Top EUDAMED M2M & Domibus Access Point Providers
EUDAMED M2M requires an AS4-compliant eDelivery Access Point. According to European Commission guidance, both sides must be AS4-compliant and Domibus is used on the EUDAMED side<sup><a href='#cite-ap-required'>[1]</a></sup>. You can self-host Domibus + manage PKI/uptime, or use a vendor to provide/host the Access Point and integrations.
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Compare EUDAMED M2M Integration Providers
For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.
EUDAMED Specialists
EUDAMED Specialists provide comprehensive services for EUDAMED compliance, including data submission, software solutions (M2M & Bulk Upload), and expert training. They assist with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
EUDAMED Specialists are dedicated to helping businesses navigate the complexities of the EUDAMED database. They offer a full suite of services designed to ensure compliance with European Commission regulations such as MDR and IVDR, with a mandatory deadline of May 28, 2026. Their offerings include robust software solutions like EudaMed+ and EudaMed Bronze (SaaS) for M2M and bulk data uploads, simplifying the submission process. These tools facilitate UDI data validation, preparation, and automated uploads, including features for UDI DI cloning, version control, and data management. They also support integrations with SwissDaMed and AusUDID. Beyond software, EUDAMED Specialists provide extensive training programs tailored for IT teams, management, and RA/QA professionals. These training sessions cover EUDAMED requirements, data structures, XML, and best practices. Consultancy services are also available for project management, attribute analysis, and developing future EUDAMED management strategies. Furthermore, their EUDAMED Check service offers critical tools for importers and manufacturers to verify UDI DI presence in EUDAMED, obtain certified proof of submissions, and identify missing data. This service helps ensure legal obligations are met and provides valuable competitor analysis capabilities.
Website:
eudamed.com
HQ:
Dublin, Ireland
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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tracekey UDI Manager
tracekey solutions GmbH offers the mytracekey UDI Manager, a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework. They focus on simplifying compliance with EU regulations.
tracekey solutions GmbH provides the mytracekey UDI Manager, a comprehensive software solution tailored for medical device manufacturers navigating the complexities of UDI (Unique Device Identification) registration within the EUDAMED database. Their offering emphasizes simplifying the process of data collection, processing, and pre-validation to ensure compliance with stringent EU regulations. The mytracekey UDI Manager assists manufacturers in pre-validating their master data before submission to EUDAMED. This proactive approach helps identify and correct potential errors, such as incorrect formatting, misplaced digits, or missing information, thereby reducing the risk of upload failures and the time-consuming detective work often associated with EUDAMED error messages. The tool supports various upload methods, including manual entry, XML bulk upload, and M2M connections, adapting to different project needs. With a focus on making compliance intuitive and efficient, tracekey solutions GmbH aims to empower companies in the healthcare sector to meet global regulatory requirements without hindering innovation. Their solutions are designed to be scalable and cost-effective, ensuring that regulatory adherence is manageable and precise for each client's specific needs. They are based in Germany, emphasizing transparency and high standards in their services.
Website:
tracekey.com
HQ:
Bochum, DE
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English, German
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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Innovit
Innovit provides cloud-based solutions for EUDAMED and UDI compliance, helping medical device suppliers and healthcare providers manage and validate regulatory data for global compliance and patient safety.
Innovit specializes in simplifying the complex process of managing, validating, and exchanging trusted product data to ensure regulatory compliance. Their solutions are designed to help medical device suppliers and healthcare providers meet stringent global UDI requirements, including EUDAMED and AusUDID mandates. With a focus on product information management and global data syndication, Innovit offers user-friendly, certified GDSN solutions and cloud-based platforms like EUDAMED.cloud. These tools enable organizations to gain visibility into data requirements, train staff, and submit validated data to regulatory agencies efficiently. They also assist in improving product data quality, driving supply chain analytics, and enhancing patient safety. Innovit's expertise extends to navigating the evolving landscape of country-specific UDI regulations, offering a central hub for resources and solutions to achieve worldwide UDI compliance. They empower businesses to take full control of their compliance processes, meet ever-changing deadlines, and address the commercial needs of healthcare providers.
