EUDAMED Onboarding & Data Registration Support (Actor/SRN, UDI/Devices)

EUDAMED onboarding is operational work: access governance, actor registration (SRN), and preparing structured UDI/device data that passes validations. Compare specialized providers and request quotes for onboarding, bulk submissions, and optional M2M integration.

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Compare EUDAMED Onboarding & Data Registration Support (Mandatory Modules) 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.

Euverify Pro

Euverify provides automated compliance tools and GDPR Representative services to help businesses meet EU/UKCA regulations. Streamline your compliance journey with expert guidance.

Euverify offers a comprehensive platform designed to simplify your compliance journey. Their services include automated compliance tools for EU/UKCA regulations, helping you generate necessary declarations and understand complex requirements. They also provide a GDPR Representative Module, assisting businesses in meeting their obligations under GDPR. The Euverify Help Center offers step-by-step guides, feature explanations, and answers to common compliance questions, ensuring you can efficiently manage your account, appoint authorized representatives, and keep your products legally compliant. Whether you are new to compliance or switching systems, Euverify aims to make the process seamless and efficient.
Website: euverify.com
HQ: London, GB
Languages: English
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Obelis Group

Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland.

Obelis Group offers comprehensive regulatory compliance services to facilitate swift and safe market entry for your products worldwide. Specializing in Medical Devices, Cosmetics, and other industries, they provide expert guidance as an Authorized Representative and Responsible Person. Their services span regulations in the EU, UK, US, Switzerland, and Canada, ensuring your products meet diverse international requirements. For the cosmetics industry, Obelis Group provides tailored solutions including Responsible Person services, PIF review, CPNP notifications, label reviews, and product safety reports for markets like the EU, UK, US, and Canada. They also offer US Agent services and FDA facility/FEI registration to navigate the complexities of the US market under MoCRA. With deep experience in EU, UK, and Swiss compliance frameworks, Obelis Group is well-equipped to support your product's journey to market. They act as your official contact with regulatory authorities, manage documentation, and ensure post-market obligations are met, protecting your brand and consumer trust.
Website: obelis.net
HQ: Brussels, Belgium
Languages: English, French, Dutch, German
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i3CGlobal (ISO 13485 SOP Templates)

i3CGlobal offers expert medical device regulatory consulting, specializing in MDR/IVDR compliance, CE marking, and technical documentation. They ensure efficient project delivery and data security.

i3CGlobal is a trusted regulatory consulting company and a sustainable partner for medical device manufacturers. They specialize in navigating the complexities of regulatory documentation and registrations with authorities, offering expert services for EU MDR/IVDR, FDA, drugs, food supplements, and cosmetics. With a dedicated team of full-time regulatory experts, i3CGlobal ensures prompt and efficient project commencement and on-time delivery. They are committed to fair and transparent pricing, attracting a global clientele. Their services include comprehensive support for CE Marking, technical file creation, clinical evaluations, risk management, and appointing European Authorized Representatives. Data security is paramount, with ISO 27001 certification ensuring the confidentiality and integrity of client information. i3CGlobal operates 24/7, delivering documents securely via the cloud, providing a reliable and secure regulatory consulting service. They are particularly adept at assisting startups with new medical software and ensuring compliance for importing and marketing devices in Europe.
Website: i3cglobal.com
HQ: Bengaluru, India
Languages: English
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CMC Medical Devices (EU AR)

CMC Medical Devices offers expert regulatory consulting and representation for medical device manufacturers seeking EU and global market access. They specialize in MDR, IVDR compliance, and acting as your EU Authorized Representative (EC REP).

CMC Medical Devices is a leading international consulting firm specializing in regulatory affairs for medical devices. Based in Spain, they provide personalized services to help manufacturers achieve regulatory compliance and market access in various countries, including representation services for the EU (EC REP) and UK (UK RP). They offer comprehensive support for navigating complex regulations such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Their expertise includes QMS implementation, EUDAMED registration, and obtaining Free Sale Certificates. CMC Medical Devices acts as a crucial point of contact with local authorities, ensuring smooth communication and continuous compliance for clients outside the EU and UK. With a professional technical team and established offices in key regions like the UK, Switzerland, China, Australia, and the USA, CMC Medical Devices is committed to becoming a reliable partner for medical device manufacturers worldwide. They focus on accelerating product approvals and facilitating business expansion through strategic representation and consultancy services.
HQ: Spain, ES
Languages: English, French, Dutch
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MedEnvoy

MedEnvoy simplifies medical device, IVD, and cosmetic market entry into EU, UK, and Switzerland with expert regulatory representation and importer ser

MedEnvoy simplifies bringing medical devices, IVDs, and cosmetics to market by overcoming complex regulations. They offer expert In-Country Representation and Regulatory Importer services for the EU, UK, and Switzerland, acting as a single, independent point of contact
HQ: Seattle, United States
Languages: English
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MedQAIR

MedQAIR is a global partner for medical device and AI Act compliance, offering expert consulting for market entry, regulatory affairs, and quality management systems. They specialize in navigating complex regulatory frameworks for AI-enabled devices and SaMD.

MedQAIR is a leading medical device consulting company specializing in regulatory compliance and quality management for both medical devices and Artificial Intelligence (AI) solutions. They offer comprehensive services including Authorised Representative and PRRC support, assisting manufacturers in navigating complex regulatory landscapes for EU & US market access, as well as other global jurisdictions. Their expertise extends to AI-enabled devices, including those utilizing machine learning, deep learning, and large language models. MedQAIR helps streamline regulatory strategy, clinical planning, and technical documentation preparation for submissions. They are also experienced in Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD), guiding clients through evolving digital health regulations. With an ISO/IEC 27001:2022 certification, MedQAIR ensures robust information security across their services. They support the implementation of regulatory systems like Quality Systems (ISO 13485) and Information Security Management Systems (ISO/IEC 27001). Their mission is to simplify market entry for safe, compliant, and innovative healthcare products, acting as a trusted partner for economic operators throughout the product lifecycle.
Website: medqair.com
HQ: Amsterdam, NL
Languages: English
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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
Languages: English
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EUDAMED Medical Consulting

EUDAMED Medical Consulting offers expert guidance on navigating the EUDAMED database for medical devices and in-vitro diagnostic devices. They specialize in Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates Module.

EUDAMED Medical Consulting is a specialized provider assisting companies with the complexities of the European Databank On Medical Devices (EUDAMED). They offer comprehensive support for crucial EUDAMED modules, including Actor Registration, UDI/Device Registration, and the Notified Bodies and Certificates Module. Their expertise ensures compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). They help clients manage EUDAMED processes, ensuring accurate registration of devices, economic operators, and relevant documentation. Whether you are a manufacturer, importer, or authorized representative, EUDAMED Medical Consulting provides the necessary guidance to successfully integrate with the EUDAMED system, enhancing transparency and coordination within the EU market.
HQ: Brussels, EU
Languages: English, French
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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
Languages: English, German
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Reed Tech

Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services for global health authorities.

LexisNexis Reed Tech is a leading provider of information-based solutions and services for the Life Sciences industry. They specialize in managing medical device Unique Device Identification (UDI) product data for global health authorities, offering expertise in UDI data submission and product lifecycle management. Their services include outsourced Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Reed Tech serves a wide range of clients, from small to mid-size producers and distributors to the largest global leaders in the pharmaceutical and medical device sectors. With a focus on regulatory compliance and data accuracy, Reed Tech's SingleSource™ platform for Medical Devices ensures UDI data is managed in a compliant SaaS environment, with scalability for increased volume and global health authorities. They actively support UDI channels for US FDA, China NMPA, South Korea MFDS, and are staging for EU EUDAMED and Australia UDID, demonstrating their commitment to global regulatory support.
Website: go.reedtech.com
HQ: Horsham, US
Languages: English
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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
Languages: English
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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.
Languages: English
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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
Languages: English
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MedEnvoy Global

End-to-end medical device registration management with proprietary GloRIAS platform for efficient EUDAMED data management and submissions.

