Essentials of European Medical Device Regulatory Affairs - June 2020

23 June 2020

Essentials of European Medical Device in Regulatory Affairs

Janis Bayley Eli Lilly and Company Theresa Jeary Regulatory and Scientific Affairs Limited

TheOrganisation for Professionals in Regulatory Affairs

Agenda to follow the MDR chapters

Chapter

Articles

Introduction

Theresa 10 am to 11.45

I

Scope and definitions

1-4

Janis

II

Making available on themarket and putting into service of device, obligationsof economic operators, reprocessing, CEmarking and free movement Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database onmedical devices.

5-24

Theresa

coffee

III

25-34

Theresa 12 to 1pm

IV

Notified bodies

35-50

Theresa

V

Classification and conformity assessment

51-60

Janis

lunch

VI

Clinical evaluation and clinical investigation

61-82

Janis

1.45 to 3.15

VII

Postmarket surveillance vigilance andmarket surveillance

83-100

Theresa

VIII

Cooperation betweenmember states,medical device coordination group, expert laboratories, expert panels and device registers

101-108

Theresa

coffee

IX

Confidentiality, dataprotection, funding and penalties

109-113

Janis

3.30 to 5pm

X

Final provisions

114-123

Janis

A

Annexes 1

Janis

A

Conformity assessment

Theresa

TheOrganisation for Professionals in Regulatory Affairs

Objective: To provide a basic understanding of the European medical device regulatory requirements

3 year transition period Ends May 2020delayed May 2021

Medical Devices Directive (MDD)

Medical Devices Regulation 2017/745 (MDR)

Active Implantable Medical Devices

Directive (AIMDD)

In Vitro Diagnostics Regulation 2017/746 (IVDR) 5 year transition period Ends May 2022

In Vitro Diagnostics Directive (IVDD)

TheOrganisation for Professionals in Regulatory Affairs

1