Website:
innovit.com
HQ:
Austin, US
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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tracekey (mytracekey UDI Manager)
tracekey provides RegTech solutions for the Life Science industry, specializing in UDI management for MedTech and Pharma. They offer intelligent, scalable software to ensure compliance with global regulatory requirements.
tracekey solutions GmbH is a German-based company offering RegTech solutions tailored for the Life Science industry, with a strong focus on UDI management for MedTech and Pharma sectors. Their flagship product, mytracekey UDI Manager, helps companies navigate complex global regulatory requirements, ensuring compliance with standards like EUDAMED. They emphasize creating intuitive, efficient, and cost-effective software that simplifies compliance without hindering innovation. tracekey's solutions are designed to be scalable and secure, supporting companies in meeting stringent regulatory demands and enhancing patient safety through improved traceability of medical devices. With a commitment to transparency and high standards, tracekey assists businesses in achieving worldwide serialization compliance and managing UDI data effectively. Their expertise extends to understanding various international regulatory landscapes, including those in the EU and Australia, positioning them as a key partner for life science organizations.
Website:
tracekey.com
HQ:
Bochum, Germany
Languages:
German
Modules:
Actor, UDI/Devices
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Ademico Software
Ademico Software specializes in providing eDelivery AS4 services with Domibus Access Point, enabling seamless M2M integration for EUDAMED, PEPPOL, UDB, and EPREL.
Ademico Software is a dedicated provider of eDelivery AS4 services, with a strong focus on the Domibus Access Point. They facilitate machine-to-machine (M2M) communication for critical platforms such as EUDAMED, PEPPOL, UDB, and EPREL, streamlining data exchange and regulatory compliance. Their solutions are designed to simplify complex integration processes. For EUDAMED, they offer M2M capabilities to register UDI-DI devices efficiently, saving significant time compared to manual registration. Ademico Software also provides access to the PEPPOL network, enabling businesses to send and receive data within e-procurement ecosystems. Ademico Software offers flexible deployment options, including a SaaS Domibus Access Point or on-premises installations. They emphasize robust security and provide support throughout the onboarding process for platforms like EUDAMED, ensuring a smooth and efficient experience for their clients. Their commitment to continuous improvement is driven by client feedback, aiming to enhance their specialized eDelivery AS4 services.
Website:
ademico-software.com
Languages:
English
Modules:
Actor, UDI/Devices
Features:
Access Point, Domibus
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Innovit
Innovit provides cloud-based solutions for managing, validating, and exchanging product data to ensure regulatory compliance, particularly for EUDAMED and UDI requirements in healthcare.
Innovit specializes in simplifying the complex process of managing and validating product data for regulatory compliance, with a strong focus on EUDAMED and UDI requirements in the healthcare and life sciences sectors. Their GDSN.cloud and EUDAMED.cloud solutions empower medical device manufacturers and suppliers to meet stringent global regulations, reduce procurement spend, and improve supply chain analytics. With upcoming deadlines for EUDAMED and Australian AusUDID, Innovit offers tools to gain visibility into data requirements, train staff, and submit validated data. They provide user-friendly, certified GDSN solutions and dedicated platforms to manage, validate, and exchange accurate regulatory data, ensuring compliance with agencies like the FDA and European Commission. Innovit's offerings include Product Information Management, Global Data Syndication Hub, UDI Compliance, and Multi-domain MDM, helping organizations improve data quality, meet UDI data compliance, and drive supply chain efficiencies. They serve Healthcare Providers, Medical Device Suppliers, and GPOs & Distributors, assisting them in navigating evolving country-specific regulations and data sharing requirements.
Website:
innovit.com
HQ:
Austin, US
Languages:
English
Pricing model:
Flat subscription
Modules:
UDI/Devices
Features:
Access Point, Sandbox
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ACKOMAS
ACKOMAS provides automated regulatory compliance solutions for medical device manufacturers, specializing in seamless data synchronization with EUDAMED and GUDID for efficient market access and continuous compliance.
