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
  • UDI-DI requirements in Annex VI (to be released in Q1 2020)

Learning Objectives:

Upon completion of this course, learners will have acquired:

  • A good understanding of the European regulatory model according to the MDR 2017/745 and know how to apply the key principles.
  • Know how to use related product specific directives in conjunction with the MDR
  • Understand the combination products requirements and how to apply interactions with the directive for medicinal products, tissue of animal origin products and others as per demarcation guidance.
  • Make decisions on what clinical data are needed for CE-mark and how to safely keep the product on the market in compliance with the post market surveillance requirements of the MDR and related guidance documents
  • Apply the requirements for technical file and design dossier
  • Understand how Notified Bodies are designated and what their interactions are with MDCG and expert groups
  • Apply 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

330 min

Related resources:

Case studies:

Basic Account: € 925.00
Premium Account: € 694.00

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