EUDAMED Articles & Resources for Medical Device Manufacturers
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Legacy Devices under EUDAMED: Obligations and Exceptions
Introduction Legacy devices represent a particular challenge for medical device manufacturers when it comes to determining whether or not they must be registered in the EUDAMED regulatory database. These medical devices, which comply with the former European directives, may continue to be marketed thanks to the transitional periods provided in the regulations, but they do not benefit from the features
Manual Entry or Automation: Which Approach Is Right for Registering Your Devices in EUDAMED?
Registering medical devices in EUDAMED is a major challenge for all manufacturers. Faced with this regulatory obligation, one crucial question arises: should you rely on manual entry or automate the process? The answer depends primarily on your number of product references — but not only that.
Data Version Management in EUDAMED
Data version management in EUDAMED is a critical issue that is often poorly understood by medical device manufacturers. Unlike a traditional database, EUDAMED is based on strict traceability, in which certain data is considered immutable…
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.
The Benefits of EUDAMED for Manufacturers: Beyond Compliance
EUDAMED is often seen merely as another regulatory requirement for medical device manufacturers. However, beyond simple compliance, this European database offers strategic and operational advantages. This article explores how manufacturers can turn regulatory demands into valuable opportunities to streamline operations and strengthen their market position.
Differences Between EUDAMED and GUDID: What Manufacturers Need to Know
For medical device manufacturers operating internationally, navigating multiple regulatory databases can be complex. EUDAMED (European Database on Medical Devices) and GUDID (Global Unique Device Identification Database) represent two major systems for managing medical device information in the European Union and the United States, respectively. While both databases share the common goal of improving device traceability and safety, they have fundamental
The Complete EUDAMED 2025–2026 Compliance Timeline
Accelerating the Deployment of EUDAMED: Key Dates and New Requirements for Medical Device Manufacturers The rollout of EUDAMED (European Database on Medical Devices) is entering a critical phase. With the publication of Regulation (EU) 2024/1860, deadlines are now clearly defined for medical device manufacturers and other economic operators. This progressive yet firm timeline will structure the implementation of this essential
The 6 EUDAMED Modules — Clearly Explained
EUDAMED (European Database on Medical Devices) marks a major step forward in the regulation of medical devices across Europe. Established under the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746), this comprehensive database is structured into six dedicated modules, each serving a specific regulatory function. Understanding these modules is essential for medical device manufacturers working toward compliance with the
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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