EUDAMED
Compliant registration without any headaches
What, who and when must be registered in EUDAMED?
Economic operators
- Manufacturer
- EU authorized representatives
- Importers
- Producers of systems or procedure packs
…require a separate EUDAMED registration number (SRN) in the actor module for each role, which may already be mandatory depending on the EU member state (e.g. Germany).
Medical devices and IVDs
Each individual product (UDI-DI or REF no.) placed on the market on or after the date of mandatory registration in the EUDAMED product module (planned: early 2026!)requires its own registration with a flood of relevant data that no manufacturer keeps in their ERP system.
Products that are no longer placed on the market at the above-mentioned date may also have to be registered in EUDAMED at short notice
We support you with the challenging task of EUDAMED registrations
Together we will assess your individual situation and find the right solution:
Consulting
Answering questions about:
- Requirements
- Registration obligation
- Registration modalities
- Strategies for product registration
EUDAMED-Support
Interactive support via MS Teams/Zoom for
- User problems
- First steps or uncertainty in the database
Registration
Partial/full outsourcing to our team for
- Database entries
- Provision or verification of login data
- Takeover of all registration processes with minimal effort for you
Your Benefits of Early EUDAMED Registration
- Avoid additional national registrations (in some EEA countries)
- Faster market access
- Legal clarity in the MDR/IVDR context
- Preparation for the mandatory start of EUDAMED
Do you need support with EUDAMED?
Then we look forward to hearing from you and working with you to find the right solutions. Request a free initial consultation*.