EU Clinical Investigation Application

MDCG 2021-8 Annex 1 β€” preparation and field hints also follow MDCG 2024-3 (CIP), MDCG 2024-5 (IB), and national CA/EC portals (forms may differ by Member State).

Section 1: Clinical Investigation Identification

1.1 Sponsor Organisation

MDCG 2021-8 Β§1.1

Sponsor Contact Person

1.2 Legal Representative (if non-EU sponsor)
1.3 Contact Person for Investigation
1.4 Clinical Investigation Type
1.5 Participating EU/EEA Countries
1.6 Non-EU Countries
1.7 Clinical Investigation Plan (CIP)
1.8 Investigation Titles

Complete scientific title of the investigation

Abbreviated version (max 80 characters)

Plain language version for general public