Objective and outcome
The course introduces the most important changes of the Medical Device Directive (MDD) to the new Medical Devices Regulation (MDR). You will be able to understand the key changes in the transition from the MDD to the new MDR. You willl also be able to communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR. Finally, you will be able to identify the next steps for your organization to meet the MDR requirements.
 
Content
You will learn about: 

• 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 quality management system (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

Who should attend
Regulatory affairs role, design and development role, clinical affairs specialist, quality management role, authorized representative, economic operator, consultants.
 
Trainer
Søren Lyngsø-Petersen, CEO, Pharma4ever QA ApS

"Great course. I liked the systematic approach from whether the device was a medical device to post market surveillance report. It was very nice with excersises and discussions in groups"

"Clear, concise, good material, activities, good presenter"

"Great instructor with extensive knowledge about MDR"

Participants, Spring 2021