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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