EUDAMED Registration Guide 2026: Complete Walkthrough for Medical Device Manufacturers

The European Database on Medical Devices, known as EUDAMED, represents the most ambitious transparency and regulatory data infrastructure project ever undertaken in the medical device sector. Established under Article 33 of Regulation (EU) 2017/745 (the Medical Device Regulation, or MDR) and mirrored in Regulation (EU) 2017/746 (the In Vitro Diagnostic Regulation, or IVDR), EUDAMED is designed to serve as the centralised European platform for the exchange and processing of information relating to medical devices on the EU market. The database consolidates what were previously fragmented national registries and disparate data sources into a single, interconnected system that serves regulators, Notified Bodies, economic operators, and ultimately the public. Understanding EUDAMED is no longer optional for any manufacturer intending to place medical devices on the European market. The database is the regulatory backbone of the MDR ecosystem, and manufacturers who fail to engage with it in a timely and competent manner risk losing market access entirely. This guide provides a thorough, practical walkthrough of what EUDAMED is, what the May 2026 mandatory milestone entails, how the registration process works, and what manufacturers must do now to be prepared.

The legal basis for EUDAMED is established in MDR Article 33, which mandates the European Commission to set up, maintain, and manage the database. The regulation specifies that EUDAMED shall be composed of several interoperable electronic systems that collectively cover the full lifecycle of a medical device, from initial manufacturer registration through to post-market surveillance and vigilance reporting. The purpose is multifaceted: EUDAMED enables competent authorities to carry out their regulatory tasks with access to complete and consistent data, it facilitates transparency by making certain device information publicly available, it supports market surveillance coordination across Member States, and it provides a mechanism for the unique identification and traceability of devices through the Unique Device Identification (UDI) system. The regulation also stipulates that EUDAMED shall be fully functional before the obligations that depend on it become applicable. This conditionality has been the source of significant timeline shifts, as the Commission and Member States have grappled with the technical complexity of delivering a system that meets the regulatory requirements. The original timeline envisaged EUDAMED being fully functional by March 2020, but successive delays pushed the mandatory go-live date. The current confirmed mandatory date for full EUDAMED utilisation is May 2026, a deadline that is now immovable and that manufacturers must treat with the urgency it warrants.

The May 2026 mandatory date marks the point at which all economic operators, specifically manufacturers, authorised representatives, and importers, must fulfil their EUDAMED obligations as described in the MDR and IVDR. Prior to this date, EUDAMED has been operational in a voluntary capacity for certain modules, with Actor Registration and UDI/Device Registration available since their respective launch dates. However, from May 2026, the obligations become legally binding. This means that manufacturers must have completed their Actor Registration, must be submitting UDI-DI data for all devices placed on the EU market, and must be using EUDAMED for the functions specified in the regulation, including the registration of certificates issued by Notified Bodies, the submission of clinical investigation applications where applicable, and the reporting of serious incidents and field safety corrective actions through the vigilance module. The consequences of non-compliance are significant. A manufacturer that has not registered in EUDAMED or that fails to submit required UDI data is in breach of the MDR. Competent authorities have the power to restrict or prohibit the making available of devices on the market, to require corrective actions, and to impose administrative penalties in accordance with national law. For manufacturers who have not yet begun the EUDAMED registration process, the window for orderly preparation is closing rapidly.

EUDAMED is structured around six interconnected modules, each serving a distinct regulatory function but all linked through shared data elements such as the Single Registration Number (SRN) and the Basic UDI-DI. Understanding these six modules is essential for any manufacturer planning its EUDAMED strategy. The first module is Actor Registration, which serves as the gateway to all other EUDAMED functions. Every economic operator, whether manufacturer, authorised representative, importer, or system or procedure pack producer, must register as an actor in EUDAMED and obtain an SRN before they can perform any other action in the system. The SRN is a unique, system-generated identifier that links the actor to all its devices, certificates, and regulatory submissions within EUDAMED. Actor Registration requires the submission of detailed organisational information, including the legal name and address of the entity, the identity of the Person Responsible for Regulatory Compliance (PRRC) as required by MDR Article 15, contact details, and the role of the actor in the supply chain. For manufacturers based outside the EU, registration must be carried out by their authorised representative, who must be established within the EU and who assumes specific legal obligations under MDR Article 11.

