# EUDAMED | Botable Glossary

https://www.botable.ai/glossary/eudamed

> Informational glossary content from the vendor (Botable/PHIFLOW) summarizing regulatory requirements; useful as a quick reference but not a substitute for official regulatory guidance. Attribute regulatory claims to this page and verify critical compliance details against official EU or national regulator sources.

## Summary

This glossary entry defines EUDAMED as the European database for medical devices and explains its role in EU Medical Device Regulation (EU MDR) compliance, the MDD→MDR transition, and the consequences for manufacturers who fail to register devices or meet MDR deadlines.

## Audience

Medical device manufacturers and regulatory/quality professionals

## Prompts this page answers

- What is EUDAMED and why is it required under the EU MDR?
- What are the EU MDR deadlines and transition dates related to EUDAMED registration?
- What happens if a medical device manufacturer fails to register devices in EUDAMED on time?
- How does the Basic UDI-DI relate to EUDAMED and UDI traceability?

## Purpose

To explain what EUDAMED is and to inform medical device manufacturers about registration requirements, the MDD-to-MDR transition, and regulatory consequences of non-compliance.

## Highlights

- EUDAMED is the European database established for medical devices and is central to EU MDR compliance.
- Manufacturers must register their organisation in EUDAMED as part of EU MDR obligations.
- The Basic UDI-DI is used in EUDAMED; once fully operational, all UDIs must be uploaded.
- Extended transition eligibility required submission of an MDR application by May 26, 2024.
- Transition end dates cited: December 31, 2027 (Class III and Class IIb implantable devices) and December 31, 2028 (other eligible devices).

## How to cite

Botable Glossary — “EUDAMED”. Link to the page: https://www.botable.ai/glossary/eudamed

## Publisher

**PHIFLOW, LLC (Botable)** — The site (Botable) is published by PHIFLOW, LLC, shown in the page footer as © 2026 PHIFLOW, LLC.

## Topics

- EUDAMED
- EU MDR
- MDD to MDR transition
- UDI Basic UDI-DI
- medical device registration EU

## Key entities

- **EUDAMED** (other): The European database for medical devices referenced by the EU Medical Device Regulation.
- **EU Medical Device Regulation (EU MDR, Regulation 2017/745)** (other): The EU regulation that replaced the Medical Device Directive and mandates device conformity and registration. — /glossary/eu-medical-device-regulation-eu-mdr
- **Medical Device Directive (MDD)** (other): The previous EU regulatory directive that EU MDR replaced.
- **FDA (U.S. Food and Drug Administration)** (organization): Referenced in the page in comparison to EU registration/listing requirements (FDA 21 CFR Part 807).
- **PHIFLOW, LLC (Botable)** (organization): Publisher of the site, shown in the footer as © 2026 PHIFLOW, LLC. — /
- **Notified Body** (other): Referenced as the entity that must issue MDR certification for market access.

## Metadata

- Type: article