Reg Classification of Devices

Describing the regulatory classification of devices is essential for ensuring that potential participants, stakeholders, and regulatory bodies understand the level of oversight and safety considerations involved in the study.  

The Trials Accelerator can also assist with device classification and subsequent regulatory pathway processes, preparing documentation for ethics applications, pre-submission meetings with the competent authority and regulatory submissions, data protection impact assessments and submissions to CRDO for studies that are going to be delivered in CRFG.