The Medical Devices Introductory Course 2020

Requirements relating to Clinical Investigations ( MDR v MDD)

Significantly more detailed requirements for clinical investigations (CIs) in MDR

MDR Chapter VI: Articles 62-82 ● Art 70: Application for CIs ● Art 71: Assessment by Member States ● Art 72: Conduct of CIs ● Art 78 Co-ordination assessment procedure for CIs (multicentre studies)

MDR Annex XV CIs

● General Requirements ● Documentation re application for CIs ● Other obligations of sponsor

MDD Article 15; Annex VIII (part) and Annex X (section 2)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

Guidance relating to Clinical Investigations

MEDDEV 2.7/2 rev2: guidelines for Competent Authorities for validation and assessment of a clinical investigation application (Sept 2015)

MEDDEV 2.7/3 rev3: clinical serious adverse reporting under AIMD/MDD (May 2015)

MEDDEV 2.7/4: guideline on clinical investigations: a guide for manufacturers and NBs (Dec 2010)

MDCG 2020-6; 2020-7: PMCF Guidance (MDR)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs