When can a clinical investigation commence for a Class I device with Ethics Committee approval?

A clinical investigation for a Class I device can commence immediately after the date of notification once Ethics Committee approval has been obtained. This is indicative of the regulatory framework that governs Class I devices, where the process designed to ensure safety and ethical considerations allows for swift initiation of studies.

In this context, notification refers to the requirement to inform the relevant regulatory authority of the planned clinical investigation and demonstrate that all ethical requirements have been met. Given that Class I devices are generally perceived as low-risk, the regulatory environment is streamlined to facilitate quicker access to data collection and testing.

This flexibility is not necessarily available for other classes of devices, which may have more stringent timelines and additional requirements to fulfill before investigations can begin. Consequently, after the notification date, researchers can initiate their studies expeditiously, capitalizing on the approved project to gather data without delays.