IMDRF documents

Medical Device Regulatory Review Report: Guidance Regarding Information to be Included

IMDRF Standards Liaison Program Framework

Machine Learning-enabled Medical Devices: Key Terms and Definitions

Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

Competence and Training Requirements for Auditing Organizations

Regulatory Authority Assessor Competence and Training Requirements

Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Post-Market Clinical Follow-Up Studies

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification