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51
|
EU |
(EU)Guidance on Qualification and Classification of Software in Regulation, 2019
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52
|
EU |
(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
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53
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EU |
“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.
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54
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EU |
“MDCG 2019-11:Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745-MDR and Regulation (EU) 2017/746-IVDR”, 2019.
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55
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EU |
“REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2017.
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56
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EU |
“REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL”, 2016.
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57
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EU |
“EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Annex 11”
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58
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其他國家/組織 |
(IMDRF)Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices Key Terms and Definitions, 2021
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59
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其他國家/組織 |
MHRA Guidance: Medical Device stand-alone software including apps (including IVDMDs)
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60
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其他國家/組織 |
IMDRF/SaMD WG/N41FINAL, “Software as a Medical Device (SaMD): Clinical Evaluation”
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