Overview medical devices

Checklist for the inspection of sterile services department
The checklist below is based on "Good practice for the reprocessing of medical devices", 2016 version (available in German, French, Italian). Swissmedic uses the checklist as an aid when inspecting hospitals. It can be used by healthcare institutions to conduct gap analyses of their current situation in comparison to requirements as per the "Good practice" document and for internal audits, etc

Updated PDF forms

New information on the EU Regulations (MDR, IVDR)
The European competent authorities have elaborated and published a roadmap for implementing the MDR and IVDR in Europe.
A European working group has published a FAQ document for both the MDR and IVDR.