CEU Credits: 0.1
Course Code: ELM-328
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview Introduction
Learning Objectives for this Overview
The Background of the EU MDR 2017/745
1901 – Jim the Horse Tetanus Scandal
1959 – Primodos
1996 – ISO 13485 Medical Devices — Quality Management Systems
2018 – Vaginal Mesh Implants
A Regulatory Evolution
Introduction to EU MDR
The Regulation
Chapters and Articles
Annexes
The EU MDR Timeline
What this means
MDD vs MDR
Chapters VI to X
Clinical Evaluation
Conduct of a Clinical Investigation
Informed Consent
Coordinated Assessment Procedure for Clinical Investigations
Implementing Acts
Post-Market Surveillance System of the Manufacturer
PMS Report
Reporting of Serious Incidents and Field Safety Corrective
Trend Reporting
Competent Authorities
Medical Device Coordination Group (MDCG)
Confidentiality
Data Protection
Penalties
Committee Procedure
Exercise of the Delegation
Product Rationalization
Notified Body Capacity
Economic Operators – Supply Chain Impact
Restricted Substances
Claims Management
Post Market Surveillance & Vigilance
Post Market Surveillance
Vigilance
Clinical Evidence
Labelling, IFUs, Patient cards and Layman’s language
IT Systems
Conclusion
Final Assessment
Certification
