The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and post-market surveillance in an aim to improve patient safety.
Switzerland brought IvDO into force on 26 May, the same day as the In Vitro Diagnostic Regulation (IVDR) took effect across the border in the European Union. When Switzerland began work on IvDO, it enjoyed barrier-free mutual market access with the EU as part of an arrangement dating back to 2001 that gave it equivalent medical device regulations. However, the failure to update a mutual recognition agreement (MRA) complicated the situation between IvDO being drafted and coming into force.
“In the absence of this updating, the same ‘third country rules’ that have applied to other medical devices for a year will now also apply to in vitro diagnostic medical devices,” the Swiss Agency for Therapeutic Products (Swissmedic) wrote in a statement to disclose the start of IvDO…
