🚀 Need to Register in EUDAMED? Here’s How to Get Started! 🚀
If you’re a manufacturer, importer, or authorized representative in the medical device industry, registering in EUDAMED is key to ensuring compliance with EU regulations. Not sure where to start? Let’s break it down for you!
📝 Step 1: Actor Registration
First, you need to register your organization as an actor in EUDAMED. Here’s how:
Create Your Account: Go to the EUDAMED portal and set up your account.
Submit Your Documents: Provide the necessary legal documents to verify your company. Double-check for accuracy!
Receive Your SRN: After approval, you’ll get your Single Registration Number (SRN), which is essential for all further steps.
🆔 Step 2: Register Your Devices
Next, it’s time to register your devices:
Assign a Unique Device Identifier (UDI) to each device.
Enter Device Details: Include all required information about your device and upload relevant documents like certificates.
📑 Step 3: Link Your Certificates
Ensure all certificates issued by Notified Bodies are linked to your devices and updated regularly in EUDAMED.
🚀 Facing Challenges?
Registration can be tricky—data errors and misunderstandings are common. Make sure you stay updated and check all entries carefully.
🌐 Need More Guidance?
Don’t let the process overwhelm you. Visit our EUDAMED services page to find out how we can make registration simple and hassle-free for you. We’re here to help every step of the way!