ACKOMAS is a leading provider of regulatory compliance solutions for medical devices, specializing in real-time data synchronization with global databases like EUDAMED, GUDID, and Swissdamed. Their platform simplifies complex regulatory processes, enhances data security, and ensures seamless, scalable compliance, helping manufacturers automate data management and maintain market readiness. With a focus on EUDAMED compliance, ACKOMAS offers solutions that streamline submissions, synchronize regulatory data worldwide, and provide real-time alerts for regulatory changes, minimizing risks and delays. They are trusted by manufacturers seeking control, continuity, and predictability in their compliance efforts, securing investments in technical documentation and certifications. ACKOMAS's expertise extends to UDI implementation, Master UDI-DI requirements, and ensuring data integrity through ALCOA+ principles. They offer tailored solutions, educational resources like guides and webinars, and robust M2M integrations to de-risk EUDAMED projects and ensure long-term operational continuity and market access under MDR/IVDR regulations.
Website:
ackomas.com
HQ:
France
Languages:
French, Italian
Pricing model:
Custom pricing
Modules:
Actor, UDI/Devices, Certificates
Features:
Access Point
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Eudamed.com (EirMed)
Eudamed.com (EirMed) provides a comprehensive search engine for EU and US medical device databases, facilitating M2M integration and UDI compliance.
Eudamed.com, also known as EirMed, offers a specialized search engine designed to navigate and extract information from both EU and US medical device databases. This platform is crucial for businesses seeking to understand regulatory landscapes and device compliance. It specifically supports Machine-to-Machine (M2M) integration, allowing for seamless data exchange and automated processes. Furthermore, Eudamed.com aids in managing Unique Device Identification (UDI) requirements, ensuring that manufacturers and distributors meet global standards. The service is geared towards streamlining access to critical device information for various stakeholders within the medical device industry.
Website:
eudamed.com
HQ:
US
Languages:
English
Modules:
UDI/Devices
Features:
Access Point
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osapiens for Medical Devices (BYRD Health)
osapiens provides a unified platform for sustainable growth, offering AI-driven solutions for supply chain transparency, risk mitigation, and efficiency. Specializing in regulatory compliance for industries like Medical Devices.
osapiens offers a comprehensive, AI-driven platform designed to empower companies in achieving sustainable growth. Their solutions focus on unlocking supply chain transparency, mitigating risks, and maximizing operational efficiency. By managing processes across the entire value chain, osapiens helps reduce manual work through automation, accelerate workflows, and minimize disruptions. With a strong emphasis on regulatory compliance, osapiens provides expertise in critical areas such as CSRD, CSDDD, and EUDR, offering practical guides and solutions tailored to today's most important regulations. They serve a diverse range of industries, including Medical Devices, by providing tools for Product Compliance & Transparency, Resilience & Risk Management, and Disclosures & Reporting. Their platform acts as a one-stop shop for transparency, efficiency, and compliance, enabling businesses to enhance performance and increase output. osapiens is committed to supporting clients in navigating complex regulatory landscapes and achieving their sustainability goals through innovative technology and expert guidance.
Website:
osapiens.com
Languages:
English, German, French
Modules:
UDI/Devices
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atrify (1WorldSync)
1WorldSync is a leader in product content orchestration, offering a global commerce network for efficient product data management, syndication, and content creation. They specialize in PIM software and managed services to enhance e-commerce sales growth.
1WorldSync provides a comprehensive suite of solutions for product content management and orchestration, serving as a leading global commerce network. Their offerings include Product Information Management (PIM) software, expert managed services for sourcing, creating, and validating product content, and world-class image capture assets. They enable businesses to aggregate, validate, and communicate product content, integrating seamlessly with ERP systems. 1WorldSync also facilitates the syndication of product content to trading partners and major retailer sites, helping to build high-impact content for product detail pages. Their platform is designed to maximize conversions and drive e-commerce sales growth. With a strong commitment to security, evidenced by SOC 2 attestation and ISO 27001 certification, 1WorldSync ensures the integrity and reliability of product data. They offer specialized solutions for content creation, including product photography and item setup automation, as well as user-generated content management. Their services are tailored to help businesses navigate the complexities of product content in today's digital marketplace.
