This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.

Benefits to Your Business

• Understand the key changes in the transition from the Medical Devices Directive to the new Medical Devices Regulation
• Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR
• Identify the next steps for your organization to meet the MDR requirement

Learning Objectives

On completion of this training, participants will be able to:

• Explain the changes in the structure and administration of the regulation
• Recognize new economic operators affected by the regulation
• Identify key changes to the requirements concerning the following steps for conformity assessment:
  • Check device is within the scope of the MDR
  • Determine risk class of device
  • Select conformity assessment procedure
  • Identify applicable safety and performance requirements
  • Assemble technical documentation
  • Apply conformity assessment procedure
  • Assign unique device identification (UDI)
  • Complete Declaration of Conformity (DoC)
  • Affix CE mark
  • Post-Market Surveillance and Updates
• Explain the main impacts on the QMS relating to the above steps, including:
  • Frequency, extent and conduct of audits
  • Electronic data management and public access to data
  • Clinical investigations, clinical evaluation and post-market surveillance
  • Roles of commercial partners
• Communicate the transition arrangements as stipulated within the regulation

Intended Audience

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.

Prerequisites

Good understanding of the existing Medical Devices Directive (93/42/EEC).