The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.
Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:
- Total and partial joint prostheses
- Cardiovascular devices to promote patency or functional flow
- Implantable pulse generators
- Heart valve prostheses
- Supportive devices – meshes, patches and tissue adhesives