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)