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If you're a Class I medical device manufacturer, registering your products in EUDAMED is a legal requirement under the EU MDR regulation. But for many small manufacturers, navigating the technical details and file requirements can feel overwhelming.
EUDAMED Registration for Class I Devices
Understand the EUDAMED process
We walk you through the steps to register your company, obtain your SRN, and prepare for UDI-DI submissions.
Know what data to prepare
We explain exactly which product details, GTINs, and documentation you’ll need for a successful registration.
Get practical advice tailored to your situation
Whether you’re registering your first product or updating existing entries, we provide advice based on your regulatory context and product class.
Avoid common mistakes
With our guidance, you can reduce the risk of delays or rejections due to formatting errors or missing data.
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