Discover how to register your medical devices in Europe: an essential guide for manufacturers outside the EU!

Are you a manufacturer outside the EU and wondering how the medical device registration process works in Europe? Here’s an essential overview to guide you through the regulatory system!

Step 1: Actor Registration
The first step is providing key information about your company, such as the address, details of the regulatory compliance person, and company identification data.

Step 2: Verification by the Authorized Representative
Once the registration is completed, your Authorized Representative will review and validate the UDI and device information in EUDAMED.

Step 3: Final Validation
Before the Competent Authority finalizes the validation, the Authorized Representative conducts a review. When everything is in order, the manufacturer receives the SRN, which is essential for the conformity assessment process by notified bodies.

Why is it important?
Without proper registration and the SRN, it is impossible to obtain the CE mark and access the European market.

Have questions about this process?
Our team is here to help you navigate the regulations and ensure that your device meets all necessary requirements.