EU MDR

EU Medical Device Regulation (EU MDR) – Chapter 7 – Post Market Surveillance, Vigilance and Market Surveillance

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.

CEU Credits: 0.1

Course Code: ELM-323

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Overview

Course Introduction

Previous Module

Learning Objectives for this Module

Section 1: Post-Market Surveillance

Article 83 – Post-Market Surveillance System of the Manufacturer

Article 84 – Post-Market Surveillance Plan

Report

Article 85 – Post-Market Surveillance Report

Article 86 – Periodic Safety Update Report

Section 2: Vigilance

Report

Article 87 – Reporting of Serious Incidents and Field Safety Corrective Actions

Article 88 – Trend Reporting

Analysis

Article 89 – Analysis of Serious Incidents and Field Safety Corrective Actions

Article 90 – Analysis of Vigilance Data

Article 91 – Implementing Acts

Article 92 – Electronic System on Vigilance and on Post-Market Surveillance

Section 3: Market Surveillance

Article 93 – Market Surveillance Activities

Article 94 – Evaluation of Devices Suspected of Presenting an Unacceptable Risk or Other Non-Compliance

Procedures

Article 95 – Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety

Article 96 – Procedure for Evaluating National Measures at Union Level

Article 97 – Other Non-Compliance

Article 98 – Preventive Health Protection Measures

Article 99 – Good Administrative Practice

Article 100 – Electronic System on Market Surveillance

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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