BOOK A MEETING

Whitepaper: A Comprehensive Guide to EU Medical Device Tracking Requirements

Overview: This whitepaper provides an in-depth look at the European Union Medical Device Regulation (EU MDR) and the European Database on Medical Devices (EUDAMED). It covers key compliance milestones, Unique Device Identification (UDI) requirements, common challenges for manufacturers, and practical guidance to prepare. It also outlines best practices for data readiness, system integration, and stakeholder alignment, with visual aids for clarity. Finally, we summarize the value of proactive compliance and how Supply Chain Wizard (SCW) supports end-to-end EU MDR tracking compliance, connectivity to data hubs, and digital transformation.

Book a Meeting Now!

EU MDR and EUDAMED in Context: A Deeper Glance Into The Authority and The Database

EU MDR introduced robust identification and tracking requirements for medical devices. 

EUDAMED – the European Database on Medical Devices – will be central to enforcing these new rules, improving transparency and traceability.

The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) is a comprehensive regulatory framework that replaced the earlier Medical Device Directive (MDD) in May 2021. MDR significantly strengthens requirements for medical device safety, post-market surveillance (PMS), and traceability, including the introduction of the Unique Device Identification (UDI) system and the creation of EUDAMED. In short, MDR and EUDAMED aim to enhance patient safety and harmonize device oversight across all EU member states.

EUDAMED – the European Database on Medical Devices – is a secure, web-based portal being developed by the European Commission as a central repository for device regulatory information. Its purpose is to integrate various regulatory activities (from actor registrations to device UDI data, certifications, vigilance reports, and clinical investigations) into one pan-European system. By doing so, EUDAMED will improve transparency (through public access to certain information) and enable better traceability of devices throughout their lifecycle. For example, once fully functional, the public will be able to search EUDAMED for information about specific devices, their manufacturers, certificates, along with parts of post-market vigilance data such as Field Safety Notices. 

EUDAMED is composed of six interconnected modules, each focusing on a distinct aspect of compliance:

  • Actor Registration: Registration of Supervising Entities (European Commission, Competent Authorities, Designating Bodies, and Notified Bodies) and Economic Operators (Manufacturers, Authorized Representatives, Importers, System/ Procedure Pack Producer).

  • UDI/Device Registration: Submission of device identification data (including UDI) for each product.

  • Notified Bodies & Certificates: Details of CE certificates issued by Notified Bodies

  • Clinical Investigations/Performance Studies: Data on clinical trials for devices (especially high-risk ones).

  • Vigilance and Post-Market Surveillance: Reporting of serious incidents and field safety corrective actions (FSCA)

  • Market Surveillance: Information on enforcement actions by regulators.

Not all modules are operational yet. As of 2025, some modules (like Actor Registration, UDI/Device Registration and Notified Bodies and Certificates modules) are available on a voluntary basis, while others (Vigilance and Post-Market Surveillance, Market Surveillance, Clinical Investigations and Performance Studies) remain under development. EUDAMED’s full functionality has been delayed multiple times, but it remains a cornerstone of the MDR regime, manufacturers are still expected to comply with MDR requirements even before EUDAMED is fully live. This often means using transition period solutions (such as national device registries for certain countries) for vigilance and device registration until EUDAMED becomes mandatory. Despite these transitional challenges, EUDAMED’s importance is clear: It will be the primary platform to submit and access compliance data, and the UDI system will be the key to unlocking device information in that database. In short, if you manufacture or distribute medical devices in Europe, understanding MDR and preparing for EUDAMED is not just about avoiding regulatory issues, it’s about ensuring patient safety, maintaining market access, and streamlining your operations in a more transparent supply chain.

Timeline and Key Milestones for EU MDR and EUDAMED

Understanding the regulatory timeline helps manufacturers anticipate what needs to happen by when. Below we outline the evolution of EU Medical Device Regulations and the schedule of UDI and EUDAMED implementation milestones.

Evolution of EU Medical Device Regulations (1990–2025)

  • 1990s – 2000s: Directives Lay the Groundwork: The first Medical Device Directive (MDD 93/42/EEC) took effect in the 1990s, introducing essential requirements and the CE marking system for devices. It established some traceability and vigilance procedures – for example, defining Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN) in later amendments – but oversight remained somewhat fragmented across EU member states. Additional directives like the Active Implantable Medical Devices Directive (AIMDD) addressed specific high-risk device types (e.g. pacemakers) with traceability needs. However, under the old directives, no unified EU-wide database or standardized tracking system existed, leading to variances in how countries managed device information.

  • 2017: EU MDR Adopted: In response to technological advances and some high-profile device safety issues, the EU adopted the new Medical Device Regulation in 2017, with a transition period until May 26, 2021 for full application. MDR 2017/745 represented the first comprehensive overhaul of EU device rules in decades. It replaced the MDD and AIMDD and introduced stricter requirements for clinical evidence, PMS, and traceability, including the requirement for Unique Device Identifiers on device labels and the creation of EUDAMED. MDR’s goal was a unified, rigorous standard across all EU countries, closing regulatory gaps and enhancing patient safety.

