Harmonised Standards — Clinical Investigation

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 14155:2020 + 2024	Good clinical practice (ISO 14155:2020)	GSPR 1, 8, 14 (Clinical investigation)	Current

Related Pages

• Annex XV — Clinical Investigations
• Annex XIV — Clinical Evaluation

Data Layer Source File

eu_mdr/standards/standards-clinical_investigation.json