Focus campaigns

Swissmedic monitors the medical device market in a targeted manner and reviews certain focus topics in the Swiss market annually – from economic operators to devices. The aim of these focus campaigns is to raise economic operators’ awareness of their obligations.

The focus topics are selected as part of Swissmedic's annual planning. In doing so, Swissmedic takes into account, among other things, national and international market feedback, the evaluation of suspicious activity reports and queries, and changes in the legal framework. The sample is selected according to certain criteria. The scope of the review varies depending on the topic and the data pool available.


Swissmedic reviews Swiss importers (PDF, 1 MB, 18.10.2023)Swissmedic reviewed 30 importers of medical devices for compliance with legal requirements.


Request to check mandates relating to ECM certifications (PDF, 215 kB, 22.06.2023)Swissmedic requests Swiss authorised representatives (CH-REP) to check their mandates with regard to ECM certifications. The following letter was sent to all Swiss authorised representatives registered with Swissmedic.


Swissmedic inspects Class I manufacturers in Switzerland (PDF, 3 MB, 27.03.2023)Swissmedic inspected 27 Class I medical device manufacturers in Switzerland regarding compliance with the new requirements and market observations


Swissmedic inspects Swiss authorised representatives (CH-REP) (PDF, 951 kB, 03.10.2022)Swissmedic carried out systematic, focused inspections of Swiss authorised representatives (CH-REP) in the first half of 2022 to check their implementation of the provisions in the market.