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Home » EU Medical Device Regulation (EU MDR) - Chapter 4: Notified Bodies

EU Medical Device Regulation (EU MDR) - Chapter 4: Notified Bodies (ELM-320)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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Biopharma Institute LogoTraining Program: EU Medical Device Regulation (EU MDR) - Chapter 4: Notified Bodies
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsWelcome to Module 4 - EU MDR 2017/745 - Chapter IV - Notified Bodies. This training module entails a full review of the role of a Notified Body and how it interfaces with other regulatory bodies including Member States Authorities Responsible for Notified Bodies, The EU Commission and The Medical Device Coordination Group (MDCG). There are sixteen Articles in this chapter: Articles 35 through to 50 inclusive. Articles 37, 38, 40, 41, 43, 49 and 50 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other nine articles.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

EU Medical Device Regulation (EU MDR) - Chapter 4: Notified Bodies course is included in the following Professional Certification Programs:

EU Medical Device Regulation (EU MDR) for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Previous Module
Module Introduction
Learning Objectives

Chapter IV: Notified Bodies
Article 35 - Authorities Responsible for Notified Bodies
Article 36 - Requirements Relating to Notified Bodies
Article 37 - Subsidiaries and Subcontracting
Article 38 - Application by Conformity Assessment Bodies for Designation
Article 39 - Assessment of Application
Article 40 - Nomination of Experts for Joint Assessment of Applications for Notification
Article 41 - Language Requirements
Article 42 - Designation of Notification Procedure - Part 1
Article 42 - Designation of Notification Procedure - Part 2
Article 43 - Identification Number and List of Notified Bodies
Article 44 - Monitoring and Re-Assessment of Notified Bodies - Part 1
Article 44 - Monitoring and Re-Assessment of Notified Bodies - Part 2
Article 45 - Review of Notified Body Assessment of Technical Documentation and Clinical Documentation


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).

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