The second module is UDI/Device Registration, which is the most data-intensive module and the one that requires the greatest ongoing operational commitment from manufacturers. Under this module, manufacturers must register every device and device variant they place on the EU market by submitting the Basic UDI-DI and associated UDI-DI data elements to EUDAMED. The Basic UDI-DI is the primary identifier of a device model within EUDAMED, while the UDI-DI identifies the specific version or configuration of a device at the packaging level. The data elements that must be submitted for each device include, but are not limited to, the device name and description, the risk class, the applicable conformity assessment procedure, the Notified Body involved (if applicable), the clinical and intended purpose information, MRI compatibility and safety information, whether the device contains medicinal substances, tissues, or blood derivatives, the device status (on the market, no longer placed on the market, etc.), and references to applicable certificates. This module also requires manufacturers to indicate their UDI issuing entity (GS1, HIBCC, ICCBBA, or IFA) and to ensure that the UDI data in EUDAMED is consistent with the UDI data submitted to the relevant UDI database. The volume of data required for a single device registration is substantial, and for manufacturers with large product portfolios, the task of populating EUDAMED with accurate UDI data for every device, every variant, and every packaging level is a significant operational undertaking that must not be underestimated.

The third module covers Notified Bodies and Certificates. This module contains information about designated Notified Bodies, the scope of their designation, and the certificates they have issued. While the primary data entry responsibility for this module lies with Notified Bodies and designating authorities rather than manufacturers, manufacturers interact with this module indirectly because their device registrations must reference the certificates issued for their products. When a Notified Body issues, amends, supplements, suspends, reinstates, or withdraws a certificate, this information is recorded in EUDAMED and linked to the relevant device registrations. Manufacturers should verify that the certificate information displayed in EUDAMED for their devices is accurate and consistent with the physical certificates they hold. Discrepancies between EUDAMED certificate data and the manufacturer's own records can trigger questions from competent authorities during market surveillance activities. The fourth module is Clinical Investigations. This module will be used for the submission of clinical investigation applications and for the reporting of clinical investigation results. Under MDR Articles 62 to 82, sponsors of clinical investigations must submit their applications through EUDAMED, which then facilitates coordinated assessment by the relevant Member States. This module is particularly relevant for manufacturers seeking MDR certification for novel or higher-risk devices where clinical investigation data is required to demonstrate conformity with the General Safety and Performance Requirements.

The fifth module is Vigilance and Post-Market Clinical Follow-Up (PMCF). This module digitalises the serious incident reporting and field safety corrective action (FSCA) reporting processes that are currently handled through national systems. Under the MDR, manufacturers are required to report serious incidents to the competent authority of the Member State where the incident occurred, and to submit field safety notices and periodic summary reports. When the vigilance module becomes mandatory, these reports will be submitted through EUDAMED, enabling cross-border visibility and coordination among competent authorities. The module also covers PMCF study results, creating a link between post-market clinical evidence and the initial clinical evaluation that underpinned the device's conformity assessment. For manufacturers, the transition to EUDAMED-based vigilance reporting requires updates to their quality management system procedures, training of responsible personnel on the EUDAMED interface, and integration of EUDAMED submission workflows with their existing post-market surveillance and complaint handling processes. The sixth module is Market Surveillance. This module is primarily used by competent authorities to record and share information about their market surveillance activities, including inspections, non-compliance findings, and restrictive measures. While manufacturers do not directly enter data into this module, the information recorded here can directly affect them. A non-compliance finding recorded in the market surveillance module is visible to competent authorities across all Member States, which can trigger coordinated enforcement actions.

