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Principes fondamentaux de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745
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Principes fondamentaux de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745

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  1. Principes fondamentaux de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745

Principes fondamentaux de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745

Dans ce cours en ligne gratuit, découvrez les principaux aspects de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745.
Ce cours en ligne gratuit explique l'essentiel de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745. Le cours permet aux apprenants d'étudier les réglementations complexes et ... Ce cours en ligne gratuit explique l'essentiel de la réglementation européenne sur les dispositifs médicaux (EU MDR) - 2017/745. Le cours permet aux apprenants d'étudier les réglementations complexes et détaillées, y compris les améliorations apportées au MDR de l'UE, les éléments des dossiers techniques, les responsabilités après la commercialisation, les exigences accrues liées aux acteurs du marché, etc. Ce cours intéressera tous les professionnels travaillant dans l'industrie des dispositifs médicaux.
COURSE PUBLISHER SM Waqas ImamLean Six Sigma professional, Trainer
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What You Will Learn In This Free Course

  • Explain the three directives on med...
  • Discuss the transformation of old E...
  • Summarize the important improvement...
  • Differentiate the different classes...
  • Explain the three directives on medical devices: IVDD, MDD & AIMDD
  • Discuss the transformation of old EU directives into new regulations, and their relationships
  • Summarize the important improvements with the new EU MDR
  • Differentiate the different classes of medical devices and the criteria for classification
  • List the 22 rules of product classification for a medical device
  • Interpret the route to market for medical devices in Europe
  • Evaluate the roles of different economic operators in EU
  • Describe the applications and requirements of EU-UDI
  • Specify the requirements on EUDAMED in EU MDR
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Course Modules
Course Description
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Module

Introduction to European Regulations on Medical Devices

This module explains the existing relevant European directives for the medical devices' sector in Europe and how these will be replaced with the new EU regulations. The module furt... Read More This module explains the existing relevant European directives for the medical devices' sector in Europe and how these will be replaced with the new EU regulations. The module further elaborates the important changes, improvements, and timelines of enforcement for the new regulations. The module also incorporates important terms from the EU MDR regarding industry. Read Less
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Essential Components of the EU MDR

In this module you will learn the technical documentation required for different classes of the medical devices as per the new EU MDR, the change in archiving period, Post-market s... Read More In this module you will learn the technical documentation required for different classes of the medical devices as per the new EU MDR, the change in archiving period, Post-market surveillance etc. The module then discusses the criteria for classification of medical devices on elements of risk for the device. The module lists the 22 rules which govern the devices classification, and also share some steps as route to the market along-with different Economic Operators' roles in the sector. Read Less
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Module

Reporting Requirements and Identification

In this module, the reporting mechanism and identification of the medical devices as per the new EU MDR regulations are uncovered. The identification mechanism is based on Unique d... Read More In this module, the reporting mechanism and identification of the medical devices as per the new EU MDR regulations are uncovered. The identification mechanism is based on Unique device identifier (UDI) and the important elements within that. Furthermore it also covers details about reporting requirements of EUDAMED. Read Less
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this was part of my training requirement
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      Frequently Asked Questions

      What is meant by the EU 2017 745 MDR regulation?
      What are the common EU MDR specifications?
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      What’s the best course in the latest European Medical Device Regulations?