Manufacturers & authorised representatives


Until a corresponding special ordinance (In-vitro Diagnostics Ordinance, IvDO) is issued, two different versions of the Medical Devices Ordinance have been in force since 26.5.2021:

  • Medical Devices Ordinance of Oct. 17, 2001 effective Aug. 1, 2020 (aMedDO, older version of MedDO).
    • Applies to in-vitro diagnostic devices (IVD).
  • Medical Devices Ordinance dated July 1, 2020 (MedDO, latest version of MedDO).
    • Applies to products according to scope of application Art. 1 MedDO (MD)

Incidents


Trend reports & Periodic Summary Report & Periodic Safety Update Report


Field Safety Corrective Actions (FSCAs)

FSN requirements for publication

The defining regulations on the presentation of field safety notices (FSN) concerning products on the Swiss market can be found under Manufacturers & authorized representatives, in the submenu Field Safety Corrective Action (FSCA), >According to MedDO (for MD)