The new Ordinance on In Vitro Diagnostic Medical Devices (IvDO) entered into force on 26 May 2022. This is also the date that the revised Ordinance on Clinical Trials with Medical Devices (ClinO-MD) entered into force, and of the application of the In vitro Diagnostic Devices Regulation (IVDR), which was adopted in the EU in spring 2017.
The main aim of the new regulations is to improve patient safety through the introduction of stricter conformity assessment procedures and performance studies, which ensure the safety and quality of in vitro diagnostic medical devices. In addition, new requirements apply for monitoring, traceability and transparency following placement on the market.
At the online information event, we will cover the new and changed requirements and clarify the specifications in Switzerland.
- General information on the new Ordinance on In Vitro Diagnostic Medical Devices
- Additions and changes to performance studies with devices
- Obligations of economic operators in Switzerland
- Product information and devices on the Swiss market
- Registration and reporting obligations for operators and devices
- Post-market surveillance, vigilance and market surveillance
- In-house Devices, additions and changes
Please save the date now: 3 November 2022.
An invitation, the full programme and an electronic registration form will be sent in August.
- The event will be held online; no additional software is required. More detailed instructions will follow.
- Participation is free of charge.
- The individual presentations will be provided on the Swissmedic website in German, French, Italian and English a few days before the event.
- The presentations will be given in German and will be interpreted simultaneously into French.
- The event will NOT be recorded. The presentations can NOT be viewed at a later date.