EUDAMED Journey
Your Journey to EUDAMED Submission
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.
Step 1
Secure Executive Sponsorship
Step 2
Obtain an SRN
Step 3
Prepare and Validate
Step 4
Determine 3rd Part Access
Step 5
Determine 3rd Part Access
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
Start with preparing and validating your UDI Master Data in our data gathering environment
Obtain an SRN
Start with preparing and validating your UDI Master Data in our data gathering environment
Prepare and Validate
Specify your Actor's M2M submission in the EUDAMED portal including any 3rd Party Access Point Details & Services to be used
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
Determine 3rd Part Access
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!