2 docs tagged with "software"

MDR software classification is governed by Annex VIII, Rule 11 of MDR 2017/745. IVDR software follows the same class assignment rules as other IVDs under IVDR Annex VIII. MDCG 2021-24 provides authoritative guidance on MDR Rule 11 application.

MDR Art. 2(1) (software included in definition); MDR Annex VIII Rule 11 (classification); MDR Annex I §17 and §21 (GSPR for software). MDCG 2019-11 and MDCG 2021-24 provide detailed guidance. For IVD software: IVDR Annex VIII Rules 1–7.