Advanced EU MDR Practitioner Training

Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation

Identify the types of devices covered by the EU MDR and the rules for classifying these devices

Describe the obligations of the economic operators and the PRRC

Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971

Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data

Explain the Unique Device Identifier requirements and the relationship with EUDAMED

Introduction to the EU MDR

• History, Purpose & Structure of the EU MDR
• Key Terminology
• Key EU MDR changes
• EU MDR Timelines for Transition

Medical Devices covered by the EU MDR

• What is a device?
• Devices in & out of scope
• Relationship with other Directives
• Legacy Devices

Placing a Device on the Market

• Overview of Chapter II
• Articles 5-9
• Articles 10-16
• Manufacturer Obligations
• Authorized Representative
• Importer & Distributor Obligations
• Person Responsible for Regulatory Compliance (PRRC)
• Articles 17-20
• Articles 21-24

Device Classification

• Types of Risk Class
• Duration of Use
• Types of Body Contact
• Principles of Classification
• Continuous Use
• Classification Rules
• Non-Invasive Rules 1-4
• Invasive Rules 5-8
• Active Devices Rules 9-13
• Special Classification Rules

Routes to Conformity

• Overview of Conformity Assessment
• Annex IX Overview including Chapters 1-2
• QMS: Additional MDR Requirements
• Annex X Type Examination
• Annex XI Product Conformity Verification
• Conformity Assessment of Device Class
• Special Device Conformity
• Derogation from Device Conformity
• Notified Bodies

GSPR and Risk Management

• Chapter I General Requirements
• Risk Management
• Chapter II Design & Manufacture
• Chapter III Device Information

Clinical Evaluation

• Clinical Evaluation Introduction
• Article 61 Exemption and Update
• Annex XIV Part A: Clinical Evaluation and Part B: PMCF
• Summary of Safety & Clinical Performance (SSCP)
• Clinical Evidence for Legacy Devices
• Clinical Data Requirements

Post Market Surveillance and Vigilance

• Chapter VII Post Market Surveillance
• Vigilance Terminology & Reporting
• Trend Reporting
• Article 89
• Additional Considerations
• Medical Device Documentation

Technical Documentation, UDI and EUDAMED

• Annex II & III: Technical Documentation
• UDI Requirements & Timelines
• EUDAMED
• MDCG Guidance Documents