The step-by-step process for EUDAMED Actor Registration begins with accessing the EUDAMED portal, which is accessible through the European Commission's website. The process involves several distinct stages, and manufacturers should plan for it to take several weeks from initiation to completion, particularly if they are registering for the first time. The first step is to create a user account in the EU Login system (formerly ECAS), which is the authentication gateway for all European Commission IT systems. The designated individual within the manufacturer's organisation must create an EU Login account using their professional email address. Once the EU Login account is established, the user accesses the EUDAMED Actor Registration module and initiates a new actor registration. The system requires the entry of the organisation's legal name, address, and identification numbers (such as VAT number or national registration number). The user must specify the role of the actor (manufacturer, authorised representative, importer, etc.) and provide the details of the Person Responsible for Regulatory Compliance as required by MDR Article 15. For manufacturers outside the EU, the authorised representative initiates the registration on behalf of the manufacturer and must provide the manufacturer's details as well as their own. After the data is entered, the registration is submitted to the competent authority of the Member State where the actor is established (or where the authorised representative is established). The competent authority reviews the registration, may request additional information or corrections, and upon validation, assigns the SRN. This validation step is critical and cannot be bypassed. Manufacturers should factor in the processing time of the competent authority, which varies by Member State but typically ranges from two to six weeks.

Once the Actor Registration is complete and the SRN has been assigned, manufacturers can begin the process of registering their devices in the UDI/Device Registration module. This process requires careful preparation, as the data submitted to EUDAMED must be accurate, complete, and consistent with the information in the device's technical documentation and on its label. The first step is to create the Basic UDI-DI record for each device model. The Basic UDI-DI is not a physical identifier that appears on the device label; it is a data carrier identifier within EUDAMED that groups all UDI-DIs (packaging-level identifiers) for a given device model. The manufacturer must select their UDI issuing entity and enter the Basic UDI-DI code, which should already have been obtained from the issuing entity. For each Basic UDI-DI, the manufacturer then enters the required data elements: device name, description, risk classification, intended purpose, and the various Boolean and coded fields that describe the device's characteristics. The manufacturer must also link the device registration to the relevant certificate in EUDAMED (for devices requiring Notified Body involvement) and to the SRN of the authorised representative (for non-EU manufacturers). After the Basic UDI-DI record is created, the manufacturer registers each individual UDI-DI under that Basic UDI-DI. Each UDI-DI represents a specific packaging configuration and carries its own set of data elements, including the unit of use identifier, package quantity, and production identifiers. The data for each UDI-DI must be consistent with what is submitted to the UDI database of the relevant issuing entity (GUDID for GS1, etc.). EUDAMED performs automated validation checks on the submitted data, and registrations that fail validation cannot be completed until the errors are corrected.

Data quality is one of the most challenging aspects of EUDAMED compliance, and it is the area where manufacturers most frequently encounter difficulties. EUDAMED enforces a set of business rules and validation checks that verify the consistency, completeness, and format of submitted data. Common validation failures include mismatches between the risk class declared in the device registration and the conformity assessment procedure indicated, inconsistencies between the device description in EUDAMED and the description on the Declaration of Conformity, missing mandatory fields (particularly for higher-risk devices where more data elements are required), incorrect formatting of UDI codes, and failure to link device registrations to valid certificates. Beyond automated validation, competent authorities also perform manual reviews of EUDAMED data as part of their market surveillance activities. Authorities have reported finding significant data quality issues in early EUDAMED submissions, including generic or uninformative device descriptions, incorrect classification, and incomplete intended purpose statements. Manufacturers should treat EUDAMED data entry with the same rigour they apply to their technical documentation. The information in EUDAMED is, in effect, a public-facing summary of the device's regulatory status, and inaccuracies or omissions can prompt regulatory scrutiny. Best practice is to establish a formal EUDAMED data management procedure within the QMS that defines responsibilities for data entry, review, and maintenance, and that specifies the data sources (technical file, labelling, Declaration of Conformity) from which EUDAMED fields should be populated.

