In the frame of CE type and design examination, LNE/G-MED makes available to manufacturers a list of elements to be provided with a view of medical device CE marking.
This list specifies the content of files to be transmitted to the notified body as part of a conformity assessment.
LNE/G-MED is updating those lists and, through this webinar, is informing manufacturers on modifications to take in account when time will come for them to provide such files.
Main items addressed:
Updating / creation of the list of elements to be provided for a Medical Device CE marking in the context of:
- Initial evaluation
- Evaluation of a change
- Renewal Evaluation