EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions
Description:
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).
Curriculum for this course:
Overview
| Previous Module | 1 min 10 secs |
| Module Introduction | 1 min 31 secs |
| Learning Objectives for this Module | 1 min 21 secs |
Section 1: Article 114 – Committee Procedure
| Section 1: Article 114 – Committee Procedure | 1 min 05 sec |
Section 2: Delegation
| Article 115 – Exercise of the Delegation | 1 min 20 secs |
| Article 116 – Separate Delegated Acts for Different Delegated Powers | 1 mins 29 secs |
Section 3: Amendments
| Article 117 – Amendment to Directive 2001/83/EC | 1 min 07 secs |
| Article 118 – Amendment to Regulation EC Nº 178/2009 | 1 min 20 secs |
| Article 119 – Amendment to Regulation EC Nº 1223/2009 | 1 min 01secs |
Section 4: Stages of Introduction
| Article 120 – Transitional Provisions | 1 min 19 secs |
| Article 121 – Evaluation | 1 min 02 secs |
| Article 122 – Repeal | 1 min 10 secs |
| Article 123 – Entry into Force and Date of Application | 1 min 13 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-326 -
Duration: 30 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This is a must do program for anyone working in the medical device space that sells to the EU market. This is a complex subejct that has been expertly broken down into digestable courses for the learner.
Related courses:
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies
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