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Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition & Technical Documentation

  1. Academy
  2. Medical Devices
  3. MDD to MDR Transition Class

   

Course Fee: $1,500.00

    

Contact us for Early Bird and Group Discounts

Course Objectives

The aim of this 2 day course is to provide information and knowledge about the Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition and Technical Documentation Training on MDR.
Day 1

  • Understand the Medical Device Regulations approach in Europe
  • Understand the Responsibilities and definitions under the MDR
  • Understand the use of Safety and Performance requirements, including the use of hramonized standards
  • Identify the applicable Conformity Assessment Procedure
  • Understand how to prepare for the move from MDD to MDR 

Day 2

  • Understand the development from MDD to MDR
  • Understand the Requirements of the new post marketing part of the technical documentation
  • Understand to align the MDR requirements with international requirements
  • Be prepared for the new CE-Marking

Course Agenda

Day 1 - MDD to MDR Transition

 

Introduction and welcome
Introduction of objective/goals of the training.
 
1. Background information European legislation

2. Scope & Definitions of the MDR

3. Economic operators and Manufacturer’s responsibilities

4. General Safety and Performance Requirements

5. Notified Bodies

6. Classification and Conformity Assessment

7. Presumption of Conformity, Standards and Common Specifications

8. The Quality requirements under the MDR

9. Risk Management under the MDR

10. PMS & Vigilance

11. EUDAMED & UDI

Day 2 - Technical Documentation for MDR

 

Introduction and welcome
Introduction of objective/goals of the training.
 

1. Basics of the Technical Documentation under the MDR

2. Technical documentation in relation to the Conformity assessment Procedure

3. Elements of the „Pre-Marketing“ Technical Documentation

4. Elements of the new „Post-Marketing“ Technical Documentation

5. In Depth review of certain elements of the Technical Documentation

6. How to prepare for world wide harmonization

 

 

Need more information on this class? Contact us.

Katie Lehoullier


Katie Lehoullier joined the TUV USA team in 2016 as Administrative Office Support. Katie assists in the development of TUV USA’s Academy Division as the Training Coordinator.

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