Integration of EUDAMED processes with the manufacturer's existing quality management system is not merely a best practice but a practical necessity. The MDR and EN ISO 13485:2016 both require that regulatory activities be controlled within the QMS. Specifically, the QMS must include procedures for device registration and UDI management, for vigilance reporting, and for post-market surveillance. With EUDAMED becoming the mandatory platform for these activities, the QMS must be updated to reflect EUDAMED-specific workflows. This includes defining who within the organisation is authorised to submit data to EUDAMED, what review and approval steps are required before data is submitted, how EUDAMED data is kept synchronised with the technical documentation and labelling, and how changes to device registrations (e.g., when a device is modified, when a certificate is renewed, or when a device is withdrawn from the market) are managed. Manufacturers should also consider the implications for their document control procedures. EUDAMED submissions create a regulatory record that must be traceable and auditable. The QMS should specify how EUDAMED submission confirmations and SRN/UDI records are stored and linked to the relevant device technical files. For manufacturers with ISO 13485-certified QMS, the EUDAMED integration should be addressed during internal audits and management reviews to ensure ongoing compliance. Notified Bodies are increasingly examining EUDAMED readiness as part of their conformity assessment audits, and a manufacturer that cannot demonstrate a systematic approach to EUDAMED data management is likely to receive audit findings.

One of the most common pitfalls manufacturers encounter during EUDAMED registration is underestimating the complexity and resource requirements of the process. For a manufacturer with a portfolio of even 50 devices, each with multiple packaging configurations, the number of individual EUDAMED records that must be created, reviewed, and maintained can run into the hundreds. Each record requires accurate data drawn from the technical file, and any change to the device, its classification, its labelling, or its certificate triggers a corresponding update in EUDAMED. Manufacturers who approach EUDAMED as a one-time data entry exercise rather than an ongoing data management responsibility will quickly fall behind. Another frequent mistake is delegating EUDAMED responsibility to individuals who lack regulatory expertise. EUDAMED data entry requires a working knowledge of MDR classification rules, UDI structure, conformity assessment procedures, and the content of the technical documentation. Data entry errors made by personnel without this knowledge are difficult to detect and can result in regulatory non-compliance. A third common pitfall is failing to coordinate EUDAMED registration with the authorised representative. For non-EU manufacturers, the authorised representative plays a critical role in the EUDAMED process, both as the entity that initiates the manufacturer's registration and as a required link in the device registration chain. Misalignment between the manufacturer and the authorised representative, whether on data content, timing, or responsibilities, is a frequent source of registration delays and errors.

Additional pitfalls include neglecting to update EUDAMED records when changes occur. The MDR requires manufacturers to keep their EUDAMED data current. This means that when a new certificate is issued, when a device is reclassified, when a field safety corrective action is implemented, or when a device is no longer placed on the market, the corresponding EUDAMED records must be updated within the timelines specified in the regulation. Manufacturers who lack a systematic process for monitoring and implementing these updates risk having stale or inaccurate data in EUDAMED, which is a compliance finding in itself and can trigger broader market surveillance scrutiny. Another overlooked issue is the handling of legacy devices during the transition period. Devices that are on the market under MDD or AIMDD certificates and that are transitioning to MDR certification have specific EUDAMED requirements. Manufacturers must ensure that these devices are appropriately reflected in EUDAMED, including their current regulatory status and any applicable transition provisions. The interplay between legacy certificates, MDR applications in progress, and EUDAMED data requirements is complex, and manufacturers should seek regulatory guidance if they are uncertain about how to handle specific scenarios.

