Harmonised Standards — Quality 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 13485:2016 + 2021	Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)	GSPR 全盘 (Quality management)	Current

Related Pages

• Annex I — GSPR
• Harmonised Standards — Risk Management

Data Layer Source File

eu_mdr/standards/standards-quality_management.json