  • 2020–2021: EUDAMED Development and Partial Launch: EUDAMED, mandated by the MDR (Article 33), was envisioned to go live by 2020. Development delays pushed this out. The first module (Actor Registration) became operational on a voluntary basis around late 2020. This allowed manufacturers and other actors to start registering and obtaining a Single Registration Number (SRN). Since then, technical development has continued on the remaining modules. As of mid-2025, three modules are active (Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates) on a voluntary basis, and three modules are still pending (Vigilance, Market Surveillance, Clinical Investigations). An independent audit of the completed modules is expected by late 2025, after which the European Commission can formally declare EUDAMED fully functional.

  • 2025–2026: Expected Go-Live and Mandatory Use of EUDAMED: According to the latest timeline, the Commission aims to have the core modules of EUDAMED ready and audited by mid to late 2025. Once the system is declared functional (through publication in the Official Journal of the EU), a six-month countdown begins. EUDAMED’s use will become mandatory 6 months after the official notification of full functionality. If notification comes by Q3 2025, that implies mandatory use of the Actor registration, UDI/Devices, Certificates, and Market Surveillance modules by Q1 2026.The Vigilance module is expected to follow with mandatory use by late 2026, after a separate audit.The final piece, the Clinical Investigations module, is slated for 2026–2027 development and will be audited along with the rest once ready.In summary, 2025–2026 is when EUDAMED stops being optional and becomes an enforced reality – all manufacturers will need to have their data in the database within that timeframe to place devices on the EU market.

  • 2027 and Beyond: By 2027, the vision is to have all six modules fully operational. Some industry analysis even projects that certain device registration and certificate data might have extended transitional timelines (e.g. compliance for those modules by 2027–2029).However, the European Commission has urged industry not to count on further delays. Companies that procrastinated in the past now face an accelerated timeline – meaning now is the time to get on board with EUDAMED, well ahead of any hard deadlines. Being proactive will not only ensure compliance but also confer competitive advantages.

UDI Implementation Deadlines (2021–2027)

In addition to EUDAMED’s rollout, the MDR introduced a phased implementation of Unique Device Identification (UDI) on product labeling and, for certain devices, direct part marking. The compliance dates depend on device class (risk level):

  • May 26, 2021: UDI marking became mandatory on the labels of Class III (highest risk) devices and implantable devices. From this date, the highest-risk devices had to bear a UDI carrier (barcode or RFID) on their packaging, and manufacturers needed to start assigning UDIs to these products.

  • May 26, 2023: UDI carrier requirement extended to Class IIa and IIb devices (moderate/high risk). Also, for reusable Class III and implantable devices, direct marking of the device itself with a UDI became required (if the device is intended to be reprocessed and reused). This direct part marking ensures traceability even when such devices are separated from their packaging.

  • May 26, 2025: UDI carrier requirement applies to Class I devices (lowest risk), meaning even low-risk devices and general supplies must have UDI barcodes on their labels by this date. In addition, direct marking for reusable devices extends to Class IIa and IIb devices (moderate risk reusables) by 2025.

  • May 26, 2027: Class I reusable devices must bear direct UDI markings on the device itself by this date. This is the final milestone in the UDI implementation timeline, ensuring even the lowest-risk reusable tools have permanent identifiers.

These staggered deadlines gave manufacturers time to implement UDI across all product classes. By 2027, every medical device on the EU market should carry a UDI (on its label at minimum, and on the device itself if reusable). Compliance with these dates is critical – if a device is required to have a UDI and doesn’t, it cannot legally be placed on the EU market after the deadline. The UDI system is also fundamental to EUDAMED: Manufacturers must upload UDI data for their devices into the database (via the UDI/Device Registration module). Regulators and healthcare providers will use these identifiers to track devices in the field, so meeting the UDI deadlines has been a top priority for regulatory compliance teams since 2021.

Schedule A Consultation

Understanding UDI: Key Requirements (Basic UDI-DI, UDI-DI, UDI-PI)

One of the core components of MDR’s tracking requirements is the Unique Device Identification (UDI) system. Every device (with few exceptions) must be assigned a UDI, which enables unambiguous identification of that product in databases and across the supply chain. A UDI is composed of two main parts: a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI). Additionally, the MDR introduces the concept of a Basic UDI-DI, which groups related devices. Below we explain these terms in practical terms:

  • Basic UDI-DI: This is a primary identifier for a family of devices that share the same intended purpose, risk class, and essential design/manufacturing characteristics. Think of it as a model or family ID under which all variations of a device are grouped. The Basic UDI-DI is used for regulatory purposes in EUDAMED – it is the key that links all records for devices in the same family. Importantly, the Basic UDI-DI is not shown on any device label or packaging. Instead, manufacturers must include it in documents like the EU Declaration of Conformity, technical documentation, certificates from Notified Bodies, Summary of Safety and Clinical Performance (SSCP), Free Sales Certificates, and in incident reports. In the EU system, a Basic UDI-DI is often implemented as a Global Model Number (GMN) when using the GS1 issuing agency standard. It serves to group all UDI-DIs (see below) that belong to the same device family. Every Basic UDI-DI must be associated with at least one actual UDI-DI code.

  • UDI-DI (Device Identifier): This is the specific code that identifies a single device model or version and its package configuration. The UDI-DI is what most people think of as the “UDI number” – it will appear on the device’s label and packaging in human-readable form and in machine-readable form (such as scannable barcode/QR code). The UDI-DI is unique to a particular product and package level. For example, a surgical scalpel of a certain model in a box of 10 might have one UDI-DI, while a single scalpel sold individually would have a different UDI-DI (because the package configuration differs). Each UDI-DI is associated with one and only one Basic UDI-DI (i.e., it belongs to a single device family). In practice, when using the GS1 standard, the UDI-DI is usually a GTIN (Global Trade Item Number) – a 14-digit numeric code familiar from retail barcodes. Other issuing agencies use their own formats, but all are globally unique. The UDI-DI is the key that opens the door to specific information about that device in EUDAMED (and it’s also used in other databases like the U.S. FDA’s GUDID). It answers the question: “What device is this?” at the model/package level.

