EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity

Welcome to EU MDR 2017/745 – Module 5 – Chapter V – Classification and Conformity Assessment. There are ten articles in this Chapter V (articles 51 through to 60 inclusive) and in this module we’ll look more closely at the specific details in the regulation surrounding some of the key topics discussed. There are seven distinct areas in this chapter from Classification of Devices (Art 51) to Certificate of Sale (Art. 60).

CEU Credits: 0.1

Course Code: ELM-321

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Overview

Previous Module

Module Introduction

Not in Scope

Learning Objectives for this Module

Chapter V: Classification and Conformity

Article 51 – Classification of Devices – Part 1

Article 51 – Classification of Devices – Part 2

Conformity Assessment

Article 52 – Conformity Assessment Procedures – Part 1

Article 52 – Conformity Assessment Procedures – Part 2

Article 53 – Involvement of Notified Bodies in Conformity Assessment Procedures

Class III and Class IIb Devices

Article 54 – Clinical evaluation consultation procedure for certain Class III and Class IIb Devices

Article 55 – Mechanism for scrutiny of conformity assessments of certain Class III and Class IIb Devices

Certificates of Conformity

Article 56 – Certificates of Conformity

Article 57 – Electronic System on Notified Bodies and on Certificates of Conformity

Article 58 – Voluntary change of Notified Body

Article 59 – Derogation from the Conformity Assessment Procedures

Article 60 – Certificate of Free Sale

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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