| Theme | Software and apps qualification and classification |
| Target Audience | Manufacturers |
| Products Concerned | MD/IVD Software and apps |
| Regulatory reference | MDR (EU) 2017/745 and IVDR (EU) 2017/746
Annex VIII |
| Documents mentioned | IMDRF/SaMD WG/N12FINAL:2014 : Software as a Medical Device : Possible Framework for Risk Categorization and Corresponding considerations. |
The purpose of this guide is to help manufacturers understand the qualification criteria for software falling within the scope of the MD and IVD Regulations and to classify them correctly.
The provisions of this document also apply to applications, whether they run on a cell phone, in the cloud or on other platforms.
In particular, this document contains decision trees to assist in the qualification of a software or application as a MD or IVD. It provides information on the market release of software as a full-fledged MD/IVD and of software considered as a component or integral part of a MD/IVD. It deals with the specific case of modules.