.

The new Medical Devices Surveillance Sector – like its predecessor the Market Surveillance Sector – is responsible for the safety of clinical trials, materiovigilance and market monitoring of medical devices. Its tasks also include monitoring the maintenance and processing of medical devices in hospitals. For a better market overview, the new regulation provides for registration of economic operators and self-registration of medical devices on the Swiss market by the responsible market operators. The database required (Swissdamed) is currently being developed and will be made available in the course of this year.

Swissmedic’s market surveillance activities in the area of medicinal products have been reassigned with effect from 1 January 2024:

The Medicinal Product Licences and Surveillance Sector is responsible for official licences and inspections of clinical trials as well as the manufacture and distribution of medicinal products. The OMCL laboratory carries out testing and batch release for the safety of medicinal products on the Swiss market. This Sector, which is now also responsible for market monitoring of authorised medicinal products, processes reports of quality defects and tackles the illegal trade in medicinal products.

The renamed Medicinal Product Authorisation and Vigilance Sector is responsible for the authorisation of medicinal products (incl. vaccines), for recording and investigating adverse drug reactions reports from the market (known as “pharmacovigilance”) and for implementing the required safety-relevant corrective actions.

New Head of Medicinal Product Authorisation and Vigilance
The new year has also seen Swissmedic welcome a new member of the Management Board: Eveline Trachsel. She has a doctorate in pharmacy and brings wide-ranging experience in the research and development of treatments for different diseases. She also has an Executive MBA in General Management with a focus on digital transformation. Appointed as head of the Medicinal Product Authorisation and Vigilance Sector, she has taken over from Claus Bolte, who stepped down from this role in mid-2023.