Switzerland: The Swiss Regulation Governing IVD Products is Currently Open for Public Consultation

ARQon
Jul 8, 2021
2 min read

Switzerland’s Federal Office of Public Health (FOPH) has announced that on 14 April 2021, the Federal Council opened a consultation on the new Ordinance on In Vitro Diagnostics (IvDO) and the amendments to the Ordinance on Clinical Trials for Medical Devices (ClinO-MD), which will last until 14 September. This legislation is to adapt the Swiss medical device legislation to the EU rules which will come into effect on 26 May 2022.

Update on progress

The process of updating Switzerland’s regulation of both medical devices & IVDs is ran concurrently with the EU‘s effort to create the EU In vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Device Regulation (MDR).

The first stage was completed on 25 October 2017, when the Medical Devices Ordinance (MedDO) was revised for the first time. Parliament passed a partial modification of the Therapeutic Products Act (TPA) and the Human Research Act (HRA) in a second stage on 22 March 2019. Following that, the MedDO was completely revised, and a new law on clinical trials for medical devices (ClinO-MD) was enacted. Stricter criteria for the approval and monitoring of clinical trials and performance testing have been introduced to prove patient safety. The transition of the EU MDR into Swiss medical devices legislation is complete when these provisions take effect on 26 May 2021.

IVD medical devices are to be regulated in a final step in a separate ordinance on in vitro diagnostics (IvDO). The draft is being published in order to ensure than an approved ordinance version is ready to go into force concurrently with EU IVDR on 26 May 2022. Until then, the ClinO is still regulating IVD research before being transferred to the ClinO-MD.

Sources:

Revision of medical devices legislation

New regulations for clinical trials of medical devices