Harmonised Standards — Risk Management

Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/193

Harmonised Standards List (1 standards)

Standard	Title Summary	GSPR Reference	Status
EN ISO 14971:2019 + 2021	Application of risk management to medical devices (ISO 14971:2019)	GSPR 全盘 (Risk management)	Current

Related Pages

• Annex I — GSPR
• Harmonised Standards — Quality Management

Data Layer Source File

eu_mdr/standards/standards-risk_management.json