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:

Contact Meditrial for immediate assistance in Europe or the US. Free Helpline +1-800-901-4286