  • UDI-PI (Production Identifier): This component provides batch or item-specific information about the device’s production. While the UDI-DI identifies the model, the UDI-PI identifies the instance (or batch) of that model. The UDI-PI typically includes one or more of the following, as applicable: lot/batch number, serial number, software identification, manufacturing date, and/or expiration date. For example, for a lot-tracked device, the UDI-PI might be the lot number and expiration date; for an implantable with a serial number, the UDI-PI would include that serial. The combination of the UDI-DI and UDI-PI together forms the full UDI that gets encoded in the barcode label. The UDI-PI ensures traceability of specific lots or items, which is crucial for recalls and post-market safety actions.

In summary: Basic UDI-DI groups device versions at the family level, UDI-DI identifies the specific device model, including specific packaging configuration, and UDI-PI identifies the specific batch or unit of that model. If we analogize to a book: Basic UDI-DI is like a book series title, UDI-DI is the ISBN for a particular book edition, and UDI-PI is like the print run number or copy number of that edition.

UDI Carrier: MDR requires that the UDI (UDI-DI + UDI-PI) be presented on device labels and packaging in both human-readable (plain text) and machine-readable forms. The machine-readable form is typically a barcode or QR code (Automated Identification for Data Capture-AIDC technology), and it encodes both the UDI-DI and the applicable UDI-PI elements. Acceptable UDI carrier formats include a 1D linear barcode, 2D DataMatrix or QR code, or RFID tag, as long as it can be read by standard scanners. The human-readable interpretation (HRI) is the printed text above/below/beside the barcode that people can read if needed. Manufacturers must ensure the UDI information is correctly carried on the label at every level of packaging (unit pack, multi-pack, shipper, etc., each with its own UDI-DI).

Accredited Issuing Agencies: Companies do not invent UDIs from scratch; they generate UDIs according to the coding standards provided by one of the designated issuing agencies. The European Commission has designated four issuing entities for UDIs: GS1, HIBCC, ICCBBA, and IFA GmbH. Manufacturers can choose one of these agencies and follow their standards to generate UDI-DIs and Basic UDI-DIs. For instance, GS1 provides the GTIN (UDI-DI) and GMN (Basic UDI-DI) structures. Regardless of the agency used, all UDIs must conform to ISO/IEC formatting standards and ensure uniqueness worldwide. This system also aligns with the UDI requirements of other regulators (like the U.S. FDA), facilitating global traceability.

Practical implications: Implementing UDI means manufacturers need to update labeling artwork to include barcodes, (assign new codes to legacy products) (Rules with legacy devices are different. This document can be used to extract main information for briefly referring to EUDAMED DI / EUDAMED ID instead of Basic UDI-DI & UDI-DI for legacy devices (Management of Legacy Devices MDR EUDAMED), control UDI data in their IT systems, and upload that data to EUDAMED. It’s a significant data management exercise, but one that ultimately improves supply chain safety – for example, hospitals can scan a device’s barcode and immediately identify it, or regulators can trace which batches are involved in an incident. UDI is the linchpin connecting physical products to digital records in EUDAMED, so getting your UDI data right is fundamental to MDR compliance.

Common Challenges and Gaps Manufacturers Face

Transitioning to EU MDR and preparing for EUDAMED compliance has proven challenging for many device manufacturers. Below are some of the most common hurdles and gaps that organizations encounter:

  • Uncertain Timelines and Fragmented Systems: The repeated delays in EUDAMED’s implementation have created uncertainty. Many companies adopted a “wait and see” approach, only to find that they must now scramble as deadlines approach. Moreover, because EUDAMED isn’t fully functional yet, manufacturers have had to use interim solutions – for example, some EU countries require device info to be submitted to national databases or regulators in the meantime.This fragmentation means duplicate work and complexity: firms might be registering products in multiple places and still need to later consolidate everything into EUDAMED. Not all stakeholders have been clear on what’s required during the transition, causing gaps in compliance. Navigating this evolving landscape has been a top challenge, especially for companies selling in many EU states.

  • Data Volume and Quality Gaps: Implementing UDI and EUDAMED involves managing a large volume of data for each device – from device descriptions, classifications, and certificates to UDI details and linkage to clinical information. Ensuring that every required data field is populated correctly is not trivial. In fact, when companies begin preparing their data for EUDAMED, they often discover significant gaps or inconsistencies. One industry analysis found that on average “60% of required UDI information is missing or misaligned within internal systems” when first attempting EUDAMED submissions. (Should we cite this source as well?) Common issues include missing Basic UDI-DIs, inconsistent formats (e.g., different naming conventions for device models across departments), incorrect device category codes, and incomplete fields (like missing expiration dates for products that have them). Data quality is a real challenge – every data point must be complete, accurate, and consistent across systems. If internal master data is poor, it can lead to rejected submissions or, worse, compliance errors that go unnoticed.

