This is a password protected decision tree
Request BUDI-DI. Start MEIC Assessment. Gather Administrative Information.
Do you have all Deliverables?
No. Yes. Tips.
- Draft Tech File.
- Know Responsible Parties; Can use DHF.
List out missing deliverable or gaps.
MDR Core Team and Manager.
Get Deliverable Dates.
- Update MEIC with promise dates.
Pre-existing GMDN Code.
Tips. No. Yes.
- Use MCF Form (10948061DOC).
- Takes 1-2 weeks, start in Parallel; Check RA training for form filling to avoid any delays.
Use NFGDC Form on RA Sharepoint.
Need Material Number?. Complete Tab 4 and 10.
- Send completed form to Anton (CM).
- Contact SME.
Intro Table Details.
GMDN Code & Original CE Mark Date. Codes. GSPR (need to refer in TF). Class and Rule.
- Check GMED White Papers in J drive.
- Contact Khaja to route it in agile .
- Check DoC in webtop.
MDA & CND.
No Similar Product. Similar product?.
- Verify if same codes can be leveraged.
- Check the Excel on EU MDR WS Teams Folder.