EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies

Welcome to Module 4 – EU MDR 2017/745 – Chapter IV – Notified Bodies. This training module entails a full review of the role of a Notified Body and how it interfaces with other regulatory bodies including Member States Authorities Responsible for Notified Bodies, The EU Commission and The Medical Device Coordination Group (MDCG). There are sixteen Articles in this chapter: Articles 35 through to 50 inclusive. Articles 37, 38, 40, 41, 43, 49 and 50 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other nine articles.

CEU Credits: 0.1

Course Code: ELM-320

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Previous Module

Module Introduction

Learning Objectives

Chapter IV: Notified Bodies

Article 35 - Authorities Responsible for Notified Bodies

Article 36 - Requirements Relating to Notified Bodies

Article 37 – Subsidiaries and Subcontracting

Article 38 – Application by Conformity Assessment Bodies for Designation

Article 39 – Assessment of Application

Article 40 – Nomination of Experts for Joint Assessment of Applications for Notification

Article 41 – Language Requirements

Article 42 – Designation of Notification Procedure – Part 1

Article 42 – Designation of Notification Procedure – Part 2

Article 43 – Identification Number and List of Notified Bodies

Article 44 – Monitoring and Re-Assessment of Notified Bodies – Part 1

Article 44 – Monitoring and Re-Assessment of Notified Bodies – Part 2

Article 45 – Review of Notified Body Assessment of Technical Documentation and Clinical Documentation

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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