Transitioning From the Soft Transition: Technical Documentation and UDI

Most medical device manufacturers have elected to renew their MDD/AIMD CE certificates early to take full advantage of the soft transition. By doing this manufacturers were able to delay when the technical documentation had to be updated. This strategic delay provides an opportunity to learn from the experience of others, however manufacturers must not wait to long. The required changes to the technical documentation to demonstrate compliance to the MDR is not a simple compilation or reformatting exercise. Manufacturers must plan adequate time and resources to ensure the technical documentation updates are compliant to the MDR and have a submission strategy that avoids the anticipated bottleneck of submissions leading up to 26 May 2024.

During this session the time and resources required to update technical documentation for low risk simple devices and high risk complex devices will be discussed. Speakers will describe to attendees the challenges and roadblocks that were encountered, and any lessons learned.