EU MDR Training

Who should attend?

• This course is ideal for Medical Devices Professionals, who are seeking to improve their skills in the EU MDR environment.
• Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
• This course will be ideal for those working in Quality or Continuous Improvement departments in a medical devices’ industry.
• Moreover, this course will be beneficial for the regulatory affairs professionals who are working on medical device but do not have working knowledge of the EU medical device.
• Above all, this course will be great tool to enhance the skills in Business Development and Strategic Planning department in medical device.

Course Features

This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of eu medical devices regulation and marketing authorization process in detail. Moreover, the course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Course Deliverables

1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
2. You will also be eligible to receive the course study modules, which you can download by login to your course page.

Important Learning Features of EU MDR training: 

EU Medical Device Regulations (MDR and IVDR)

An overview of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), including their scope, key changes, timelines, and implications for manufacturers, distributors, and other stakeholders.

Classification of Medical Devices

Understanding the classification of medical devices based on their risk level and how it impacts the conformity assessment process.

Conformity Assessment Procedures

Explaining the different conformity assessment routes for medical devices, such as self-certification, notified body involvement, and the necessary documentation and steps for each.

Technical Documentation

Detailed guidance on creating and maintaining technical documentation, including design and risk management documentation, clinical evaluation reports, post-market surveillance, and vigilance reporting.

Clinical Evaluation and Performance Studies

The importance of clinical data in supporting the safety and performance of medical devices, and how to conduct clinical evaluations and performance studies.

Labeling and Packaging Requirements

Overview of labeling and packaging regulations, including the Unique Device Identification (UDI) system and other labeling requirements.

Post-Market Surveillance (PMS) and Vigilance

How to establish a post-market surveillance system, collect feedback from users, and handle vigilance reporting in case of adverse events.

Quality Management Systems (QMS)

Understanding the requirements of ISO 13485 and how to implement a robust quality management system for medical devices.

Authorized Representative and Importer Responsibilities

For non-EU manufacturers, the role and responsibilities of the authorized representative and importer in the EU market.

UDI Implementation

Guidelines on implementing the Unique Device Identification system for medical devices.

Clinical Investigations and Notified Body Interactions

Explaining the process of conducting clinical investigations and how to interact with notified bodies for conformity assessments.

Market Access and Post-Market Obligations

Procedures for obtaining CE marking, maintaining compliance, and fulfilling post-market obligations.

In Vitro Diagnostic Devices Specific Requirements

Specific requirements for in vitro diagnostic medical devices under the IVDR, including performance studies, performance evaluation, and performance evaluation reports.

Here you can find some medical device training courses for your reference.

Medical Devices Training Courses