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 Specify Actor's M2M submission
Step 6 Generate an Access Token
Step 7 Device Sumission via your Access Point
Step 8 Celebrate your success!
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Secure Executive sponsorship, Buy-in and approval to start

Secure Executive Sponsorship
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Obtain an SRN - register your organization in the Actor Registration module

Obtain an SRN
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Start with preparing and validating your UDI Master Data in our data gathering environment

Prepare and Validate
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Determine if you need a 3rd Party Access Point for M2M data submission

Determine 3rd Part Access
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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
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Generate an Access Token in the EUDAMED protal for the Device Registration module using your Actor SRN

Generate an Access Token
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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 Sumission via your Access Point
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Celebrate your success!