EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions

Welcome to Module 10 – EU MDR 2017/745 – Chapter X – Final Provisions. There are ten articles in this chapter: Articles 114 through to 123 inclusive. In spite of the number of articles, this is a relatively short module considering the content, with most of the articles being quite brief. This training module entails a review of the requirements that have to be in place prior to fully implementing EU MDR 2017/745. There are four sections to this chapter, Committee Procedures (Article 114), Delegation (Articles 115 and 116), Amendments (Articles 117 to 119) and Stages on Introduction (Articles 120 to 123).

CEU Credits: 0.1

Course Code: ELM-326

Duration: 30 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Overview

Previous Module

Module Introduction

Learning Objectives for this Module

Section 1: Article 114 – Committee Procedure

Section 1: Article 114 – Committee Procedure

Section 2: Delegation

Article 115 – Exercise of the Delegation

Article 116 – Separate Delegated Acts for Different Delegated Powers

Section 3: Amendments

Article 117 – Amendment to Directive 2001/83/EC

Article 118 – Amendment to Regulation EC Nº 178/2009

Article 119 – Amendment to Regulation EC Nº 1223/2009

Section 4: Stages of Introduction

Article 120 – Transitional Provisions

Article 121 – Evaluation

Article 122 – Repeal

Article 123 – Entry into Force and Date of Application

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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