For manufacturers operating in Switzerland, the relationship between EUDAMED and the Swiss regulatory framework deserves particular attention. Switzerland is not an EU Member State and is not directly subject to the MDR. However, Switzerland revised its own medical device legislation with the new Ordinance on Medical Devices (MedDO), which entered into force on 26 May 2021 and substantially aligns Swiss law with the EU MDR. Under the MedDO, Swissmedic, the Swiss Agency for Therapeutic Products, operates its own device registration system. Switzerland had been developing a national equivalent to EUDAMED, commonly referred to as the Swiss database for medical devices, to support the registration and identification of devices placed on the Swiss market. Manufacturers who place devices on both the EU and Swiss markets must navigate both systems, which means maintaining registrations in EUDAMED (for EU market access) and complying with Swissmedic registration requirements (for Swiss market access). While the data requirements are substantially aligned due to the regulatory convergence between the MDR and MedDO, they are not identical, and manufacturers must be aware of the differences. For example, Switzerland requires a Swiss Authorised Representative for non-Swiss manufacturers, which is a separate role from the EU Authorised Representative. The UDI requirements are also aligned but administered independently. Manufacturers should establish parallel registration workflows for EU and Swiss market access and ensure that their QMS addresses both sets of obligations.

The mutual recognition agreement (MRA) between Switzerland and the EU on medical devices, which historically facilitated market access, has not been updated to cover the MDR. This means that the simplified procedures that previously allowed Swiss manufacturers to access the EU market (and vice versa) without additional requirements are no longer in effect for devices under the MDR. Swiss manufacturers exporting to the EU must now appoint an EU Authorised Representative, obtain MDR certification from an EU-designated Notified Body, and comply fully with EUDAMED obligations, just as any other non-EU manufacturer would. Conversely, EU manufacturers placing devices on the Swiss market must comply with Swissmedic requirements, including appointing a Swiss Authorised Representative. This dual compliance burden is a significant consideration for manufacturers in Switzerland and the broader DACH region, and it underscores the importance of having a clear regulatory strategy that addresses both jurisdictions from the outset. Manufacturers who are already registered in EUDAMED for EU market access have a head start in terms of data preparation, as much of the device information required by Swissmedic mirrors the EUDAMED data elements. However, the administrative processes and submission platforms are separate, and manufacturers must manage both independently.

The UDI-DI submission requirements in EUDAMED warrant detailed examination, as UDI compliance is one of the most operationally demanding aspects of the MDR. The UDI system, as defined in MDR Article 27 and Annex VI Part C, requires that every medical device placed on the EU market carries a UDI on its label and on all higher levels of packaging. The UDI consists of two components: the UDI-DI (Device Identifier), which identifies the specific device and its manufacturer, and the UDI-PI (Production Identifier), which identifies the unit of production, including elements such as lot number, serial number, expiry date, and manufacturing date. The UDI-DI must be submitted to the EUDAMED UDI/Device Registration module and to the UDI database operated by the manufacturer's chosen issuing entity. In EUDAMED, the UDI-DI data submission includes all the data elements specified in Annex VI Part B, which encompass the device's identifying, commercial, and regulatory characteristics. The submission must accurately reflect the device as it is placed on the market, including all applicable variants and packaging configurations. For devices with multiple levels of packaging (e.g., unit of use, inner box, outer box, shipping container), each packaging level requires its own UDI-DI and corresponding EUDAMED registration. The implementation timeline for UDI obligations has been staggered by device class, with Class III and implantable devices subject to the earliest deadlines and Class I devices subject to later deadlines. However, with the May 2026 EUDAMED mandatory date, all manufacturers should be working towards full UDI compliance regardless of device class.

For manufacturers who have not yet begun the EUDAMED registration process, the situation is urgent but not irrecoverable. The key is to act immediately and to approach the process in a structured and prioritised manner. The recommended timeline for a manufacturer starting from zero is as follows. In the first two weeks, the manufacturer should conduct an internal inventory of all devices placed on the EU market, including their classification, applicable certificates, and current UDI status. This inventory forms the foundation for all subsequent EUDAMED activities. In parallel, the manufacturer should identify and assign the internal EUDAMED responsible person or team, ensuring that the individuals have the necessary regulatory knowledge and system access. During weeks three and four, the manufacturer should initiate the Actor Registration process in EUDAMED. This requires having an EU Login account, preparing the organisational data, and submitting the registration to the relevant competent authority. The manufacturer should also contact their authorised representative (if applicable) to coordinate the registration process. From weeks five through twelve, the manufacturer should focus on preparing and submitting device registrations in the UDI/Device Registration module. This is the most time-consuming phase and requires extracting data from technical files, labels, and Declarations of Conformity for every device in the portfolio. Manufacturers should prioritise higher-risk devices (Class III, Class IIb) and devices with the highest commercial importance. From weeks twelve through twenty, the manufacturer should address the remaining device registrations, verify the accuracy of all submitted data, and establish the ongoing data management procedures within the QMS. This timeline assumes a moderately sized portfolio and a dedicated regulatory affairs resource. Manufacturers with larger portfolios or limited internal resources should plan for a longer timeline or engage external regulatory support.