  • Technical and System Readiness: Many manufacturers have had to update or overhaul their IT systems to handle MDR’s tracking requirements. This includes labeling systems (to print UDI barcodes and human-readable info), ERP/MRP systems (to store UDI data attributes for each product), and establishing connections or software for submitting data to EUDAMED. Deciding on the method of EUDAMED data submission is a challenge in itself: smaller companies might plan to input data manually via the web interface, but that’s impractical for large portfolios; others are looking at machine-to-machine (M2M) integration which requires significant IT effort (setting up secure machine credentials, an Access Point for eDelivery, and generating XML submissions). Even the “simpler” bulk upload option (uploading XML files via the web portal) demands that a company format its data exactly to EUDAMED’s specifications. Many firms lack tools or expertise in XML data preparation or in building the interfaces between their databases and EUDAMED. Ensuring system integration is ready – or finding a trusted software solution to bridge the gap – is a notable pain point.

  • Resource Constraints and Expertise: Compliance with MDR and EUDAMED is a multi-disciplinary effort, but many organizations underestimated the resources needed. Regulatory affairs teams are often stretched thin managing MDR documentation (clinical evaluations, risk management updates, etc.), leaving little time for the IT-heavy work of EUDAMED data entry. Smaller manufacturers, in particular, may not have dedicated IT or regulatory IT specialists. Training is another gap – staff need to learn new systems (e.g., how to navigate the EUDAMED portal, how to assign UDIs properly). Notified Bodies have also been under pressure, which indirectly affects manufacturers (e.g., delays in getting certificate info). In short, companies face a skills and bandwidth challenge: Who will do all this work and do they know how to do it right?

  • Global and Partner Alignment Issues: For globally active manufacturers, EU MDR compliance is one piece of a larger puzzle. If a company already implemented UDI for the US FDA, they might assume EU UDI is identical – but there are differences (like the Basic UDI-DI, and some different data fields) that can be overlooked. Aligning the EU data with other markets’ data requires careful coordination. Additionally, manufacturers rely on upstream and downstream partners: for instance, contract manufacturers or suppliers might need to provide certain product data, and distributors/importers have obligations to verify devices are registered and compliant. A common gap is failing to communicate and align with these partners. Without clear collaboration, a distributor might accidentally ship an unregistered product, or a contract manufacturer might not implement required label changes in time. Ensuring all stakeholders (internal teams and external partners) are on the same page is often harder than it sounds.

Despite these challenges, the next sections will show that with early planning and the right approach, they can be overcome. The key is to treat compliance not as a last-minute fire drill but as a structured project – one that can even drive improvements in your data and supply chain processes.

Preparation Strategies: How to Get Ready for EUDAMED and MDR Compliance

Given the challenges above, manufacturers must adopt both strategic and tactical measures to ensure they are ready for EUDAMED and ongoing MDR compliance. This section outlines a roadmap to prepare, balancing high-level strategy with actionable steps.

Strategic Preparation: Think Long-Term and Cross-Functionally

  • Integrate Compliance into Your Broader Strategy: Rather than approaching MDR and EUDAMED as a one-time regulatory checkbox, treat them as catalysts for broader improvement. Executive leadership should recognize that investing in compliance infrastructure (data systems, quality processes) will also yield benefits in operational efficiency and supply chain visibility. Viewing compliance as a strategic priority ensures it gets the necessary resources and alignment across departments. A top-down mandate that “MDR compliance is mission-critical” can empower teams to prioritize this work amid competing projects.

  • Form a Cross-Functional Task Force: MDR and EUDAMED touch many parts of the organization – regulatory affairs, quality assurance, IT, supply chain, production, labeling, and even sales (which might need to communicate with distributors). Establish a project team or steering committee with representatives from all key functions. This group should meet regularly to coordinate efforts, track progress on compliance tasks, and troubleshoot issues. For example, IT can update on EUDAMED integration status while RA ensures UDI data accuracy and labeling reports on label change rollout. Cross-functional communication helps avoid blind spots (such as IT setting up a system that doesn’t capture a field RA thought it would, or labeling planning a barcode that IT hasn’t generated data for).

  • Engage External Expertise and Partners: If certain capabilities are lacking in-house, consider involving outside experts early. This could mean hiring a regulatory consultancy experienced in EUDAMED submissions or using solution providers for UDI data management. Similarly, work closely with your Notified Body – they can sometimes provide guidance on expectations (and you’ll need them for certificate data in EUDAMED). Also, engage your supply chain partners: Talk to your critical component suppliers and contract manufacturers about UDI requirements (they may need to add codes to subcomponents or at least not interfere with your coding process), and coordinate with distributors so they know your plan (distributors must check that devices have the required UDI and EU Declaration of Conformity). Early engagement of all stakeholders prevents last-minute surprises and fosters a smoother implementation. Remember, compliance is a team sport – internally and externally.

  • Embrace Digital Tools and Future-Proofing: Use this opportunity to modernize how you handle data. If you’re currently managing product data in spreadsheets or scattered systems, consider implementing a more robust Master Data Management approach or specialized software for regulatory information management. Automation is your friend – manual data entry is error-prone and not scalable. The companies that thrive under MDR will be those who digitize their compliance processes, enabling them to react quickly to future changes (e.g., if regulations update or if similar requirements come in other markets). Additionally, keep an eye on global harmonization. UDI is part of a worldwide trend; aligning your EU data with, say, the U.S. FDA GUDID or the Global Data Synchronization Network (GDSN) will help ensure consistency for your products globally. In short, invest now in systems and integrations that not only meet today’s needs but can adapt to tomorrow’s.

