EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices

Welcome to EU MDR 2017/745 – Module 3 –Chapter III – Identification and traceability of devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices. There are 10 articles in this chapter: articles 25 through to 34 inclusive. Articles 25, 26, 28 and 34 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other six articles.

CEU Credits: 0.1

Course Code: ELM-319

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Previous Module

Module Introduction

Learning Objectives for this Module

Medical Devices

Article 26 – Medical Devices Nomenclature

Article 26 – Medical Devices Nomenclature

Article 33 – European Database

Article 33 – European Database

Article 34 – Functionality of EUDAMED

Identification within the Supply Chain

Registration

Article 29 – Registration of Devices

Article 29 – Registration of Devices

Article 30 – Electronic System for Registration of Economic Operators

Article 30 – Electronic System for Registration of Economic Operators

Article 31 – Registration of Manufacturers, Authorized Representatives and Importers

Summary of Safety and Clinical Performance

Unique Device Identification (UDI)

Article 27 – Unique Device Identification System

Article 27 – Unique Device Identification System

Article 28 – Unique Device Identification Database

Article 28 – Unique Device Identification Database

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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