What is EUDAMED?

EUDAMED Definition

EUDAMED is a centralized European database used to collect information about medical devices and their manufacturers. EUDAMED is a key component of the MDR 2017/745 and IVDR 2017/746 regulations. It was designed with the intent to strengthen market surveillance and transparency with regard to medical devices in the EU market. The database provides information related to actor registration, unique device identifier (UDI), device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.

What is EUDAMED

The Cost
of
Mistakes

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.