EUDAMED Journey
Your Journey to EUDAMED SubmissionÂ
As the September 2022 deadline to comply with EU MDR quickly approaches, it’s time to take charge of your regulatory compliance strategy and compete to win in the new medical device regulatory climate.
At Innovit, we help companies achieve EU MDR compliance and drive innovation with solutions and processes. Explore the steps to adapt to this new normal across the industry and ensure EUDAMED compliance.
Your Journey to EUDAMED Submission
Step 1
Secure Executive Sponsorship
Step 2
Obtain an SRN
Step 3
Prepare and Validate
Step 4
Determine 3rd Part Access
Step 5
Specify Actor's M2M submission
Step 6
Generate an Access Token
Step 7
Device Submissions via your Access Point
Step 8
Celebrate your success!
Secure Executive sponsorship, Buy-in and approval to start
Secure Executive Sponsorship
Determine if you need a 3rd Party Access Point for M2M data submission
Prepare and Validate
Determine if you need a 3rd Party Access Point for M2M data submission
Determine 3rd Part Access
Specify your Actor's M2M submission in the EUDAMED portal including any 3rd Party Access Point Details & Services to be used
Specify Actor's M2M submission
Generate an Access Token in the EUDAMED protal for the Device Registration module using your Actor SRN
Generate an Access Token
Use this Access Token in the XML file you generate for device submission via your Access Point ( or an Access Point provided by your 3rd Party Solution Provider)
Device Submissions via your Access Point
Celebrate your success!