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Device1000
Hello, I am interested in hearing your approach and ideas to transition a Summary Technical Documentation File from compliance with the EU medical device directive to the medical device regulation.
Our NB will be reviewing the STED file 2019 as part of the annual MDD surveillance, and then very soon after reviewing the STED file for MDR certification. Therefore, rather than have 2 separate STED files for the device (1 for MDD compliance and 1 for MDR compliance) I would like 1 STED file that covers both, and begin to start preparing it now. For example, it would contain both an Essential Requirements Checklist and a General Safety and Performance Requirements Checklist.
Has anyone else considered this approach/discussed with their NB? What did you decide to do?!
Our NB will be reviewing the STED file 2019 as part of the annual MDD surveillance, and then very soon after reviewing the STED file for MDR certification. Therefore, rather than have 2 separate STED files for the device (1 for MDD compliance and 1 for MDR compliance) I would like 1 STED file that covers both, and begin to start preparing it now. For example, it would contain both an Essential Requirements Checklist and a General Safety and Performance Requirements Checklist.
Has anyone else considered this approach/discussed with their NB? What did you decide to do?!