IMDRF documents

Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

Characterization Considerations for Medical Device Software and Software-Specific Risk

Good machine learning practice for medical device development: Guiding principles

Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators

Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)

In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC)

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

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews