TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable devices including substantially equivalent devices.
The first step in the comparability process is for the manufacturer to select an appropriate comparable device. The comparable device should have (or include) the same intended purpose.
Substantially equivalent devices are a subset of comparable devices where the devices are similar to such an extent that there would be no clinically significant difference in safety and performance.
To determine the degree of comparability of devices, consider the clinical, technical and biological characteristics. Higher risk devices require a more thorough and comprehensive evaluation of these characteristics. Once each characteristic and its associated elements have been compared, it can determine the degree of similarity. To demonstrate substantial equivalence, the devices must be similar to such an extent that there would be no clinically significant difference in clinical safety and performance.
Comparisons are ideally based on a single device or lineage.
For information regarding comparable devices, the conclusions regarding the impact of differences on device safety and performance must be endorsed by a suitable clinical expert who has:
- relevant medical qualifications
- direct clinical experience in the use of the device or device type in a clinical setting.
A full curriculum vitae of the clinical expert should be provided.
If it can be established that the clinical, technical and/or biological differences would result in no clinically significant difference in device safety and performance, then the comparable device may be considered ‘substantially equivalent’ to the subject device.
In order to establish substantial equivalence, the differences between the two devices will need to be minimal. Manufacturer need to provide evidence to substantiate the claim, such as pre-clinical (bench testing or in vivo studies) and/or clinical (clinical investigation or post market) data.
Multiple and/or major differences will compromise claims of substantial equivalence. In these scenarios, TGA may consider the devices ‘comparable’ subject to the facts.
It is manufacturer responsibility to ensure that all relevant information relating to the comparable device is provided for clinical assessment – in particular the clinical data that demonstrates its safety and performance.
Link: Clinical evidence guidelines: Medical devices Version 2.0, March 2021