EUDAMED Articles & Resources for Medical Device Manufacturers
Regulatory Intelligence
Stay ahead of the milestones and turn MDR/IVDR obligations into competitive edge. Our practical deep-dives guide you step by step, from UDI-DI preparation to machine-to-machine declarations in EUDAMED.
What is EUDAMED and why is it important for medical device manufacturers?
Digital transformation impacts every sector, including medical devices. At the heart of this regulatory revolution lies EUDAMED (European Database on Medical Devices), an ambitious initiative by the European Commission that redefines transparency and traceability standards for medical devices in Europe. For manufacturers, understanding EUDAMED is not just a matter of compliance but also a strategic opportunity in an increasingly demanding
EUDAMED Terminology: Regulatory Vocabulary Guide
Understanding the vocabulary specific to EUDAMED is essential for navigating the regulatory landscape of medical devices in Europe effectively. This practical guide aims to clarify the technical terms and acronyms frequently used in the context of EUDAMED, thereby enabling industry professionals to communicate more efficiently and better grasp the associated regulatory requirements.
EUDAMED Terminology: Regulatory Vocabulary Guide
Understanding the vocabulary specific to EUDAMED is essential for navigating the regulatory landscape of medical devices in Europe effectively. This practical guide aims to clarify the technical terms and acronyms frequently used in the context of EUDAMED, thereby enabling industry professionals to communicate more efficiently and better grasp the associated regulatory requirements.
The Benefits of EUDAMED for Manufacturers: Beyond Compliance
EUDAMED is more than a compliance checkbox. By standardising data, boosting product visibility and enabling proactive vigilance, the database can streamline processes, cut costs and sharpen competitive edge. This article shows manufacturers how turning regulatory obligations into operational wins can power digital transformation and strengthen market positioning across Europe.
Differences Between EUDAMED and GUDID: What Manufacturers Need to Know
EUDAMED and GUDID both aim to strengthen device traceability, yet they differ sharply in scope, structure and terminology. This article compares Europe’s six-module, Basic UDI-DI-centric database with the FDA’s UDI-focused GUDID, outlining the practical implications—and compliance pitfalls—for manufacturers selling into both regions.
The Complete EUDAMED 2025–2026 Compliance Timeline
EUDAMED is moving from voluntary to mandatory: Regulation (EU) 2024/1860 locks in 2025–2026 deadlines. This concise timeline explains what changes, who is affected and when—so manufacturers, authorised representatives and importers can prioritise registrations, deploy M2M connections, report supply disruptions on time and maintain EU market access.
The 6 EUDAMED Modules — Clearly Explained
EUDAMED’s six linked modules create one EU hub for device traceability—critical knowledge for manufacturers ahead of the 2026 compliance deadline.
MDR and IVDR Regulations: Implications for Device Registration
The introduction of the European regulations on medical devices (MDR 2017/745) and in vitro diagnostic medical devices (IVDR 2017/746) marked a major turning point in the regulation of healthcare products in Europe. These regulations, which replace the former directives, have significantly strengthened device registration requirements, with the aim of improving patient safety and market transparency. This article explores the concrete
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