2 docs tagged with "software"

Detailed guidance on software as a medical device (SaMD) and artificial intelligence/machine learning (AI/ML) medical devices under the UK MDR 2002 — qualification, classification, technical documentation requirements, and MHRA's AI Change Programme.

How standalone software is classified as a medical device under the UK Medical Devices Regulations 2002 — the qualification test, applicable classification rules, MHRA guidance on AI and machine learning, and comparison with the EU MDR/MDCG approach.