Tactical Steps: A Readiness Checklist for EU MDR & EUDAMED

Now let’s drill down to concrete steps. The following are key actions and best practices that manufacturers should undertake in preparation for mandatory EUDAMED use and ongoing MDR compliance: Need to insert a first step to state “Review regulations and understand your obligations and applicable deadlines- The core data elements to submit to EUDAMED and the level of detail depends on the type of device, its risk class and its applicable legislation. ”

  1. Audit Your Product Data and Documentation: Begin with a gap assessment. For each device, ensure you have all required data fields ready for EUDAMED. This includes UDI elements (Basic UDI-DI, UDI-DI, etc.), device classification info, intended purpose, GMDN/CND codes, dimensions, packaging levels, certificate details, clinical evaluation status, etc. Compare what you have on file to the EUDAMED data dictionary. Identify missing information and inconsistencies. Many firms find that this step uncovers surprises – e.g. legacy products that never had formal descriptions or devices with outdated certificates. It’s far better to find and fix those now than during a rushed submission later. Update your technical documentation as needed so that everything aligns with MDR requirements (which is also necessary for Notified Body audits).

  2. Obtain Basic UDI-DIs and Assign UDIs to All Products: If you haven’t already, coordinate with an issuing agency (GS1, HIBCC, etc.) to generate your Basic UDI-DIs for each device family and the UDI-DIs for each device/version. Maintain a structured list or database of all your products and their identifiers. Make sure this covers every active product (and consider how you will handle legacy devices that may still be on the market under certificates extended by the MDR transition period). Also, implement internal procedures for assigning UDI to new products going forward. This may involve updates to your ERP or PLM (Product Lifecycle Management) systems so that new part numbers trigger the creation of a UDI-DI and Basic UDI-DI as part of the product development process. In short, bake UDI into your product lifecycle.

  3. Update Labels and Direct Marking: For each product category, verify that  labeling and marking is fully compliant with the requirements. If you have reusable devices that require direct marking by May 2027, (like surgical instruments that are reprocessed), ensure you have a plan to mark them (laser etching, engraving, etc.) without damaging the item. Validate that scans of your barcodes (at all levels of packaging) correctly output the UDI data strings. It’s wise to perform this verification in-house before regulators or hospitals do. Maintain a library of label samples as evidence of compliance (this can be useful for your Notified Body or inspectors).

  4. Register in EUDAMED (Actor Registration): If you haven’t done so, use the EUDAMED Actor Registration module (which is live) to register your organization and obtain your Single Registration Number (SRN). This is mandatory for all Manufacturers, Authorized Representatives, System/Procedure Pack Producers andImporters and is a prerequisite to entering device data. The Actor registration process involves filling out company details and getting validation from your national Competent Authority. It can take some time to receive the verification, so start early. Once you have an active SRN, you’re officially in the system and can also use the Playground (training environment) to familiarize yourself with EUDAMED’s interface.

  5. Explore the EUDAMED Playground and Train Your Team: The European Commission provides a Playground (test) environment for EUDAMED where you can practice submitting data without consequences. Take advantage of this. Have your team simulate the submission of a few products: Enter device data, upload an XML, etc. This will highlight any misunderstandings and help users learn the system navigation. Pay attention to data dependencies in EUDAMED’s UI – for example, certain fields become locked once you submit, which means corrections require support intervention.Training in the Playground can prevent errors in the live system. Consider creating internal work instructions or screenshots for reference on how to perform key tasks in EUDAMED. The goal is to ensure your regulatory and IT staff are comfortable with the system before it’s mandatory.

  6. Decide on Data Submission Method and Prepare Accordingly: Evaluate the size of your device portfolio and frequency of changes to decide how you will send data to EUDAMED. The options are:

    • Manual Web Interface: Logging into the EUDAMED web portal and entering device records one by one. This is best for very low volumes (a few devices). It’s not time-efficient for larger companies but requires minimal IT setup.

    • Bulk Upload via XML: EUDAMED allows uploading XML files through the web interface containing multiple device records at once. This is suited for medium volumes (tens to hundreds of devices). To use this, you will need to extract or compose your device data into the specified XML schema. Many companies use an Excel-to-XML conversion or have a tool to generate the file. Test your XML files in the Playground to ensure they meet the schema (any errors will be flagged).

    • Machine-to-Machine (M2M) Connection: This is a direct system integration where your IT system communicates with EUDAMED via a secure eDelivery gateway (machine interface). It’s intended for those with large volumes of data or frequent updates (1000+ records, daily submissions). M2M requires significant preparation: you must set up an Access Point (server) that meets EU specifications, map your database fields to EUDAMED’s, and handle message acknowledgments. If choosing this route, you might work with a vendor experienced in EUDAMED integration. Note that as of 2025, the final specs for M2M were being tested – ensure you have the latest tech requirements from the EC. The investment is higher, but once running, it can automate compliance reporting seamlessly.

  7. Whichever method you choose, start populating your data now. Don’t wait until the last minute to upload everything. The Commission strongly encourages manufacturers to begin voluntary submissions early, to avoid bottlenecks and to iron out issues in advance.Early movers will have the advantage of support availability and will be at the “front of the line” when mandatory deadlines hit.

