WHAT IS EUDAMED AND WHY SHOULD YOU CARE?

EUDAMED is the European Union's centralized system that keeps track of medical devices and in vitro diagnostic (IVD) products. It acts as an online database where crucial details about these products are collected and stored, providing a transparent record of their safety, performance, and use.

This system is essential for anyone involved in healthcare from regulators and manufacturers to healthcare providers and the public to access accurate, up-to-date information about medical devices. By making this data available, EUDAMED helps ensure that devices meet high safety standards, reduces the chances of faulty products reaching the market, and boosts public trust in the healthcare system.

HOW DOES EUDAMED WORK?

EUDAMED is divided into six main modules, each focusing on a specific part of a device's lifecycle. These modules work together to collect, store, and share information efficiently:

• Actor Registration - This module collects information about companies involved in the medical device supply chain, including manufacturers and distributors.

• Device Registration - This is where all medical devices are registered and tracked with unique identifiers, ensuring each product is traceable.

• Notified Bodies & Certificates - This tracks the certifications of devices, confirming that they meet the necessary safety standards.

• Clinical Investigations and Performance Studies - This module monitors research studies to ensure that devices continue to meet safety standards during trials and beyond.

• Vigilance and Post-Market Surveillance - After a device is on the market, this section tracks any issues or incidents related to its use.

• Market Surveillance - This module ensures that devices on the market continue to meet regulatory standards and helps prevent unsafe devices from reaching patients.

References: Implementing Regulation (EU) 2024/1860

WHY REGISTER EARLY?

Although the use of EUDAMED is voluntary right now, starting early has advantages. Some regulators, like the Irish Health Products Regulatory Authority (HPRA), are already asking manufacturers to register. And some Notified Bodies may request proof of Actor Registration during audits. By registering early, manufacturers can ensure they are ahead of the curve and ready when EUDAMED becomes mandatory.

EUDAMED'S ROLE IN DEVICE REGISTRATION

Although EUDAMED is not the same as getting approval to sell a device in the EU, it plays a vital role in tracking and managing device data once the CE mark (the EU’s safety certification) is granted. Manufacturers are required to register their devices in EUDAMED, where all the essential information about the product is stored and made accessible to everyone involved in its safety and use.

THE EUDAMED REGISTRATION PROCESS: A STEP-BY-STEP GUIDE

Here’s how manufacturers can register their devices in EUDAMED:

• Create an Account: The first step is to set up an EUDAMED account online.

• Actor Registration: Manufacturers must complete the Actor Registration process, providing details about their company and receiving a unique Single Registration Number (SRN). This number is needed for later steps and is essential for regulatory activities.

• Device Registration: Once the company is registered, they can move forward by registering each of their devices. This includes providing essential details, such as the device's name, intended use, risk classification, and more.

References : MDR Article 29(4), IVDR Article 26(4), EUDAMED UDI Devices User Guide

IMPLEMENTATION TIMELINE AND NEXT STEPS FOR MANUFACTURERS

As of now, only the Actor Registration module is fully functional and required. Once the remaining five modules become operational, a six-month transition period will be initiated. At the end of this period, the use of EUDAMED will become mandatory for all relevant stakeholders, including manufacturers, authorized representatives, importers, and Notified Bodies.

To ensure readiness, manufacturers should take the following steps:

• Complete Actor Registration and obtain your Single Registration Number (SRN) from the designated national authority.

• Compile and structure your UDI and device-related data in alignment with the upcoming UDI/Device Registration module.

• Review and update your quality management system (QMS) to ensure it incorporates procedures and documentation that comply with EUDAMED’s data reporting and traceability requirements.

• Provide training for internal teams on how to navigate and use EUDAMED efficiently, ensuring proper data entry, updates, and compliance once the system becomes fully mandatory.

References : European Commission - EUDAMED Implementation Timeline, MDR Article 123(3)(d) – Application of transitional provisions, Regulation (EU) 2024/1860 – Extends transition periods

TIMELINES AND TRANSITION PERIODS

• The European Commission's latest EUDAMED timeline, published in July 2025, In August 2025, EUDAMED has not yet become mandatory, suggests that the system's five key modules might be ready by the end of September 2025. However, it’s important to note that this timeline is still under review, and exact dates are not yet confirmed.

• It will become mandatory six months after the system’s modules are confirmed as functional. For example, if the confirmation for the device module is given on 1 October 2025, the device registration will be required by 1 April 2026. Additionally, the European Commission's Q&A last year clarified that devices already placed on the market before 1 April 2026, and those continuing to be sold after that date, must be registered by 1 October 2026.

• For “legacy devices” (older models) and fully compliant MDR/IVDR devices, there is no need to register unless there is an issue requiring Post Market Surveillance and Vigilance (PMSV).

• By 2027, the EUDAMED system will be fully operational, with all modules and transition periods for device registration completed. This includes the mandatory use of the Vigilance module, which will be enforced, and the finalization of all registration requirements for devices.

If a device is placed on the market before EUDAMED becomes mandatory but is still sold after the mandatory date, manufacturers will have up to 12 months from the module’s confirmation to register their device.

FINAL THOUGHTS: PREPARING FOR EUDAMED

As EUDAMED becomes the central hub for medical device information across Europe, manufacturers need to start preparing today. This includes:

• Completing Actor Registration to get the SRN.

• Organizing device data in line with EUDAMED’s upcoming requirements.
  Updating quality management systems to handle EUDAMED’s data reporting.

• Training staff to use the platform once it becomes mandatory.

By taking action now, manufacturers will ensure a smoother transition when EUDAMED fully rolls out, helping them stay compliant and keep patients safe.

HOW MORULAA CAN HELP

Morulaa HealthTech supports manufacturers and importers in achieving full EUDAMED compliance under MDR and IVDR. We assist with Actor Registration and SRN issuance, UDI and device data validation, and documentation alignment to meet EU requirements. Our team ensures accurate post-market reporting setup and provides guidance on regulatory timelines under Regulation (EU) 2024/1860. With extensive experience in EU submissions and license management, Morulaa helps streamline your EUDAMED registration, reduce compliance risks, and ensure seamless communication with competent authorities empowering your organization to stay compliant and market-ready in the evolving European regulatory landscape.

References : MDCG Guidance Documents Library