Website:
atrify.com
HQ:
Chicago, United States
Languages:
German, English, French
Pricing model:
Custom pricing
Modules:
Actor
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Rimsys
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech teams. Automate regulatory processes, centralize data, and accelerate time-to-market with their cloud-based solution.
Rimsys provides a holistic RIM software solution designed to digitize and automate regulatory activities for MedTech companies. Their platform centralizes all regulatory information, including registrations, certificates, submission documents, and UDI data, creating a single source of truth. This helps regulatory affairs teams work more efficiently, reduce compliance risks, and bring products to market faster. The Rimsys platform is specifically built to address the complexities of global regulatory compliance, including EUDAMED. It offers purpose-built tools and expert guidance to streamline data collection, verification, and submission processes. By automating workflows and providing real-time alerts, Rimsys empowers companies to manage product registrations, selling status, and the impact of regulatory changes with confidence. With a focus on security and privacy, Rimsys ensures data is protected through encryption, role-based access controls, and regular audits. Their flexible, cloud-based pricing model scales with customer success, making advanced regulatory management accessible to teams of all sizes.
Website:
rimsys.io
HQ:
US
Languages:
English
Pricing model:
Custom pricing
Modules:
UDI/Devices, Certificates
Features:
Access Point
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DDi (Visu eIFU)
DDi (Visu eIFU) provides electronic Instructions for Use (eIFU) solutions for the eIFU platform. They specialize in delivering digital documentation to enhance user access and compliance.
DDi (Visu eIFU) is a specialized provider within the eIFU platform, focusing on the delivery of electronic Instructions for Use (eIFU). Their core offering revolves around making critical product information accessible digitally, streamlining processes for manufacturers and end-users alike. By leveraging the eIFU platform, DDi (Visu eIFU) ensures that users can easily access up-to-date and compliant documentation. This digital approach not only improves user experience by providing readily available information but also supports regulatory compliance and reduces the environmental impact associated with traditional paper-based manuals. Their expertise in eIFU solutions positions them as a key partner for companies seeking to modernize their product support and information dissemination strategies. DDi (Visu eIFU) is committed to facilitating efficient and effective communication of essential product guidance through advanced digital means.
Website:
ddismart.com
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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Asphalion
Asphalion is a scientific, safety, and regulatory affairs consultancy with offices in Barcelona, Madrid, Munich, and London. They offer comprehensive support for medical device regulations and training for the biotech, pharma, and medtech industries.
Asphalion is an international consultancy firm specializing in Scientific, Safety, and Regulatory Affairs, with a strong presence in Barcelona, Madrid, Munich, and London. Since its founding in 2000, Asphalion has become a reference in the international healthcare sector, offering expert consulting, strategic advice, operational support, and full outsourcing services for all product life cycle stages. They provide comprehensive support for worldwide Medical Device Regulations and training courses tailored for the Biotech, Pharma, and Medtech industries. Their mission is to collaborate with clients to generate ideas and implement solutions that improve health, aiming to be a global reference and a driving force in the evolution of the healthcare sector. With a track record of delivering solutions to over 1,000 companies from more than 50 countries across over 5,000 projects, Asphalion covers non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions, and data management for both medicinal products and medical devices. They also participate in Horizon EU programs and offer services categorized by stage of development, including Preclinical, Clinical development, Registration, and Life-Cycle Management. Asphalion is committed to sustainability, aligning with the UN’s 2030 Agenda and its Sustainable Development Goals.
Website:
asphalion.com
HQ:
Barcelona, ES
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English, Spanish, French, German
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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udihub.io
UDI Hub & UDI Connect offer automated UDI compliance solutions, simplifying data centralization, submission, and global regulatory database integration for EUDAMED.
UDI Hub & UDI Connect provide automated solutions to centralize UDI data, automate submissions, and ensure global compliance effortlessly. They cater to tech-driven teams needing API-first integration and those seeking an all-in-one solution for UDI management. These services streamline the entire UDI workflow, from data validation to submission, simplifying compliance with global regulatory databases like EUDAMED. Trusted by companies to enhance efficiency and ensure compliance.