  8. Validate Data Accuracy and Completeness (Double-Check Before Submission): Before hitting submit, implement a review process for your data. Develop checklists or even scripts to verify that all required fields are present and formatted correctly. For example, ensure that every UDI-DI is the correct length and checksum, every Basic UDI-DI is correctly linked to at least one UDI-DI, the device is assigned to the correct risk class, etc. Also validate that data makes sense across fields (e.g., if a device is marked sterile, then the “sterilization method” field should be populated). Having robust internal processes to validate data for correctness and completeness prior to submission will save a lot of headaches. It’s much easier to correct errors internally than after data has been submitted (or rejected) by EUDAMED. Some firms have found it useful to do peer reviews – e.g., one person enters data, another reviews it – or to use data management tools that flag missing info. Remember that once data is in EUDAMED and the system is live, regulators and possibly the public (for certain data) will see it, so you want it to be accurate.

  9. Stay Informed and Flexible: Finally, keep up with ongoing developments. The regulatory landscape can evolve – for instance, new guidelines from the Medical Device Coordination Group (MDCG) or updates to EUDAMED’s technical documentation are still being released. Subscribe to official channels or industry newsletters for MDR/EUDAMED. Being aware of changes (like an updated timeline, or a new data field added to EUDAMED) will help you adapt quickly. Also, monitor how your processes are working and be prepared to adjust. Maybe you discover that bulk uploads are failing due to a formatting issue – you might need to tweak your data export process. Or if you find your team overwhelmed, consider bringing in additional temporary help or shifting responsibilities. Flexibility is key: The companies that succeed are those that treat compliance as an ongoing process, not a one-time project. In the words of the European Commission, “do not wait” and use the transitional period to your advantage by getting your data in order now.

Conducting internal audits and using checklists is a best practice to ensure all required data is ready and accurate before EUDAMED submission. Thorough preparation and early testing can uncover missing information or system issues while there’s still time to address them.

By following the above steps, manufacturers can greatly reduce the risk of non-compliance and last-minute panic. Preparation not only helps to meet the deadlines but also can reveal opportunities to streamline operations (for example, cleaning up your product data can improve efficiency in other areas like inventory management or global registrations).

In the next section, we will highlight some overarching best practices focusing on data, systems, and people – the three pillars of successful compliance readiness.

Best Practices for Data, Systems, and Stakeholders Alignment

Ensuring EU MDR tracking compliance isn’t just about ticking off tasks – it requires a solid foundation of data quality, well-integrated systems, and coordinated efforts across all stakeholders. Here we discuss best practices in three key areas: data readiness, system integration, and stakeholder alignment.

  1. Data Readiness: High-quality data is the fuel for regulatory compliance. To achieve this:
  • Centralize and Cleanse Your Data: Maintain a single source of truth for device information, such as a centralized database or master data spreadsheet that contains all EUDAMED-required fields for each product. Eliminate duplicate or conflicting records that might exist in different departments. For instance, ensure the product naming is consistent – the name on the label, in the technical file, and in EUDAMED should match to avoid confusion. Use data cleaning tools or scripts to standardize formats (e.g., dates, units of measure).

  • Complete Every Field – and Verify It: For each data element, assign an owner who is responsible for its accuracy. Then systematically fill any gaps identified during your data audit. Once you believe the data is complete, perform spot checks and mock submissions. The goal is to reach a point where you have 100% of required data points complete, accurate, and consistent. Remember the earlier statistic – many companies found around 60% of UDI data was initially missing or wrong. Strive to beat that by proactively finding and correcting issues. A good practice is to run test exports of data in the EUDAMED XML format and validate them before actual submission.

  • Ensure Global Consistency: If you operate in multiple jurisdictions (EU, US, etc.), align your data across them. For example, a device’s UDI-DI used in EUDAMED should be the same GTIN used in the US (assuming the product is identical) – this sounds obvious, but discrepancies do occur, especially if regional teams manage data separately. Consider leveraging global databases like the Global Data Synchronization Network (GDSN) to keep data consistent across your trading partners. This will not only satisfy regulators but also make life easier when hospitals, distributors, or purchasing groups check your product information. Inconsistency can erode trust and cause delays, so aim for one harmonized dataset feeding all needs.

  1. System Integration: Effective system integration ensures that maintaining and reporting compliance data is efficient and error-free. Best practices include:
  • Evaluate Software Solutions: Rather than custom-building everything, look at available compliance management software or modules in your ERP that are designed for UDI and EUDAMED. Many vendors have added MDR features given the demand. The right software can provide user-friendly interfaces to enter data, validation rules to catch mistakes, and one-click generation of EUDAMED submissions. It can also serve as a repository that multiple departments can access. For example, SCW and other providers offer solutions to manage serialization/UDI data and connect with regulatory databases, which might be more cost-effective than a ground-up IT project.

  • Automate Data Flow: Aim to minimize manual data re-entry between systems. If your product data lives in a PLM or ERP system, set up workflows or APIs so that data can flow into your EUDAMED submission tool automatically. This reduces transcription errors. For instance, when a new device is created in PLM, its core data could be pushed to the compliance database, where Regulatory only adds the regulatory-specific fields like GMDN code or Basic UDI-DI. Automation is especially crucial if you plan on machine-to-machine EUDAMED submission. In that case, your system should be generating and sending XML messages directly. Plan the interface early – involve your IT architects to map how data will travel from internal systems to EUDAMED. The complexity of M2M (needing an Access Point, etc.) means you may want a specialized middleware or service to handle it. Some companies might use a third-party gateway service rather than hosting their own.

