EUDAMED: A Guide for Medical Device and IVD Manufacturers

The Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Regulation 2017/746 (IVDR) introduced the requirement for a new electronic system called European Database for Medical Devices (EUDAMED). Manufacturers will use EUDAMED to register and maintain specific information about their products and maintain that data throughout the device lifecycle.  

Click here to access our EUDAMED Service for medical device compliance.

Initially, EUDAMED was scheduled to go live in time for the original MDR and IVDR application dates. But shifting deadlines for manufacturer compliance and delays in EUDAMED development seemed to push mandatory use of EUDAMED indefinitely. Years after MDR’s original application date, parts of EUDAMED are still in development. However, with final MDR and IVDR transition deadlines looming and EUDAMED nearing completion, medical device and IVD companies need to start incorporating EUDAMED reporting into their compliance activities.  

In this article, we take a closer look at what manufacturers need to do to comply with EUDAMED requirements and when. 

What is EUDAMED?

EUDAMED is a multifunctional electronic system that will be used by Economic Operators (Manufacturers, System/Procedure Pack Producers, EU Authorized Representatives, and Importers), Sponsors, Member State Competent Authorities, Notified Bodies, healthcare professionals, and the public. It will serve as a database of information about devices sold in the EU market, with the goal of achieving better accessibility, transparency, and quality of information about device safety throughout the lifecycle. It will also serve as a key mechanism in the traceability of specific devices. EUDAMED will house current information about device registration, post-market activities such as adverse event reporting, clinical investigations, and more.  

The Actor Registration, UDI and Device Registration, and Notified Body modules are live and available for voluntary use; the remaining modules are still in development.  

When is EUDAMED Registration Required?

MDR and IVDR initially stated that EUDAMED registration would be mandatory only when all modules were operational. Under this mandate and the current development timeline, EUDAMED would not be required until at least 2027. Until then, registration requirements as stated in the device directives would still apply. 

In July 2024, the European Commission introduced a framework allowing individual EUDAMED modules to become mandatory module by module, rather than waiting for the entire system to be fully operational. Specifically, under its provisions, each module becomes mandatory six months after it is declared functional which would follow from an independent audit and the publication of a Commission notice in the Official Journal of the EU. The arrival of Regulation 2024/1860 therefore marked a pivotal shift to legally enabling operational modules to be rolled out gradually. 

Although the initial timeline for the gradual roll out was published with planned OJEU publication date for the Actors, UDI/Device Registration and Notified Bodies and Certificates in July 2025, this timeline will be updated based on latest feedback from the European Commission.

It is important to note that the Actor, UDI/Device Registration, and Notified Bodies & Certificates modules of EUDAMED are already available for voluntary use and are widely utilized. 

As of now, the system includes: 

• Manufacturers: >28,000 

• Authorized Representatives: >2,500 

• Importers: >9,000 

• System and Procedure Pack Producers: >1,300 

• Devices / Systems / Procedure Packs: >82,100 

• Certificates: > 1450 

How to Register as an Actor in EUDAMED

All economic operators, such as manufacturers, System/Procedure Pack Producers, EU Authorized Representatives, and Importers must register in EUDAMED using the Actor Registration module. Distributors are considered economic operators but are excluded from the EUDAMED registration requirement and are not considered “Actors” under the MDR. 

To register as an Actor, go to the EUDAMED registration page and click “Create your EU login account.” 

From here the process is quite simple, but a review of the European Commission’s Actor Module User Guide for a more detailed look at the process is suggested. Actor registration for manufacturers requires basic information about your organization; however, it’s essential to have all the required documentation completed to ensure the registration goes smoothly, including: 

• • Mandate Summary Document (non-EU manufacturers only) 
  • Declaration on Information Security Responsibilities 

You must also identify key personnel in the registration process: 

• • EU Authorized Representative (non-EU manufacturers only) 
  • Person Responsible for Regulatory Compliance (PRRC) (include all PRRCs in your organization) 

You will also need to assign at least two Local Actor Administrators (LAAs) for the Actor Registration. The person creating the Actor registration will be the primary administrator who will approve account access for other individuals in the organization. 

Once your registration is submitted, it will be routed to your Authorized Representative for review (if applicable). It will then be routed to the Competent Authority for final review and approval. The Competent Authority may request corrections as part of the review process. The timeline for Actor Registration reviews can vary among Competent Authorities based on their available resources. 

