med-device-eu
De la autor
Reconstructed reference notes on EU and UK medical-device software, built from six sources captured 2026-10-13: MDCG 2019-11 rev.1 (June 2025), MDCG 2020-6 (April 2020), MDCG 2020-13 (July 2020), MDCG 2020-7 (April 2020), MDCG 2020-8 (April 2020), and the MHRA software-applications guidance (2023-07-01) with its stand-alone software PDF. Use for SaMD qualification and classification, legacy-device clinical evidence, the clinical evaluation assessment report, the PMCF plan, and the PMCF evaluation report, under EU MDCG guidance or UK MHRA guidance. SCOPE LIMITS: EU MDR and UK MHRA device software only; no IEC 62304, ISO 13485, or ISO 14971 text; no MDR or IVDR regulation body text; MDCG guidance is not legally binding; MHRA guidance is UK-specific; synthesized notes, not legal advice. LICENCE: Per-document: European Commission reuse policy (Decision 2011/833/EU, CC BY 4.0, attribution and indication of changes) for the MDCG documents; Open Government Licence v3.0 for the MHRA guidance; reconstructed notes with
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npx skills add jgsystemsconsulting/jgs-se-knowledge-packs --skill med-device-eu -a claude-code
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