MedTech Europe – EUDAMED

• DTX for Vigilance – services definition

XSD

• XSD schemas
• Vigilance – XML samples.zip
• XSD schemas + XML samples for each VGL submission report type

DTX Guidelines -> we ask the COM to adapt M2M Access point documentation incl. templates them to VGL module

• Update Guidelines on Data Exchange guidance to include VGL
• Update Machine-to-machine guidance on access Point configuration to include VGL + IT integration process + how to set up an access point linked to 3rd party provider

General remark: Lists in Excel format as a stan-alone documents would be more user-friendly, not in PDF as an annex to a user guide

• List of response error messages received upon XML submission; with triggers to each of the error; allow more than 1 validation error a payload, sending all the corresponding errors in one message

• List of M2M acknowledge message (automatic reply of confirming data submission & registration by EUDAMED)
• List of email notification messages (Identifier, title and content of the email notification Recipient(s) of the email notification – per module and actor role Trigger for the email notification

• VGL transition/onboarding guide i.e. clarification of processes when switching to the mandatory use of EUDAMED for the various VGL reports (see MTE proposal)
• Malfunction processes after mandatory use:  VGL templates used during EUDAMED downtime, timelines for VGL report submission as included in the EUDAMED implementation regulation (to explain in a user guide), list of contact details of authorities where forms can be submitted
• FSCA guidance + helptext + video
• FSN guidance + helptext + flowchart for FSN process + video
• Transparency of VGL information (field by field analysis of information to be released from MIR to the public + guidelines for HCPs/patients which information will be publicly available)
• Factsheet on Transparency and Public Information to summarise all available data/doc to be released by EUDAMED for the general public (revision of this factsheet)