EU Medical Device Regulation (EU MDR) – Chapter 7 – Post Market Surveillance, Vigilance and Market Surveillance
Description:
Welcome to EU MDR 2017/745 – Module 7 –Chapter VII – Post-Market Surveillance, Vigilance and Market Surveillance. In this module, we will look more closely at the specific details in the regulation surrounding some of the key topics discussed under this chapter of the regulation. There are eighteen articles in this chapter: articles 83 through to 100 inclusive. Articles 84, 85, 88 and 90 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other fourteen articles.
Curriculum for this course:
Overview
| Course Introduction | 1 min 01 secs |
| Previous Module | 1 min 31 secs |
| Learning Objectives for this Module | 1 min 10 secs |
Section 1: Post-Market Surveillance
| Article 83 – Post-Market Surveillance System of the Manufacturer | 1 min 05 sec |
| Article 84 – Post-Market Surveillance Plan | 1 min 10 secs |
| Report | 1 min 05 secs |
| Article 85 – Post-Market Surveillance Report | 50 secs |
| Article 86 – Periodic Safety Update Report | 1 min 07 secs |
Section 2: Vigilance
| Report | 1 min 12 secs |
| Article 87 – Reporting of Serious Incidents and Field Safety Corrective Actions | 1 min 10 secs |
| Article 88 – Trend Reporting | 1 min 21 secs |
| Analysis | 50 secs |
| Article 89 – Analysis of Serious Incidents and Field Safety Corrective Actions | 1 min 46 secs |
| Article 90 – Analysis of Vigilance Data | 1 min 09 secs |
| Article 91 – Implementing Acts | 1 min 30 secs |
| Article 92 – Electronic System on Vigilance and on Post-Market Surveillance | 1 min 11 secs |
Section 3: Market Surveillance
| Article 93 – Market Surveillance Activities | 58 secs |
| Article 94 – Evaluation of Devices Suspected of Presenting an Unacceptable Risk or Other Non-Compliance | 1 min 20 secs |
| Procedures | 1 min 01secs |
| Article 95 – Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety | 1 min |
| Article 96 – Procedure for Evaluating National Measures at Union Level | 1 min 14 secs |
| Article 97 – Other Non-Compliance | 1 min 18 secs |
| Article 98 – Preventive Health Protection Measures | 1 min 22 secs |
| Article 99 – Good Administrative Practice | 56 sec |
| Article 100 – Electronic System on Market Surveillance | 1 min 30 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-323 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Well done on making a complex subject easy to understand. This is a must do program for anyone selling medical devices to the EU.
This is a very new but also an incredibly detailed topic. This course like the others in this series really make a dull topic interesting but also easier to digest.
Related courses:
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
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies
EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity
EU Medical Device Regulation (EU MDR) – Chapter 6 – Clinical Evaluation and Clinical Investigations
EU Medical Device Regulation (EU MDR) – Chapter 8 – Cooperation Between Member States
EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions
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