Practical preparation for EUDAMED compliance extends beyond the registration process itself. Manufacturers should ensure that their technical documentation is in order, as EUDAMED data must be consistent with the technical file. Any discrepancies between the device information in EUDAMED and the information in the technical documentation, the Declaration of Conformity, or the device labelling will be flagged during competent authority reviews and Notified Body audits. Key documents to review and align include the risk classification rationale (ensuring the class declared in EUDAMED matches the classification documented in the technical file), the intended purpose statement (ensuring the EUDAMED description is consistent with the intended purpose in the technical documentation and on the IFU), the certificate details (ensuring the Notified Body number, certificate number, and scope match between EUDAMED and the physical certificate), and the UDI assignments (ensuring that the UDI-DIs registered in EUDAMED match those on the device labels and in the UDI database). Manufacturers should also review their post-market surveillance procedures to prepare for the transition to EUDAMED-based vigilance reporting. This means familiarising responsible personnel with the vigilance module interface, updating procedural documents to reference EUDAMED reporting workflows, and establishing timelines for incident reporting that account for the EUDAMED submission process.

The EUDAMED system also has implications for the manufacturer's supply chain and commercial operations. Distributors and importers have their own EUDAMED obligations under the MDR, including the requirement to verify that the manufacturer and the device are registered in EUDAMED before making a device available on the market. This means that a manufacturer's failure to register in EUDAMED does not only affect the manufacturer itself but can also block the distribution chain. Distributors and importers who place non-registered devices on the market are themselves in breach of the MDR. Manufacturers should proactively communicate their EUDAMED registration status to their distribution partners and ensure that SRN numbers and Basic UDI-DIs are shared with the relevant parties in the supply chain. For manufacturers who operate through multiple authorised representatives in different Member States or who have complex distribution networks, the coordination of EUDAMED data across the supply chain requires a systematic approach and clear contractual arrangements.

From a data privacy perspective, manufacturers should be aware that certain information submitted to EUDAMED is publicly accessible. The MDR specifies that information about registered devices, including the device name, manufacturer name, Basic UDI-DI, risk class, and certificate status, is made available to the public through the EUDAMED public website. This transparency is a core objective of the regulation, as it enables healthcare professionals, patients, and other stakeholders to access reliable information about the devices on the market. However, manufacturers should review the data they submit to EUDAMED with this public visibility in mind. Commercially sensitive information should not be included in free-text fields, and device descriptions should be professionally drafted and accurate, as they will be publicly associated with the manufacturer's brand. Competent authorities, Notified Bodies, and the Commission have access to additional non-public data within EUDAMED, including vigilance reports and market surveillance findings. The EUDAMED data protection framework is governed by EU data protection legislation, but manufacturers should ensure that their own data management practices comply with both EUDAMED requirements and applicable privacy regulations, including the GDPR.

The interplay between EUDAMED and the broader MDR compliance ecosystem should not be overlooked. EUDAMED is not an isolated IT system; it is an integral part of the regulatory framework that connects manufacturers, Notified Bodies, competent authorities, and the European Commission. Data entered in EUDAMED feeds into regulatory decision-making processes, market surveillance activities, and public transparency mechanisms. The quality and timeliness of EUDAMED data directly affects the manufacturer's regulatory standing. A manufacturer with complete, accurate, and current EUDAMED data demonstrates regulatory maturity and commitment to compliance. Conversely, a manufacturer with incomplete, inaccurate, or outdated EUDAMED data signals potential compliance weaknesses that may attract increased regulatory scrutiny. As EUDAMED matures and competent authorities develop more sophisticated data analysis capabilities, the database will increasingly be used as a tool for risk-based market surveillance, where data patterns and anomalies in EUDAMED trigger targeted inspections and enforcement actions. Manufacturers who invest in robust EUDAMED data management now will be better positioned to navigate this evolving regulatory landscape.

