Software

European Union: 

Software is defined as a set of instructions that processes input data and creates output data.

Software definitions per MDCG 2019-11 given,

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Shall meet the definition of software according to the MDCG 2019-11 and the definition of a MD/IVD  according to Article 2(1) of MDR/IVDR

 MDR classification rules: Rules 9, 10, 11, 12, 13, 15 and 22 Annex VIII

IVDR Classification rules:To classify in vitro diagnostic medical device software all rules shall be considered.

EU Regulations References:

Is your software a Medical Device? Info graphic

MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

US FDA Software as Medical Device (SaMD)

“software intended to be used for more than one or more medical purposes that perform these purposes without being part of a hardware medical device.”

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Meet the definition of software according Federal Food Drug & Cosmetic (FD&C) Act section 201(h) device definition.Some of the software functions are excluded from device definition.

 IMDRF Guidance documents.

Softwareas a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:2013)

Softwareas a Medical Device (SaMD): Possible Framework for Risk Categorization andCorresponding Considerations (IMDRF/SaMD WG/N12FINAL:2014)

Softwareas a Medical Device (SaMD): Application of Quality Management System (IMDRF/SaMD WG/N23 FINAL:2015)

Software as a Medical Device (SaMD): Clinical Evaluation(IMDRF/SaMD WG/N41FINAL:2017)