As EUDAMED implementation progresses and the 28 May 2026 compliance checkpoint approaches, medical device and IVD manufacturers are reassessing how they manage their UDI and device registrations.
EUDAMED offers three primary pathways for submitting device and UDI data, each with distinct trade-offs. Manual data entry via the user interface is the most straightforward option, but it quickly becomes impractical – tedious, time-consuming, and error-prone – making it suitable only for very small portfolios with a handful of devices. At the other end of the spectrum, fully automated machine-to-machine (M2M) integration enables seamless, large-scale data exchange, but demands a sophisticated and costly IT infrastructure that is often beyond the reach or necessity of many manufacturers. Between these extremes lies bulk upload using structured XML files: while it requires an upfront effort to prepare data in the correct format, it allows organisations to efficiently submit medium to large volumes of data. For many companies, XML bulk upload strikes the optimal balance between feasibility and efficiency, offering significant time savings without the complexity and expense of full automation.
XML Bulk Upload Challenges
However, leveraging XML bulk upload effectively comes with its own set of challenges. Data must be carefully structured according to strict and complex XSD schemas, and every submission must pass rigorous validation rules before acceptance. This frequently involves transforming data from commonly used formats – such as Excel spreadsheets – into well-formed XML, ensuring consistency, completeness, and compliance with EUDAMED requirements. Such technical competencies, including schema validation, data mapping, and markup language handling, are rarely core skills within regulatory affairs or submission teams. As a result, many organisations find that outsourcing XML bulk upload preparation and submission can significantly reduce internal burden, minimise errors, and accelerate timelines – freeing up internal resources to focus on strategic regulatory activities rather than technical data processing.
Whilst many data submission services are often based on fixed annual or subscription based models, more flexible 'pay-only-when-needed' models are gaining appeal. Since UDI submission volumes are rarely static, this model offers one-time pricing aligned with actual submission needs, allowing manufacturers to submit, update and expand when required. This approach ensures better alignment between regulatory workload and spend, avoids budgets tied to unused capacity, and provides greater control, transparency, and operational agility. Moreover, it encourages smarter internal planning and improves the integration of regulatory activities into product lifecycle management.
Better Alignment with Product Lifecycle
UDI submissions are inherently tied to the product lifecycle events:
- Initial EU market placement
- Product and regulatory changes
- Certificate renewals
- Portfolio expansions
- Device discontinuations
A flexible pay-only-when-needed model integrates naturally into these milestones. Regulatory costs become part of launch planning, change management, and portfolio strategy.
Flexibility for Different Portfolio Sizes
As outlined earlier, different pathways are best suited to how a manufacturer’s portfolio is structured. Global organisations managing large volumes of UDI-DIs typically have different requirements than mid-sized companies, while start-ups often require more intensive onboarding support. A flexible model that is scalable alongside the business ensures that the service level is aligned with future needs in every scenario:
- Early-stage companies entering the EU market
- Established manufacturers optimising existing portfolios
- Businesses undergoing mergers or acquisitions
- Organisations phasing products in or out
The Bottom Line
Flexible UDI submission pricing is not just about saving money. By matching services to real regulatory activity, organisations can ensure that resources are deployed where they create the most value, avoiding unnecessary effort or unused capacity. This targeted approach also enables smarter budgeting, as submission investments are aligned with actual needs rather than assumptions. At the same time, compliance activities can be strategically aligned with the product lifecycle and overall portfolio strategy, supporting market entry, variations, renewals, and discontinuations in a coordinated and forward-looking manner. Throughout this process, maintaining control over data quality remains essential, especially when leveraging an XML bulk upload effectively Do not hesitate to contact our team if you require EUDAMED submission support.