Switzerland | Draft ordinance on in-vitro diagnostics (52 page(s), in German; 51 page(s), in French; 50 page(s), in Italian)

Title of document
Draft ordinance on in-vitro diagnostics (52 page(s), in German; 51 page(s), in French; 50 page(s), in Italian)

Description
On April 5, 2017, the Parliament and the Council of the European Union adopted the new Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR). By aligning Swiss medical device legislation with the two EU regulations, the safety and quality of medical devices, including in vitro diagnostics, should also be improved in Switzerland ensuring better protection of patients. In this regulation, the provisions of the EU-IVDR have been transferred into a new Swiss regulation on in vitro diagnostic medical devices.

Notifying member: Switzerland

Notification: G/TBT/N/CHE/258

Objective tag
Protection of human health or safety; Harmonization

Objective
Harmonization with EU-IVDR, Improve safety and quality of In-vitro diagnostic medical devices for better patient protection.

Documents

• ODiv_FR.pdf
• ODiv_IT.pdf
• IvDV_DE.pdf

Agency responsible
Federal Office of Public Health

Timing:

• Submission: 18/06/2021
• Reception: 18/06/2021
• Distribution: 21/06/2021
• Final date for comments: 20/08/2021
• Proposed date of adoption: N/A