Website:
udihub.io
Jurisdictions:
EU
Countries:
DE, FR, GB
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
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GlobalCompliance Solutions Pro
Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.
Website:
globalcompliance-solutions.com
HQ:
Boston, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Modules:
Actor, UDI/Devices, Vigilance
Features:
Access Point, Domibus, Sandbox
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MedReg International Pro
Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.
Website:
medreg-international.com
HQ:
London, UK
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Modules:
Actor, UDI/Devices, Vigilance
Features:
Access Point, Domibus, Sandbox
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Regulatory Excellence Partners Pro
Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.
Website:
regulatoryexcellence.com
HQ:
San Francisco, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Modules:
Actor, UDI/Devices, Vigilance
Features:
Access Point, Domibus, Sandbox
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Comprehensive Buyer's Guide
1. Who Needs EUDAMED M2M Integration?
Organizations placing medical devices on the EU market need to submit data to EUDAMED. For higher volumes (>1000 devices), M2M integration becomes more efficient than manual entry or bulk XML upload[1].
Deadline-driven requirement: The European Commission announced that as from 28 May 2026, the first four EUDAMED modules become mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance[2]. Organizations needing M2M integration should plan accordingly.
This requirement applies to:
- Manufacturers with large device portfolios (>1000 devices) needing automated submission
- Organizations requiring real-time synchronization with EUDAMED
- Companies wanting to automate their regulatory data pipeline
- Teams needing to submit data across multiple EUDAMED modules (Actor, UDI, Vigilance, Clinical Investigations)
Volume guidance: According to European Commission guidance[1]:
- ≤100 devices: Use manual UI entry (cheapest, no additional software)
- 100-1000 devices: Use bulk XML upload (more cost-effective than M2M)
- >1000 devices: Use M2M (most efficient, but requires Access Point)
References
- EC M2M user guide (European Commission) — 2025-12
- EUDAMED Mandatory Use Notice (European Commission) — 2025-12
2. How EUDAMED M2M Integration Works
EUDAMED M2M integration follows the official European Commission workflow[1]:
- Actor Registration & LAA Access: Complete your Economic Operator registration in EUDAMED and ensure you have Local Actor Administrator (LAA) access. LAA access is required to request and manage Access Points[1].
- Access Point Setup: Choose whether to self-host Domibus or use a 3rd-party Access Point provider. If using a provider, obtain their Party ID and technical details.
- Request New Access Point via Access Point Management: Log in to EUDAMED as Local Actor Administrator and navigate to "Access point management" to request a new Access Point[1]. Provide the Access Point Party ID and technical configuration details.
- 3rd Party Agreement: When using a 3rd-party Access Point provider, upload the signed 3rd-party agreement PDF during the Access Point request process.
- Technical Contacts: Submit technical and legal contact information as required by EUDAMED for the Access Point request.
- Playground Testing: Test your M2M connection in the EUDAMED Playground environment first. Verify message exchange, certificate handling, and data synchronization before requesting Production access.
- Security Keys Per Module: Critical: Generate a separate security key for each EUDAMED module you'll use (Actor, UDI/Devices, Vigilance, Clinical Investigations, Certificates, etc.)[2]. The security key is specific for each module — this is where many M2M projects fail if not properly configured.
Important Rules:
- 2 Access Points Maximum: Economic Operators can have up to two Access Points in certain statuses[1]. This is a common blocker if you're not aware of the limit.
- Security Key Per Module: Each EUDAMED module requires its own security key[2]. Ensure you generate and configure separate keys for each module you plan to use.
- Always Test in Playground First: Complete Playground testing before requesting Production access to avoid production issues.
