EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
Description:
The objective of this course is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today’s world of medical device manufacture.
Curriculum for this course:
Introduction
Overview Introduction | 1 min 01 secs |
Learning Objectives for this Overview | 1 min 31 secs |
The Background of the EU MDR 2017/745 | 1 min 25 secs |
1901 – Jim the Horse Tetanus Scandal | 1 min 25 secs |
1959 – Primodos | 58 secs |
1996 – ISO 13485 Medical Devices — Quality Management Systems | 1 min 09 secs |
2018 – Vaginal Mesh Implants | 1 mins 10 secs |
A Regulatory Evolution | 1 mins 22 secs |
Introduction to EU MDR | 1 mins 17 secs |
The Regulation | 53 secs |
Chapters and Articles | 1 mins 28 secs |
Annexes | 1 mins 31 secs |
The EU MDR Timeline | 55 secs |
What this means | 1 mins 14 secs |
MDD vs MDR | 57 secs |
Chapters VI to X | 1 mins 10 secs |
Chapter VI
Clinical Evaluation | 1 min 05 sec |
Conduct of a Clinical Investigation | 1 min 45 secs |
Informed Consent | 1 min 08 secs |
Coordinated Assessment Procedure for Clinical Investigations | 1 min 17 secs |
Implementing Acts | 55 secs |
Chapter VII
Post-Market Surveillance System of the Manufacturer | 1 min 01 secs |
PMS Report | 1 mins 29 secs |
Reporting of Serious Incidents and Field Safety Corrective | 1 min 02 secs |
Trend Reporting | 1 min 39 secs |
Chapter VIII
Competent Authorities | 1 min 01 secs |
Medical Device Coordination Group (MDCG) | 1 min 13 secs |
Chapter IX
Confidentiality | 1 min 10 secs |
Data Protection | 1 min 01 secs |
Penalties | 1 min 25 secs |
Chapter X
Committee Procedure | 1 min 23 secs |
Exercise of the Delegation | 1 min 50 secs |
Industry Pain Points
Product Rationalization | 1 min 01 secs |
Notified Body Capacity | 1 min 02 secs |
Economic Operators – Supply Chain Impact | 1 min 10 secs |
Restricted Substances | 1 min 15 secs |
Claims Management | 1 min 09 secs |
Post Market Surveillance & Vigilance | 59 secs |
Post Market Surveillance | 1 min 10 secs |
Vigilance | 1 min 15 secs |
Clinical Evidence | 1 min 21 secs |
Labelling, IFUs, Patient cards and Layman’s language | 1 min 25 secs |
IT Systems | 1 min 30 secs |
Conclusion
Final Assessment
Certification
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