The following provides a step-by-step process for uploading a Medical Device Manufacturers Medical Device Security (MDS2) Form into the MDRAP MDS2 Library. The MDRAP MDS2 Library is a publicly available repository of Manufacturer’s Disclosure Statement forms uploaded and made available by Healthcare Delivery Organizations (HDOs) and Medical Device Manufacturers (MDMs). The forms are generated by medical device manufacturers to identify the design-specific controls for a device.
NOTE TO HDOs: MDISS recommends using the MDS2 provided by the manufacturer when conducting an assessment on a medical device. MDISS questionnaires should reflect the MDM-specific controls, with the HDO’s implementation identified in the Notes section for each control question. All notes entered by the HDO for all of the control questions will only be displayed in the completed assessment reports entered by the HDOs – they are not displayed in the assessment results that are shared with the Community.
1. Navigate to the MDS2 Library in MDRAP. Note that the delete (Trashcan) icon can only been seen by MDMs. HDOs can upload MDS2 forms, but cannot edit or delete the MDS2 Form.
2. Search for the item in MDS2 Library.
3. If MDS2 is present, review Software Revision.
4. For HDO: If Device and Software Revision exists – STOP – no further action is needed.
5. Add MDS2 by clicking on green UPLOAD MDS2 on the top right of MDS2 Library screen) with new Software Revision details. Be sure to select the same Device and Product Code (3 character identifier below the Class of the device, e.g., HPT as shown in the above screenshot) as the MDS2 Form for the device being uploaded.
6. If not in the MDS2 library, look for the device in the MDRAP device catalog using the Search function.
7. Verify that the FDA Product Code of the device on the MDS2 Form matches the product code/Class of the device in the device inventory by doing a Google Search of the FDA 510K (i.e., in the Google Search enter “FDA 510K” (without the quotation marks) followed by the DEVICE MODEL from the DEVICE DESCRIPTION Section of the MDS2 Form as shown in the screenshot example below.
8. FDA 510K PRODUCT CODE/CLASSIFICATION CODE (sample screenshot from 510(k) summary document:
a. Match PRODUCT CODE AND CLASSIFICATION of FDA 510K search with codes in the Device Catalog.
b. If present, add MDS2 to MDS2 library by entering the Document Release Date and Software Revision (a REQUIRED field) from the MDS2 Form, "drag and drop" the MDS2 Form file, and click on the ADD MDS2 button.
9. If the device cannot be found in the Device Catalog, submit the Manufacturer Name, Device Description, Device Model, Product Code, and the MDS2 Form to via email to email@example.com for MDISS staff to research and add to the Device Catalog.
10. MDISS staff will confirm Product Code, add the device to the Device Catalog, and message back.
11. Following receipt of the confirmation message from MDISS, upload the MDS2 Form to the MDS2 Library following Step 8.b., above.
NOTE: The MDS2 Item will reflect the name of the device in Device Catalog, i.e. if the name will be changed in Device Catalog, also the name of MDS2 item in MDS2 Library list will be changed (the actual MDS2 Form will not be changed).