The Medical Devices Introductory Course 2020

MDCG and other guidance

• Further guidance documents have been published by the European Commission • Legally non-binding guidance documents • Adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017 • Intended to ensure uniform application of the relevant provisions of the regulations within the EU • Guidance also published by International Medical Device Regulators Forum (IMDRF)

https://ec.europa.eu/growth/sectors/medical- devices/new-regulations/guidance_en

The Organisation for Professionals in Regulatory Affairs

MDCG and Other Guidance: Clinical Evaluation

Title

Reference

Publication

Guidance notes for manufacturers of class I medical devices Guidance on sufficient clinical evidence for legacy devices

MDCG 2019-15

Dec 2019

MDCG 2020-6

Apr 2020

Guidance on clinical evaluation – Equivalence MDCG 2020-5

Apr2020

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

MDCG 2020-1

Mar 2020

IMDRF MDCE WG/N56FINAL:2019 IMDRF MDCE WG/N55 FINAL:2019

Clinical Evaluation

Oct 2019

Clinical Evidence – Key definitions and concepts

Oct 2019

Summary of safety and clinical performance MDCG 2019-9

Aug 2019

The Organisation for Professionals in Regulatory Affairs