EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity
Description:
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).
Curriculum for this course:
Overview
| Previous Module | 1 min 01 secs |
| Module Introduction | 1 min 31 secs |
| Not in Scope | 1 min 21 secs |
| Learning Objectives for this Module | 1 min 10 secs |
Chapter V: Classification and Conformity
| Article 51 – Classification of Devices – Part 1 | 1 min 05 sec |
| Article 51 – Classification of Devices – Part 2 | 1 min 10 secs |
| Conformity Assessment | 1 min 08 secs |
| Article 52 – Conformity Assessment Procedures – Part 1 | 1 min 17 secs |
| Article 52 – Conformity Assessment Procedures – Part 2 | 1 min 48 secs |
| Article 53 – Involvement of Notified Bodies in Conformity Assessment Procedures | 1 min 02 secs |
| Class III and Class IIb Devices | 1 min 30 secs |
| Article 54 – Clinical evaluation consultation procedure for certain Class III and Class IIb Devices | 1 min 08 secs |
| Article 55 – Mechanism for scrutiny of conformity assessments of certain Class III and Class IIb Devices | 1 min 05 sec |
| Certificates of Conformity | 1 min 14 secs |
| Article 56 – Certificates of Conformity | 1 min 09 secs |
| Article 57 – Electronic System on Notified Bodies and on Certificates of Conformity | 1 min 30 secs |
| Article 58 – Voluntary change of Notified Body | 1 min 15 secs |
| Article 59 – Derogation from the Conformity Assessment Procedures | 1 min 10 secs |
| Article 60 – Certificate of Free Sale | 1 min 12 secs |
Conclusion
Final Assessment
Certification
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-321 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Conformity of assessment is a key aspect of the new EU MDR and this course explains the requirements in a clear concise manner.
Related courses:
EU Medical Device Regulation (EU MDR) – Introduction
Course code: ELM-316
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions
Course code: ELM-317
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market
Course code: ELM-318
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices
Course code: ELM-319
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies
Course code: ELM-320
EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity
Course code: ELM-321
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5
Course code: ELM-327
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
Course code: ELM-328
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