An HDO user or a Proxy user working on behalf of an HDO can request an MDM to complete an MDM Assessment for a specific device.
The following describes the process for sending an email request to a manufacturer to complete the MDM risk assessment questionnaire for a specified medical device. The email to the manufacturer includes a link to MDRAP for the manufacturer to complete the MDM questionnaire for the selected medical device.
1. Log In to MDRAP.
2. On the MDRAP Home page, click on the View Device Inventory link in the middle of the page or click on Device Inventory on the blue navigation bar across the top of the screen.
3. The Device Inventory screen opens up displaying the Device Inventory for the user's organization.
4. Click on the ADD DEVICE + button on the right-hand side of the screen to begin requesting a PPA.
5. A popup window is displayed for the user to enter the device of interest in the search bar. In the screenshot below the IMEC 10 Patient Monitor was entered in the search bar.
6. The user selects the device by clicking on the device name of interest.
7. A popup window is displayed for the device being added. Click on the Assessment Phase drop-down box to view selections and select Pre-Procurement.
8. The Add to Pre-Procurement popup window is displayed. The user completes the Manufacturer Contact Information section with Manufacturer First and Last Name and Email Address as shown in the example below (this information must be completed in order to send the email to the manufacturer). The system presents the manufacturer designated contact information and gives users the option to add another email destination if so desired. If the requester is acting as a proxy for an HDO/several HDOs, he will need to select the correct organization from the dropdown box at the bottom of the popup window. For an HDO the drop-down box is not shown.
9. The invitation message template may be edited by the user prior to sending. Users may include their contact information, the desired timeline, device configuration options of interest, or any other details they would like to convey to the manufacturer.
10. The user sends the email to the manufacturer by checking the "Send Invitation while Saving" checkbox when saving the pre-procurement device, or by adding the Device to the list of Pre-Procurement devices, and clicking the "Send Invitation" icon (highlighted arrow) for the relevant Pre-Procurement Device.
11. An example of the email sent to the manufacturer can be seen in the screenshot below. Any manufacturer staff with an MDRAP account can complete the Assessment request. If the manufacturer staff working on the assessment does not have an MDRAP account, there's a link provided in the email to complete the MDRAP user registration request (the manufacturer must register as a "Manufacturer" Organization Type). The email also provides a link to start the pre-procurement assessment.
12. The status of the Pre-procurement request is displayed in the organization's Device Inventory (i.e., Initiated and Sent). Users can also add the device to the inventory from the Pre-procurement Assessment list by clicking on the arrow ( ) to the far right of the device of interest.
13. NOTE: Pre-procurement Assessments will not appear on the Assessment list until the Assessment is completed and submitted by the manufacturer.
14. If a user tries to request a Pre-Procurement Assessment (PPA) on a device for which the manufacturer has already completed and submitted an MDM assessment for that device, the user will get a notification that the device has been assessed by the manufacturer and a link is provided to view the submitted MDM assessment as shown in the screenshot below.
If the MDM has restricted the access to his assessments then the notification is shown as below and the user needs to go to Assessments' Community tab to request access for the assessment in question.