Registrations in EUDAMED
Fast, secure and compliant.
Registrations
According to the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), economic operators – including manufacturers, authorized representatives, importers, and producers of systems or procedure packs – are required to register in the European database system EUDAMED.
For some countries within the European Economic Area (EEA), this registration is currently still voluntary. However, for economic operators based in Germany and a few other countries, registration is already mandatory.
In addition, manufacturers can already voluntarily register their products in EUDAMED.
Your Advantages of Early Registration
- Avoidance of National Additional Registrations (in some EEA countries)
- Faster Market Access
- Legal Certainty in the Context of MDR/IVDR
- Better Preparation for the Full Implementation of EUDAMED
Not sure what exactly applies to you?
- Need clarity on your registration obligations?
- Want an expert to take a closer look?
- Prefer to hand over the entire registration process to us?
Request a free initial consultation now
We assess your individual situation and work with you to develop a tailored solution – legally compliant, efficient, and with minimal effort required on your part.