EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies
Description:
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.
Curriculum for this course:
Introduction
| Previous Module | 1 min 01 secs |
| Module Introduction | 1 min 31 secs |
| Learning Objectives | 1 min 21 secs |
Chapter IV: Notified Bodies
| Article 35 – Authorities Responsible for Notified Bodies | 1 min 15 secs |
| Article 36 – Requirements Relating to Notified Bodies | 1 min 45 secs |
| Article 37 – Subsidiaries and Subcontracting | 1 min 31 secs |
| Article 38 – Application by Conformity Assessment Bodies for Designation | 1 min 10 secs |
| Article 39 – Assessment of Application | 1 min 48 secs |
| Article 40 – Nomination of Experts for Joint Assessment of Applications for Notification | 1 min 24 secs |
| Article 41 – Language Requirements | 1 min 30 secs |
| Article 42 – Designation of Notification Procedure – Part 1 | 1 min 10 secs |
| Article 42 – Designation of Notification Procedure – Part 2 | 1 min 30 secs |
| Article 43 – Identification Number and List of Notified Bodies | 1 min 14 secs |
| Article 44 – Monitoring and Re-Assessment of Notified Bodies – Part 1 | 1 min 30 sec |
| Article 44 – Monitoring and Re-Assessment of Notified Bodies – Part 2 | 1 min 29 secs |
| Article 45 – Review of Notified Body Assessment of Technical Documentation and Clinical Documentation | 1 min 15 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-320 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
With the fast-approaching deadline for the new EU MDR this program is the perfect way to get workforce up to seep quicky with his extremely critical regulation.
Understanding notified bodies is a key element of the new EU MDR, this course explains all you need to know in a clear concise manner.
Related courses:
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
EU Medical Device Regulation (EU MDR) – Introduction
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices
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