The Swiss Federal Council issues a new regulation allowing marketing of devices that have not undergone a conformity assessment procedure. This will not exempt the manufacturer from proving performance of the device and essential requirement fulfilment. This exception is restricted to devices intended to be used for preventing and combating the coronavirus in Switzerland. This measure is included in the “Ordinance on Measures to Combat the Coronavirus (COVID-19)”.
For more details, please see the Ordinance at Section 4, Article 4n.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures