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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 Medical Device Conformity Assessment Bodies

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

Principles of Labeling for Medical Devices and IVD Medical Devices

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices

Competence, Training and Conduct Requirements for Regulatory Reviewers

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Proposed update to document on Post-Market Clinical Follow-Up Studies

Proposed update to Clinical Evaluation documents