Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Regulatory Framework

Companion diagnostic

Interventional study

B C D

Medicines Authority opinion

MHRA assessment

Qualification Classification

Performance evaluation Scientific Validity Analytical performance Clinical performance

Notified Body assessment

Evaluation report

Clinical Use

Health Institution Exemption

Post market surveillance Market surveillance Vigilance

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

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Post Market

Post Market Surveillance (PMS) Plan

Performance Evaluation Plan (PEP)

Performance Evaluation Report (PER)

Post Market Performance Follow up (PMPF)

Periodic Safety Update Report (PSUR)

Summary of Safety & Performance (SSP)

The Organisation for Professionals in Regulatory Affairs

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