References
- EC Access Point Management (European Commission) — 2025-12 — Access point management
- EC M2M user guide (European Commission) — 2025-12 — Security keys per module
3. What Services Are Typically Included?
EUDAMED M2M providers typically offer:
- Access Point Provision: Hosted Domibus Access Point or support for self-hosted Domibus
- M2M Integration: API integration with EUDAMED modules (Actor, UDI/Devices, Vigilance, Clinical Investigations, Certificates)
- PKI Certificate Management: Certificate generation, installation, rotation, and troubleshooting
- Sandbox/Playground Support: Testing environment before Production
- API Documentation: Endpoints, authentication methods, rate limits, error handling
- Monitoring & Logs: API monitoring, audit logs, error tracking
- Onboarding Support: Setup assistance, documentation, training
- Support Services: 24/7 or business hours support, incident handling
Additional services: Some providers also offer UDI data management, EUDAMED validation, XML bulk upload options, and broader regulatory compliance support.
4. What Affects Pricing?
EUDAMED M2M pricing varies based on:
- Access Point model: Self-hosted (you manage infrastructure) vs. hosted (provider manages)
- Pricing model: Per message, per tenant, flat subscription, or custom
- Volume: Number of devices, UDIs, or messages submitted
- Modules supported: Number of EUDAMED modules (Actor, UDI, Vigilance, etc.)
- Support level: Basic vs. 24/7 support, response SLAs
- Additional services: UDI data management, validation, onboarding assistance
Pricing examples: Some providers offer tiered pricing starting around €79/month for basic UDI management with optional M2M add-ons (€50/month for M2M Connection add-on). Enterprise solutions are typically quote-based.
5. Key Takeaways
- ≤100 devices: Use manual UI entry (cheapest option)
- 100-1000 devices: Use bulk XML upload (more cost-effective than M2M)
- >1000 devices: Use M2M (most efficient, requires Access Point)
6. How to Choose a Provider
Key questions to ask vendors:
- Uptime SLA: What is your uptime SLA and how is it monitored?
- Support: What support is included (24/7, business hours, response times)?
- PKI Certificates: Who handles PKI certificate generation, installation, and rotation?
- Sandbox: Do you provide a Playground/sandbox environment for testing?
- System Updates: How do you handle EUDAMED system updates and changes?
- Monitoring: What monitoring and alerting do you provide?
- Change Management: What is your change management process?
- Costs: What are the costs for additional UDIs or increased message volume?
- Onboarding: Do you offer onboarding assistance and documentation?
Frequently Asked Questions
Q1: Can I host Domibus myself?
Yes, you can self-host Domibus as your Access Point. This requires installing and configuring Domibus, managing PKI certificates, ensuring uptime, and handling security updates. Many teams choose a hosted Access Point provider to avoid the operational overhead of managing Domibus infrastructure, PKI certificate rotation, and 24/7 monitoring.
References
- EC M2M user guide (European Commission)
Q2: What's the cheapest path to EUDAMED compliance?
For small volumes (≤100 devices), manual UI entry is typically the cheapest option with no additional software costs. For 100-1000 devices, bulk XML upload may be more cost-effective than M2M. For >1000 devices, M2M becomes more efficient, but you'll need to factor in Access Point costs (self-hosted Domibus or a provider's service). Some providers offer tiered pricing starting around €79/month for basic UDI management with optional M2M add-ons.
References
- EC M2M user guide (European Commission)
Q3: When is M2M worth it vs XML bulk upload?
According to European Commission guidance: use UI for ≤100 devices, bulk XML upload for 100-1000 devices, and M2M for >1000 devices. M2M provides real-time synchronization and automation but requires an AS4/eDelivery Access Point. XML bulk upload is simpler but requires manual file preparation and upload cycles. M2M is worth it if you have high volume, need real-time updates, or want to automate your regulatory data pipeline.
References
- EC M2M user guide (European Commission)
Q4: What is an Access Point Party ID?
The Access Point Party ID is a unique identifier assigned to your Access Point in the EUDAMED system. When you request a new M2M access point in EUDAMED, you'll receive a Party ID that identifies your Access Point for message routing. If using a 3rd-party Access Point provider, they will provide you with their Party ID and technical details needed for the EUDAMED Access Point request.
References
- EC Access Point Management (European Commission)
Q5: Why do PKI certificates slow teams down?
