Solutions Circles Know Before You Go: • Tickets are required and can be picked up at the Solutions Circle check-in desk 20 minutes before start (first-come, first-served). • Max 30 participants per session. Seats cannot be held in between sessions. • Arrive early. Your seat is only held for 3 minutes after a session starts, then released to standby attendees. • Open to full conference registrants only - have your badge ready. • Located in the Exhibit Hall, booth 200.
In recent surveys conducted and published by the European Commission and MedTech Europe, manufacturers continue to face challenges and delays during submissions. A major contributor to these delays and refusals is submission gaps, and it remains an important topic for manufacturers.
The EU MDR requires that technical documentation be written in a clear, concise, and readily understandable language, and that it be updated and maintained throughout the life cycle of the device. The technical documentation must also be organized in a way that allows Competent Authorities and/or other third parties to quickly and easily assess the conformity of the device with the requirements of the applicable regulation. State of the art expectations must also be considered while preparing technical documentation and submission.
This Solution Circle will discuss both common gaps and solutions without introducing additional burden to submission preparation. Additionally, best practices and considerations for new and legacy devices will be discussed.
Learning Objectives:
Identify common submission gaps
Understand MDR expectations on technical documentation
Prepare for TD submission and develop remediation strategies
