Table 2.
Documents containing guidelines for the regulation of digital therapeutics and in vitro diagnostics.
| Country | Guidelines to be met for digital therapeutics | Guidelines to be met for in vitro diagnostics |
|---|---|---|
| US | Title 21 of the Code of Federal Regulations (21 CFR) | |
| Germany | Medical Device Regulation (MDR) (16) | In Vitro Diagnostic Regulation (IVDR) (16) |
| France | ||
| UK | The Medical Technologies Evaluation Program (MTEP) | The Medical Device Regulations 2002 (17) |
| Australia | How the TGA regulates software-based medical devices (18) | Australian regulatory guidelines for medical devices (ARGMD) (19); Principles of In Vitro Diagnostic (IVD) Medical Devices Classification |