  • Test Integration in Stages: Don’t wait until everything is built to test. Break the integration project into parts. Test that you can extract the right data in the right format from your system. Then test uploading that data to the Playground environment. If you’re doing M2M, you must test connectivity with the Commission’s servers in advance (there are onboarding procedures to do so). Use dummy data or a subset of real data for trial runs. Early testing will reveal misconfigurations or misinterpretations (for example, maybe your system exports the date format incorrectly). It’s far easier to fix these well before the deadline. Additionally, maintain flexibility if something isn’t working and time is short, have a fallback. For example, if M2M integration faces delays, be ready to use the bulk upload method as a stopgap.

  1. Stakeholder Alignment: Human factors and organizational coordination are often the determining factor in a smooth compliance journey. Best practices here:
  • Leadership Support and Accountability: We touched on executive buy-in earlier; it’s worth emphasizing that visible support from leadership can break down silos. When the C-suite highlights MDR compliance as a priority, middle managers are more likely to allocate their people’s time to it. Establish clear accountability – e.g., designate a program manager or leader for the MDR/EUDAMED readiness program who can coordinate across teams and report progress up to leadership.

  • Communication and Training: Keep all internal stakeholders informed of status, challenges, and changes. Regular briefings or newsletters can help maintain momentum and awareness. Provide targeted training to different groups. For example, train your regulatory staff on the specifics of EUDAMED data entry and UDI assignment rules; train your labeling team on the new label inspection procedures; train your customer service or sales teams on the upcoming changes (they might get questions from hospitals about UDIs or see changes in documentation). A well-informed organization can act cohesively.

  • Engage Supply Chain Partners: As part of stakeholder alignment, include your external partners in the conversation. If you rely on contract manufacturers (CMOs), make sure they understand MDR requirements (in fact, MDR considers many suppliers as legal manufacturers of their components, and they might need their own regulatory compliance). Work with them on how UDIs will be managed for the products they produce for you – for instance, will they place UDI labels under your direction? Will they provide data for your submissions? Clarify roles in agreements. Likewise, talk with distributors: under MDR, importers and distributors have obligations such as verifying that devices are registered in EUDAMED and carry the proper UDI on labeling. It’s mutually beneficial to keep them in the loop: if you’re proactively getting ready, your distributors will feel more confident that they won’t run into supply interruptions due to your non-compliance. Consider providing them with a summary of your compliance plan or even the Basic UDI-DIs and UDI-DIs of products you supply, so they can integrate that into their systems. When everyone – from suppliers to distributors – is aligned, the entire supply chain operates more smoothly and the risk of non-compliant products slipping through is minimized.

  • Leverage Industry Collaboration: A final note on stakeholders: remember that you’re not alone in this. Industry associations, working groups, and conferences/webinars (like the one SCW conducted) are great places to learn and share. Participate in forums to hear how others are solving problems – you might pick up a best practice or a tool recommendation that saves you time and effort. In the rapidly evolving regulatory environment, the community can be an invaluable resource.

Illustration of an integrated approach: All parts of the supply chain – from data systems to human stakeholders – must work in concert for effective compliance. In this schematic, data flows through a central system (ensuring one “source of truth”), while various teams (regulatory, IT, quality, partners) collaborate and check off compliance tasks. Integrating systems and aligning people leads to streamlined, end-to-end compliance.

By focusing on data, systems, and people, manufacturers can build a resilient compliance process. Good data practices reduce errors; strong system integration increases efficiency; and stakeholder alignment ensures everyone is moving in the same direction. This trio underpins not only regulatory success but can also contribute to overall operational excellence.

Conclusion: The Value of Proactive Compliance and SCW’s Support in Your Journey

The EU MDR and EUDAMED requirements represent a significant challenge, but also an opportunity, for the medical device industry. Companies that approach these requirements proactively stand to gain more than just a badge of compliance – they can achieve better data management, improved supply chain traceability, and greater trust from customers and regulators. On the flip side, those who delay action risk supply interruptions, legal penalties, and reputational damage if their devices fall out of regulatory compliance. The writing is on the wall: Being proactive is not just advisable, it’s essential. In other words, compliance can be a competitive advantage.

Let’s summarize the key takeaways from this whitepaper:

  • Know the Landscape: EU MDR has fundamentally raised the bar for device safety and traceability. EUDAMED is the linchpin that will centralize information and enforce these rules across Europe. Understand what EUDAMED is designed to do and how it will impact your processes. Recognize the timeline – core modules likely mandatory by early 2026 – and plan backward from those milestones. Also keep in mind the UDI labeling deadlines (2023, 2025, 2027) which many companies have already been meeting.

  • Master UDI and Data Requirements: Ensure you have a firm grasp of UDI concepts – Basic UDI-DI vs UDI-DI vs UDI-PI – and have assigned these identifiers to your device catalog. UDI isn’t just a label requirement; it’s a data requirement. Your ability to successfully register devices in EUDAMED depends on a complete and correct set of data for each product. Invest the time to build that foundation now.

