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IMDRF documents

Technical document

20 October 2021

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

Technical document

20 May 2021

Post-Market Clinical Follow-Up Studies

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Outcome statement

25 March 2021

Korea Virtual Meeting outcome statement

Technical document

21 January 2021

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

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Outcome statement

25 September 2020

Singapore Virtual Meeting outcome statement

Information document

20 April 2020

Maintenance of IMDRF AE Terminologies

Technical document

20 April 2020

Principles and Practices for Medical Device Cybersecurity

Outcome statement

18 March 2020

Closed session management committee meeting outcome statement

Technical document

10 October 2019

Clinical Evaluation

Technical document

10 October 2019

Clinical Evidence - Key Definitions and Concepts