PKI (Public Key Infrastructure) certificates are required for secure AS4/eDelivery message exchange with EUDAMED. Teams often face delays due to: certificate generation complexity, understanding certificate requirements, certificate installation and configuration, certificate expiration management, and troubleshooting certificate-related connection issues. Many Access Point providers handle PKI certificate management as part of their service, reducing this burden.
Q6: What is the 3rd-party agreement and who signs it?
When using a 3rd-party Access Point provider (not your own), EUDAMED requires you to upload a 3rd-party agreement PDF during the Access Point request process. This agreement typically outlines the relationship between you (the Economic Operator) and the Access Point provider, confirming they will act as your Access Point for EUDAMED M2M communication. The agreement is usually signed by both parties before submission to EUDAMED.
References
- EC Access Point Management (European Commission)
Q7: Do I need M2M for manual entry?
No, M2M is not required for manual UI entry in EUDAMED. Manual entry is done directly through the EUDAMED web interface. M2M is only needed if you want to automate data submission via machine-to-machine communication. If you're manually entering data through the UI, you don't need an Access Point or M2M setup.
Q8: How long does onboarding usually take?
Onboarding timelines vary: Playground environment setup typically takes 1-2 weeks (Access Point request, certificate setup, initial testing). Production onboarding can take 2-4 weeks after Playground approval, including security key generation, final testing, and go-live. Self-hosted Domibus setup may add 2-4 weeks for infrastructure setup. Using a hosted Access Point provider can reduce setup time to 1-2 weeks total.
Q9: Can one Access Point be reused for other eDelivery applications?
Yes, a single Access Point can be configured to support multiple eDelivery applications beyond EUDAMED. Domibus (the Access Point software used by EUDAMED) supports multiple message exchange protocols and can route messages to different endpoints. However, each application (like EUDAMED) will have its own Party ID and configuration requirements. Check with your Access Point provider about multi-application support.
Q10: What should I ask vendors before signing? (SLA, support, cert rotation, monitoring, sandbox, change mgmt)
Key questions: What is your uptime SLA and how is it monitored? What support is included (24/7, business hours, response times)? Who handles PKI certificate generation, installation, and rotation? Do you provide a Playground/sandbox environment for testing? How do you handle EUDAMED system updates and changes? What monitoring and alerting do you provide? What is your change management process? What are the costs for additional UDIs or increased message volume? Do you offer onboarding assistance and documentation?
Q11: What is AS4 and eDelivery?
AS4 (Applicability Statement 4) is a messaging protocol standard for secure, reliable business-to-business document exchange. eDelivery is the European Commission's framework for secure electronic document exchange between public administrations and businesses. EUDAMED uses AS4/eDelivery for M2M communication, which is why you need an AS4-compliant Access Point (like Domibus) to connect to EUDAMED via M2M.
Q12: What is Domibus?
Domibus is open-source software that implements the AS4 eDelivery Access Point specification. It's the Access Point software used by EUDAMED on its side for M2M communication. You can either self-host Domibus as your Access Point, or use a provider that hosts/manages Domibus for you. Domibus handles secure message exchange, PKI certificate management, and message routing according to AS4/eDelivery standards.
Provider Comparison Table
| Provider | Coverage | Key Features | Languages | Response SLA |
|---|---|---|---|---|
| EUDAMED Specialists | EU | Request quote | English | 24h |
| tracekey UDI Manager | EU | Request quote | English, German | 24h |
| Innovit | EU | Request quote | English | 24h |
| tracekey (mytracekey UDI Manager) | Request quote | German | Request quote | |
| Ademico Software | Request quote | English | Request quote | |
| Innovit | Request quote | English | Request quote | |
| ACKOMAS | Request quote | French, Italian | Request quote | |
| Eudamed.com (EirMed) | Request quote | English | Request quote | |
| osapiens for Medical Devices (BYRD Health) | Request quote | English, German | Request quote | |
| atrify (1WorldSync) | Request quote | German, English | Request quote |
Sources & Official Guidance
Official sources vary by directory. See the applicable regulation and competent authority guidance for this role.
Last Updated: 2026-02-03
Reviewed by: Cruxi Regulatory Affairs Team
