國內外智慧醫材法規文件
- 51 (EU)Guidance on Qualification and Classification of Software in Regulation, 2019
- 52 (EU)Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD, 2016
- 53 “MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”, 2020.
- 54 “MDCG 2019-11:Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745-MDR and Regulation (EU) 2017/746-IVDR”, 2019.
- 55 “REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2017.
- 56 “REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL”, 2016.
- 57 “EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Annex 11”
- 58 (IMDRF)Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices Key Terms and Definitions, 2021
- 59 MHRA Guidance: Medical Device stand-alone software including apps (including IVDMDs)
- 60 IMDRF/SaMD WG/N41FINAL, “Software as a Medical Device (SaMD): Clinical Evaluation”