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EUDAMED Device Registration Support for Medical Device and IVD Manufacturers

Beyond consulting, Qserve delivers one-stop-shop EUDAMED submissions, including structured UDI strategy, data validation, and XML generation, fully aligned with your regulatory framework and business goals. 

EUDAMED

EUDAMED Device & UDI Registration

The EU MDR (2017/745) and IVDR (2017/746) introduced a strengthened regulatory framework to enhance transparency, traceability, and patient safety. Two legal instruments: Regulation (EU) 2024/1860 and the Commission Decision (EU) 2025/2371 move the European Database on Medical Devices (EUDAMED) from a long-in-the-making database into operational reality. A core element is the implementation of a Unique Device Identification (UDI) system and the registration of device data in EUDAMED. Manufacturers placing devices on the EU market must ensure that their device and UDI information is correctly structured and submitted in the UDI/Device module of EUDAMED.

Following the formal declaration of full functionality of the relevant EUDAMED modules, mandatory use will apply from May 2026, with a 6-month transitional period for devices already placed on the market. Although voluntary registration has been possible, manufacturers are advised to prepare early, as data interdependencies, structuring, and linkage require careful planning.

Qserve supports manufacturers end-to-end with EUDAMED upload using XML methodology. Qserve uses very informative excel templates that can be used to enter the data in a structured way. With strong regulatory knowledge on what is needed for EUDAMED and how it relates to requirements, we also offer support in the structuring of data.

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EUDAMED XML Accepted (2)
EUDAMED

Our Approach for Long-Term Compliance Assurance

Qserve delivers a structured, end-to-end service for EUDAMED Device and UDI submission, designed to ensure data integrity, traceability, and compliance with data validation requirements from initial onboarding through long-term maintenance. Our support covers initial data structuring, XML generation and submission to EUDAMED, with XSD and business rules validation being part of the process; as well as data updates and device additions, when required. Where needed, we provide additional regulatory and technical support, including UDI assignment strategy, regulatory and UDI requirements driving data input, data sources and extraction, UDI change control, UDI and EUDAMED procedures,  

Our step-by-step process ensures transparency and control:

1. During intake and scoping, we define the number of devices, assess data maturity, and agree on scope and responsibilities.

2. During data preparation, manufacturer populates the data using guided template designed to align with EUDAMED requirements and facilitate proper data structure.

3. Qserve converts the manufacturer’s data into fully EUDAMED-compliant XML, applying rigorous XSD validation and communicating any validation issues that require correction. Once validated, Qserve uploads the XML to EUDAMED, monitor business rule checks, and manage any necessary remediation or resubmission.

Throughout the process, we provide status updates and final confirmation of successful submission.

The model is built to scale. Manufacturers may choose a one-time submission for portfolio onboarding, or request additional support and maintenance when changes occur. This modular structure allows companies to maintain control while ensuring continued compliance as portfolios and regulatory requirements evolve.

Impact
If you have any questions about preparing for the deadline, we are ready to support you!
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Before May 28, 2026: Early Preparation & Data Readiness
Manufacturers should use this period to ensure their UDI and device data are fully prepared for mandatory EUDAMED registration. This includes confirming correct UDI allocations, and ensuring consistency between certificates, technical documentation and labelling. UDI/Device registration data sources should be thoroughly assessed, as data gathering is often more complex and time-consuming than anticipated. Data quality is critical: incomplete, inconsistent, or poorly mapped datasets are a common cause of submission delays and rejection. Companies should also define internal roles and responsibilities, ensure adequate procedures are in place and confirm Actor registration.
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After 28 May: Mandatory Registration, Notified Body Interaction & Compliance
From 28 May 2026 onward, use of the UDI/Device module becomes mandatory. Manufacturers must ensure that new devices are registered in EUDAMED prior to market placement and that already marketed devices are uploaded in accordance with transitional timelines. Ongoing compliance includes timely updates for changes impacting device information and maintaining alignment between EUDAMED data and technical documentation. Notified Bodies are required to upload certificates and verify relevant device information in the NB/Certificates module of EUDAMED. While device registration obligations apply earlier, certificate registration timelines follow later, requiring careful coordination and active data monitoring.
Why Choose Qserve

The Benefits of Engaging Qserve as Your EUDAMED Partner

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No Subscription Lock-Ins, but One-Time Payments

Unlike subscription-based models with recurring license costs regardless of submission activity, our one-time submission pricing lets you pay only when needed, avoiding long-term financial commitments. Costs are clearly linked to your number of UDI-DIs, ensuring predictability and scalability. Over a typical three-year period, our model often results in a significantly lower total cost of ownership, while delivering expert regulatory oversight and full support.

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Offering Additional Consulting Service Support

With more than 25 years of regulatory affairs expertise, we go beyond technical execution. We advise on UDI strategy, data sourcing, data alignment and UDI EUDAMED procedures, ensuring your data and processes align with MDR/IVDR expectations. This regulatory depth differentiates us from tool-based providers.

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Support with Technical Validation & Data Validation

We support structured data collection, extraction, and controlled conversion into compliant XML. During the process, both XSD and business rules validation checks are applied to ensure successful data upload.

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Regulatory Compliance Assured

Our approach is designed for long-term regulatory sustainability. We monitor evolving MDR/IVDR requirements and EUDAMED implementation updates, providing confidence in a continuously developing regulatory landscape.

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End-to-End Device Submission Service

From initial scoping to final upload, we deliver a fully managed submission process. Our scalable service model supports both portfolio onboarding and ongoing maintenance, including device updates, certificate changes, and product additions as required.

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No Complex Data Models

Our service removes the need for internal XML expertise, complex data architecture, or expensive platforms. You gain regulatory and technical oversight without investing in additional IT systems or specialised personnel. We simplify compliance while maintaining full regulatory control.

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EUDAMED Device & UDI Registration

FAQ

Can't find the answer you are looking for? Reach out to us, and our team will gladly help you.

Why do I need EUDAMED support?

You need support when placing MDR/IVDR devices on the EU market and preparing to register device and UDI data in EUDAMED. It is especially relevant for first-time registrations, or when internal expertise is limited. Early preparation reduces submission delays due to data rejection and time pressure before mandatory deadlines.

When is EUDAMED registration mandatory under MDR/IVDR?

Use of the UDI/Device module becomes mandatory from May 2026. Manufacturers placing MDR or IVDR devices on the EU market must register their device data. Authorised Representatives and other economic operators also have defined responsibilities within EUDAMED.

How many UDI-DIs can be submitted at once?

EUDAMED allows bulk uploads via XML files. Multiple devices can be submitted in one batch, depending on file structure and system limits. Proper data validation beforehand is critical to avoid batch-wide rejections.

What information is needed for registration?

UDI/Device registration involves over 100 individual data elements to be considered, includung Basic UDI-DI, UDI-DIs, device description, risk class, certificates, economic operator details, EMDN codes, and related regulatory attributes. Consistency with technical documentation and labelling is essential.

Do I need a software platform to register in EUDAMED?

No. While software tools exist, registration can be completed via structured data preparation and XML upload. Our service eliminates the need for internal XML expertise or subscriptions.

Who is responsible for the accuracy of the data submitted to EUDAMED?

The manufacturer remains responsible for the accuracy, completeness, and correctness of the device data submitted to EUDAMED. Qserve supports the process through structured templates, EUDAMED XSD and business rules validation steps, and technical guidance. However, final confirmation of data accuracy and validity rests with the manufacturer.
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