EUDAMED also serves as a critical tool for post-market surveillance coordination across the European Union. Once the vigilance module is fully operational and mandatory, all serious incident reports and field safety corrective actions will be visible to competent authorities in all Member States simultaneously. This represents a fundamental shift from the current system, where incident reports are submitted to individual Member States and cross-border information sharing depends on manual coordination between authorities. For manufacturers, this means that a serious incident reported in one Member State will be immediately visible to authorities in all other Member States where the device is marketed. Manufacturers must ensure that their vigilance reporting is consistent, timely, and comprehensive, as any gaps or inconsistencies will be visible across the entire European regulatory network. The PMCF component of the vigilance module will also enable authorities to review the post-market clinical evidence that manufacturers are generating, providing an additional layer of oversight for the ongoing safety and performance of devices on the market.

For organisations with complex device portfolios spanning multiple device classes, therapeutic areas, and market configurations, a phased EUDAMED implementation strategy is advisable. Rather than attempting to register all devices simultaneously, manufacturers should prioritise their EUDAMED activities based on a combination of regulatory risk and commercial importance. Class III devices and Class IIb implantable devices should be registered first, as these are subject to the most stringent regulatory oversight and are most likely to be the subject of competent authority review. Devices that are the subject of ongoing Notified Body conformity assessments should also be prioritised, as Notified Bodies increasingly expect to see EUDAMED registration as part of the certification process. Legacy devices that are on the market under transition provisions should be registered with their current regulatory status clearly indicated. New devices entering the market should have EUDAMED registration integrated into the product launch process from the outset. Throughout this phased implementation, the manufacturer should maintain a master device register that tracks the EUDAMED status of each device and that serves as the single source of truth for the organisation's EUDAMED compliance posture.

The technical infrastructure for EUDAMED interaction also deserves consideration. While EUDAMED provides a web-based user interface for manual data entry, manufacturers with large device portfolios may benefit from using the EUDAMED system-to-system (S2S) interface, which allows for automated data exchange between the manufacturer's internal systems and EUDAMED. The S2S interface uses XML-based messaging and requires technical implementation, but it can significantly reduce the manual effort associated with maintaining EUDAMED registrations for large portfolios. Manufacturers considering the S2S approach should engage their IT teams early in the planning process, as the integration requires development effort, testing, and validation. The European Commission provides technical specifications and test environments for the S2S interface, and manufacturers should take advantage of these resources during their implementation planning. For manufacturers with smaller portfolios, the web-based interface is adequate, but even for manual data entry, the use of standardised data templates and internal checklists can significantly improve efficiency and accuracy.

Swiss MPC supports medical device manufacturers throughout the EUDAMED registration process, from initial readiness assessment and Actor Registration through to complete UDI-DI data submission and ongoing data management. Our regulatory affairs team has hands-on experience with the EUDAMED system across all device classes and can provide targeted support for manufacturers who need to accelerate their EUDAMED compliance ahead of the May 2026 mandatory date. Whether you require a gap analysis of your current EUDAMED readiness, assistance with preparing and submitting device registrations, or guidance on integrating EUDAMED workflows into your quality management system, our consultants work alongside your team to deliver practical, efficient results. For manufacturers who also need to navigate the parallel Swiss registration requirements, our Cham, Switzerland headquarters and deep familiarity with both EU and Swiss regulatory frameworks position us to provide coordinated cross-jurisdictional support. Contact us at info@swissmpc.com or through our website to discuss your EUDAMED readiness.