Module 15 Presentations

4/15/2024

MEDDEV 2.7.1 Rev 4 (2016)  MDR

MDCG 2023-6 (Equivalence for Annex XVI products)

MDCG 2020-5 (equivalence) MDCG 2020-6 (legacy devices) MDCG 2020-1 (software) MDCG 2020-13 (CEAR Template)

MEDDEV 2.7.1 Rev 4 MDR (Annex XIV)

MDR (Article 61)

MEDDEV 2.7.1 Rev 4

April 2024

31

© NAMSA 2021

31

Clinical Data requirements overview

MDR

Key sections of the MDR for Clinical data: • Chapter I Scope and definitions • Chapter VI

Clinical Evaluation and clinical investigations

• Annex XIV

Clinical Evaluation and PMCF

• Annex XV

Clinical Investigations

Guidance on Clinical Data: • MDCG 2020-1 (Guidance on CER for Medical Device Software) • MDCG 2020-5 (Equivalence) • MDCG 2020-6 (Legacy devices) • MDCG 2020-7 (PMCF template) • MDCG 2020-8 (PMCF report) • MDCG 2020-13 (Clinical Evaluation Assessment Report Template) • MDCG 2023-6 (Equivalence for Annex XVI products) • MDCG 2023-7 (Guidance on exemptions and “sufficient levels of access”)

32

© NAMSA 2021

32