CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical Documentation

In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list of the elements to be supplied for the CE marking of their medical devices. The list shall specify the content of the Dossiers to be submitted to the Notified Body as part of their conformity assessment. LNE / G-MED update this list and through this webinar, inform Medical Device Manufacturers, of the changes to be taken into account for future dossiers submissions.

The webinar addresses the following main points:

Update /creation of the list of elements to be provided for the CE marking of a Medical Device in the context of:
• An Initial evaluation
• Evaluation of a change
• Evaluation of a renewal