Fundaments of the EU-MDR

Learn more about the fundamentals of the EU-MDR 2017/746

Training

Fundaments of the EU-MDR 

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.

Implementing the EU-MDR requires a structural approach since the transition to the EU-MDR CE certificates can last over several years.

Do you need to know more than the basics of the MDR? Our 2-day course has been designed to introduce medical device manufacturers to the key changes in the requirements for CE Marking.

 

 

 

 

Program Overview

Duration: 2 days

  • Medical Device Regulation and the Approach
  • Legal and operational structure
  • Scope & Definitions
  • Placing CE marked product on the market
  • EUDAMED & UDI
  • Notified Bodies
  • Classification and Conformity Assessment
  • Clinical Evaluation & Investigations
  • PMS & Vigilance
  • Annex 1 until 17.

Learning Objectives

  • Understand the Medical Device Regulations approach in Europe
  • Understand the structure and purpose of the Medical Device Directives
  • Explain the use of Essential requirements, including the use of (harmonized) Standards
  • Apply the Classification Criteria and Implementation rules
  • Identify the conformity assessment routes
  • Identify Technical Documentation requirements
  • Importance and Role of Clinical Data
  • Identify the importance and contents of Post Market Surveillance.

Who should attend?

Medical device manufacturers, especially if your role is in:

  • Regulatory Affairs
  • Design and Development 
  • Clinical Affairs
  • Quality Management
  • Quality Assurance
  • Internal and External Auditors.

There is no prerequisite for this course but participants will benefit from a basic knowledge of the Medical Device Regulations in Europe.

Costs

Costs: - € 875.-    p/p for a one-day training
            - €1350,-   p/p for a two-day training 

We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.

For more information about this course and/ or in-house training for your organization, please fill in the contact form below:

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