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…
