In EUDAMED everyone can gain insight into the rule-compliant registration.
For a few days now, we have been watching with excitement as the database gradually fills up. While the first peek was to look for our own company. “Hit! We’re in“ – a scenario presumably happening in many places act the moment. The second glance may be in the direction of competitors.
Have my competitors registered?
Unlike in the past, this time truly everyone can gain insight into the rule-compliant registration in EUDAMED. This database will map the life cycle of medical devices offered in the EU in real time. Various electronic systems will be integrated so that information about medical devices and the respective companies can be collected and processed. This will significantly increase transparency by providing access to information for all.
In addition to the registration of economic operators, i.e., manufacturers (EU and non-EU), importers and European Authorised Representatives,
- UDI (Unique Device Identification) and product registration,
- Notified Bodies and certificates,
- clinical trials and performance studies as well as
- vigilance and market surveillance will also be visible in the databasewill also be visible in the database.
What are the reqirements for registration?
Registration will require an information security statement and, for non-EU actors, a summary mandate statement. In addition to the Member States, Iceland, Liechtenstein and Norway have access to EUDAMED. The UK, Switzerland and Turkey are not included. Registrants from these countries, like other registrants from third countries, will only be able to register with an Authorised Representative (EU-REP).