Once your Actor Registration is approved, your company will be published in the EUDAMED Public Database and you will receive your ActorID/Single Registration Number (SRN). The SRN is used to track your company’s activities in the EU device market and is listed on a number of documents, such as Field Safety Notices, Declarations of Conformity, Notified Body applications, etc. 

With the Actor Registration complete, you’re ready to move on to the UDI/Device registration. 

Registering your Medical Device or IVD in EUDAMED

Manufacturers will be required to register their devices in EUDAMED using the UDI/Devices module. EUDAMED device registration is separate from the marketing authorization process and occurs after you obtain CE Marking. You must also complete the Actor Registration before the Device Registration. 

The device/UDI module is an extension of your device labeling in a sense, as it provides a repository for information associated with your UDI-DI. It will serve as a key resource of information about your devices to other members of the device industry, healthcare providers, and the public. 

To start your device registration, you will log into the EUDAMED registration page using your Actor Registration login credentials, then click “Register a new Basic UDI-DI” (or “Register a legacy device,” as applicable). Custom devices are exempt from EUDAMED registration. 

The EUDAMED UDI Devices User Guide provides thorough instructions for completing the device registration process. Here’s a list of device details you will need to complete the registration: 

• • Basic UDI-DI, UDI-DI and type of UDI-PI 
  • UDI issuing agency 
  • European Medical Device Nomenclature (EMDN) Code 
  • Device classification and characteristics (e.g., sterile, single use, containing latex, etc.) 
  • Trade and/or model names 
  • Member State(s) where the device is currently or will be marketed 
  • Design and/or manufacturing company names, if applicable 

Any changes to this information will require a new UDI, which will need to be registered in EUDAMED. 

Manufacturer Obligations for the Certificates and Notified Bodies Module

While the Certificates and Notified Bodies module will mostly be used by the European Commission, Competent Authorities, and Notified Bodies, some of the information in this module will be accessible to the public. Manufacturers must complete the Actor registration and Device/UDI registration before their Notified Body can register conformity assessment certificates or upload their Summaries of Safety and Clinical Performance (SSCP) and/or Summaries of Safety and Performance (SSP), if required. The SSCP/SSP will be accessible to the public, including healthcare providers and patients, and will provide an up-to-date summary of clinical data and other information about the safety and performance of the medical device or IVD. Read our blog post to learn more about SSCPs and SSPs if you have an implantable/high-risk device or high-risk IVD.  

Manufacturer Requirements for Upcoming EUDAMED Module

The Post-Market Surveillance and Vigilance and Clinical Investigations modules will primarily be used by manufacturers. Let’s take a brief look at how manufacturers can expect to use each module: 

Post-Market Surveillance and Vigilance module
As the name implies, manufacturers will use this module to plan, track, and report their post-market surveillance and vigilance activities. Some information from this module will be publicly available. Serious events will be reported using this module along with the resulting Field Safety Corrective Actions, PMS trend reports, and Periodic Safety Update Reports (PSURs). 

Clinical Investigations module
Manufacturers and sponsors will use this module for all regulatory activities regarding clinical investigations. This includes applications and notifications of clinical investigations and data submissions and processing, such as clinical investigations reports and summaries. Serious adverse events, device deficiencies, and related updates resulting from clinical investigations should also be reported here. Member states and the Commission will use the module to exchange information about clinical investigations, but some will be accessible to the public. 

Market Surveillance module
This module will serve as a communication platform for regulatory authorities. Some information and reports will be accessible to the public.

Register for EUDAMED with MedEnvoy

EUDAMED has been a long time coming. With its gradual rollout nearly complete, many manufacturers still face uncertainty about how to integrate EUDAMED requirements into their existing processes. If you’ve never logged into EUDAMED or are struggling with UDI implementation, MedEnvoy can help.

How MedEnvoy Can Support 

MedEnvoy provides end-to-end support to ensure you and your products are fully prepared: 

• Strategic Guidance – Clarifying your specific obligations under MDR/IVDR and how EUDAMED applies to your organization. 
• Actor Registration – Supporting manufacturers with completing the Actor module registration and obtaining their SRN. 
• UDI & Device Registration – Advising on Basic UDI-DI, UDI-DI, and device data submissions, including assisting with bulk uploads. We can also perform bulk uploads on your behalf. 
• Process Design & Integration – Developing workflows and procedures that ensure consistent EUDAMED reporting and timely updates across your product portfolio. 
• Ongoing Compliance Support – Providing continuous monitoring, updates, and hands-on support so you remain compliant as EUDAMED evolves. 

Learn more About EUDAMED Registration

For more information about the EUDAMED registration and how MedEnvoy can help click here.