  • Anticipate Challenges and Address Them: Be honest about where your gaps are – whether in expertise, technology, or data – and seek solutions early. If your team is new to these regulations, get training or external help. If your data is messy, start cleaning it and implementing quality controls. If your IT systems aren’t up to the task, evaluate upgrades or third-party tools. Every challenge has a solution if addressed in advance; it becomes a crisis only if left to the eleventh hour.

  • Implement Best Practices: Use the checklists and practices discussed: Perform thorough data audits, leverage the EUDAMED Playground for testing, choose the right submission method for your needs, automate where possible, and align all parties involved. Particularly, remember that compliance is ongoing – once EUDAMED is live, you’ll need to maintain those records (e.g., update them when you make device changes, add new products, etc.). Set up a sustainable process, not just a one-time project.

  • Think Beyond Compliance – Embrace Digital Transformation: While compliance is mandatory, it also pushes companies toward greater digitalization and integration. Firms can turn the regulatory burden into an impetus for positive change – for example, by establishing a master data governance that not only feeds EUDAMED but also improves internal decision-making. Embracing modern track-and-trace technologies and data analytics can provide real-time visibility into your supply chain, reduce errors, and even lower costs in the long run. Many companies report that after implementing serialization/UDI systems, they gained insights into their distribution networks that they never had before. In essence, compliance can be the stepping stone to a more digitally transformed supply chain.

  • Stay Agile and Informed: Regulations can evolve, and unexpected hurdles can arise. Maintain agility in your compliance approach. If timelines change or new guidelines appear, adjust your plans accordingly. Organizations that bake agility into their compliance culture – for instance, by having regular regulatory intelligence updates and flexible project plans – will handle changes with far less disruption.

Finally, know that you don’t have to navigate this journey alone. This is where Supply Chain Wizard (SCW) comes in as a valuable partner. SCW has been at the forefront of digital supply chain transformation and compliance solutions for over a decade, with deep expertise in serialization, UDI, and track-and-trace programs globally. In the pharmaceutical sector, SCW supported 300+ projects in serialization and digital supply chain initiatives across 40+ countries. We have leveraged that experience to assist medical device manufacturers in tackling MDR requirements.

How SCW supports end-to-end EU MDR tracking compliance:

  • Comprehensive Compliance Solutions: SCW offers a blend of consulting services and digital platforms to address MDR needs. We can assess your current state, help formulate a compliance roadmap, and implement the right tools to execute it. Whether you need a robust data management system for UDI or an integrated solution to connect with EUDAMED (through M2M or other means), our team can deliver a tailored approach. We focus on end-to-end solutions – meaning we don’t just look at one piece (like label printing or data upload) in isolation, but ensure that all parts of the process work together seamlessly.

  • Partner Onboarding & Ecosystem Alignment: One of SCW’s strengths is facilitating collaboration across the supply chain. We understand that for compliance processes to truly work, your partners (suppliers, CMOs, logistics providers, distributors) often need to be involved. SCW can help with the “onboarding” of these partners into your compliance ecosystem – for example, by setting up data exchange processes, providing training, or integrating partner systems where necessary. Our experience in managing large multi-party programs (such as pharmaceutical traceability networks) means we can help create a unified front where all stakeholders are engaged in maintaining compliance and traceability.

  • Digital Transformation & Beyond Compliance: SCW’s mission is not only to check the regulatory boxes but also to unlock value through digital innovation. As we implement solutions for EU MDR tracking, we look for opportunities to improve your operations. This could mean automating manual workflows with our Wizard software tools, implementing dashboards for real-time supply chain visibility, or using analytics on the rich data generated (e.g., to detect supply chain bottlenecks or forecast demand more accurately). By partnering with SCW, companies often find that they achieve compliance and make strides in efficiency and insight – a double win that justifies the investment. SCW’s track-and-trace platforms, for instance, provide real-time monitoring of product movement, which not only satisfies regulatory pedigree requirements but also helps reduce theft, expiry, and inventory issues.

  • Expert Guidance and Ongoing Support: Regulations like MDR can feel like moving targets. SCW’s team of experts stays current with the latest developments and maintains close contact with industry groups and regulators. When you work with us, you gain a knowledgeable ally who can interpret new guidelines, advise on best practices, and adjust strategies as needed. We accompany you through the entire journey – from initial gap analysis to go-live, and then through the maintenance phase. If an issue arises (say a certain UDI record isn’t going through in EUDAMED), our support teams are there to troubleshoot and resolve it. Essentially, we aim to provide peace of mind so you can focus on your core business of developing and selling medical devices.

In conclusion, achieving EU MDR and EUDAMED compliance is a significant undertaking, but it is absolutely attainable with the right approach. By understanding the context and requirements, planning ahead, and leveraging best practices and expert partners, manufacturers can not only comply but also streamline their operations and strengthen their market position. The value of being proactive cannot be overstated – it means less risk, less stress, and more control over your destiny in a regulated market. And as the deadline for EUDAMED mandatory use draws near, the time to act is now.

Supply Chain Wizard is here to help make this complex journey smoother. Together, we can ensure that your organization is not just ready for EUDAMED and MDR, but is using it as a springboard to a more efficient, transparent, and innovative supply chain. By embracing these changes proactively, you protect patients, satisfy regulators, and set your business up for long-term success in the evolving landscape of global healthcare.

For more information about SCW Consultancy Services;

Book a Meeting Now!

For additional detail and help, please contact: 

Mia Van Allen – Managing Partner – mia.vanallen@supplychainwizard.com