What MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR requires
This guidance provides criteria for qualifying software as a Medical Device (MDSW) or In Vitro Diagnostic (IVD) Medical Device and outlines the risk-based classification rules under EU MDR and IVDR. Manufacturers must apply MDR Annex VIII, Rule 11, which classifies software based on the significance of the information provided and the healthcare situation, to determine if their AI/ML software is Class I, IIa, IIb, or III.
Pillar: Medical & Healthcare · Authority: European Commission - Medical Device Coordination Group (MDCG) · Version: 1.0.0 · Last updated:
Primary source: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf
SHA-256 integrity: 966892847706e617b144c5881053d231d3e7653f09a9ea4c7d3b2d80fed731f8
Primary Citations — 7 traced to source
- MDCG 2019-11, Section 2.1: Qualification criteria for MDSW
- MDCG 2019-11, Section 3.2: Decision steps for qualification of software as a medical device
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