EUDAMED and the European Commission: Ensuring Medical Device Safety

We’ve talked in our previous blog about the new rules for medical devices in Europe. Now, let's learn about EUDAMED, a special online system, and the European Commission's job in making sure these rules are followed. In the blog you will also find a step-by-step guide on how to use the database.

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What is EUDAMED?

EUDAMED is a big online database that stores information about medical devices used in Europe, a guide on how to use the database can be found at the end of this blog. Here’s what the EUDAMED it does:

Transparency: EUDAMED makes sure everyone can see important information about medical devices. It includes details such as which devices are allowed to be sold, which companies made them, and how safe they are.
Monitoring: It helps track whether medical devices are working well and safely, making sure patients are protected.
Coordination: It facilitates better communication between national competent authorities, the European Commission, and other stakeholders, ensuring a smoother regulatory process and more consistent application of the MDR rules.

EUDAMED is helpful for both health authorities (the people who make sure devices are safe) and the public, so we can all trust that medical devices are safe to use.‍

What Does the European Commission Do?

The European Commission is the "rule-maker" of the European Union. Here’s what it does for medical devices:

Writing the Law: The Commission drafts and updates EU legislation related to medical devices to improve market oversight and protect public health. The MDR was developed to provide a more stringent regulatory framework compared to its predecessor, the MDD.
Making Sure Rules Are Followed: The Commission checks that every country in the EU is following the same laws.
Watching Over EUDAMED: It also makes sure EUDAMED is working properly and that the information in it is correct.
Helping Everyone Understand: The Commission helps countries and companies understand how to follow the rules, making sure all medical devices are safe and work properly.

‍Why Is This Important?

EUDAMED and the European Commission help keep track of all medical devices in Europe, making sure they are safe and work properly. This helps protect people's health and ensures that doctors and hospitals can trust the devices they use.

The European Commission is working hard to make sure that everything runs smoothly, so we can all feel safe and confident when using medical devices.