Course Description

The European Medical Device New Regulation 2017/745

Course Description:

This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics:

  • Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities)
  • Structure of the EU MDR and other related regulations
  • Definition and classification of medical devices (MEDDEV 2.4/1 Rev 9)
  • Conformity assessment procedures and routes
  • Quality system requirements
  • General safety and performance requirements in Annex I and the use of harmonized standards
  • Clinical evaluations, including references to MEDDEV 2.7.1/Rev 4 and clinical investigations
  • Technical file and design dossier requirements
  • Medical device vigilance
  • Designation and oversight of notified bodies by the Medical Device Coordination Group (to be released in Q1 2019)
  • UDI-DI requirements in Annex VI (to be released in Q1 2019)

Watch the Course Trailer:

 

 


Learning Objectives:

Upon completion of this course, learners will have acquired:

  • Comprehension of the European regulatory model according to MDR 2017/745 and how to apply its key principles
  • Knowledge of how to use relevant product-specific directives in conjunction with MDR
  • Understanding of combination product requirements and how to perform directive-based interactions with medicinal products, animal tissue origin products, and others, as per the demarcation guidance
  • Decision-making skills regarding what clinical data is needed for CE-marking and how to safely keep marketed products in compliance with MDR post-market surveillance requirements and related guidance documents
  • Application of the requirements for technical files and design dossiers
  • Insight into how notified bodies are designated and how they interact with MDCG and expert groups
  • Implementation of the UDI-DI requirements outlined in Annex VI

Who Should Enroll:

Regulatory Affairs Associates and Managers; Quality Assurance Associates, Managers, and Engineers; Manufacturing Engineers; Supply and Purchasing Managers; Design and Validation Engineers; Notified Body, Internal, and Lead Auditors; Regulators; Electrical Safety Engineers; Pre-Clinical Study Managers; Clinical Affairs Directors; Clinical Project Managers; Export Managers; and R&D Engineers are welcome to participate in this course.


Prerequisite Knowledge/Requirements:

Knowledge of basic regulatory principles outlined in the GHTF documents is encouraged. The course does, however, cover MDR  basic principles.


Subject Matter Expert:
Danielle Giroud
Mona Magnuson

Duration:
285 min

Release date:
01/16/2019

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 841.00
Premium Account: € 631.00

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