Clinical investigations according to MDR / MPDG
Information
Type
Miscellaneous
Regulated products
Medical Devices
Topics
Clinical Investigations And Performance Studies
Description
Decision tree clinical investigations MDR / MPDG
Request for authorisation
Notification of a Post-Market Clinical Follow-up investigation in accordance with Article 74(1) of Regulation (EU) 2017/745 (MDR)Notification of a PMCF investigation
Notification of Other Clinical Investigations according to Art. 82 par. 1 MDR in Conjunction with Section 53 MPDGNotification of Other Clinical Investigations
Substantial modifications
SAE and DD reporting for clinical investigations
Temporary Halt, Early Termination or End of a Clinical Investigation
Tags
Organization
Country / Region
Germany
License
Other (Public Domain)