HQ: Den Haag, NL
Jurisdictions: EU
Countries: Netherlands, Germany, France, UK
Languages: English, Dutch, German, French
Pricing model: Retainer
Modules: Actor/SRN, UDI/Devices
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 6+ weeks
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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: Spain, France, Germany, Italy
Languages: English, Spanish, French, German
Pricing model: Per project
Modules: Actor/SRN
Submission Approach: Portal
Portfolio Fit: 100+
Onboarding Speed: 6+ weeks
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ELLECOM

Fletcher Landgoed Hotel Avegoor is a characteristic hotel in Ellecom, uniquely situated in the Veluwe region near Arnhem. It offers a pleasant stay with various facilities, including a sauna, indoor pool, and versatile meeting rooms, perfect for both leisure and business.

Fletcher Landgoed Hotel Avegoor is a distinctive hotel nestled in Ellecom, uniquely positioned in the heart of the Veluwe and close to the vibrant city of Arnhem. This historic estate provides an ideal setting for a memorable stay, whether you're seeking a weekend of nature and culture or a special event. The hotel boasts a range of amenities designed for relaxation and enjoyment. Guests can unwind in the sauna or take a dip in the indoor swimming pool. For those planning business meetings or celebrations, the hotel offers well-equipped, multifunctional conference rooms. The culinary experience at Fletcher Landgoed Hotel Avegoor is centered around its atmospheric restaurant. Here, guests can savor delicious dishes prepared by the chef and his team, with a focus on honest food and regional products. The surrounding area offers numerous excursion opportunities, including the beautiful nature reserves of the IJssel Valley and the Veluwe, as well as the nearby city of Arnhem for day trips.
Website: ellecom.de
HQ: Ellecom, Netherlands
Jurisdictions: EU
Countries: Germany, France, UK
Languages: English, German, French
Pricing model: Per project
Modules: Actor/SRN, UDI/Devices, Certificates
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 1-5
Onboarding Speed: 1-2 weeks
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MDSS

MDSS is a leading Authorized Representative and regulatory affairs specialist for medical and IVD devices. They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia, including EUDAMED registration support.

MDSS has over 30 years of experience as a trusted Authorized Representative and regulatory affairs consultant for Medical and In Vitro Diagnostic Devices. They provide essential in-country representation services across the EU, United Kingdom, Switzerland, USA, and Australia, acting as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent, and Australian TGA Sponsor. Specializing in EUDAMED registration, MDSS offers a full-service solution from initial setup to ongoing maintenance, ensuring continued market access for devices. They assist non-EU based companies in complying with regulations such as the AI Act and GPSR by appointing MDSS as their EU Representative. With a commitment to regulatory compliance and market access, MDSS serves as the pivotal contact for European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA. Their expertise empowers companies to navigate complex regulatory landscapes and achieve success in the European arena and beyond.
Website: mdss.com
HQ: Hannover, Germany
Jurisdictions: EU
Countries: Germany, France, Spain, Italy, Netherlands
Languages: English, German, French, Spanish
Pricing model: Custom pricing
Modules: Actor/SRN, UDI/Devices
Submission Approach: Portal
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Eudamed.com

Eudamed.com offers specialized online training for EUDAMED, covering actor registration, device data, and data submission requirements. Learn from experts who developed the system.

Eudamed.com provides comprehensive online self-paced training designed to guide users through the complexities of the EUDAMED system. Leveraging the expertise of individuals who were part of the European Commission teams that created EUDAMED, this training covers essential aspects such as actor registration for your SRN and device data management. The curriculum is structured to teach you how to prepare your data for uploads, navigate the web-based EUDAMED input forms, and understand the specific data requirements. Key modules include an introduction to EUDAMED, understanding XSDs and data submissions, data exchange, machine-to-machine access, message encapsulation, actor registration and user management, UDI device registration, and EC publications. This training is essential for anyone embarking on a EUDAMED project, ensuring you have all the necessary knowledge to get started effectively.
HQ: Brussels, EU
Jurisdictions: EU
Countries: Belgium, France, Germany, Spain
Languages: English, French, German, Spanish
Pricing model: Custom pricing
Modules: Actor/SRN, UDI/Devices
Submission Approach: Portal, Bulk Submissions
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EUDAMED Experts Consulting

The FDA Group provides specialized RA/QA subject matter experts for life science organizations, offering a proprietary matching process for consultants and contractors to ensure precise needs are met for critical projects.

The FDA Group is a life science consulting, staffing, and recruitment firm that connects organizations with specialized RA/QA subject matter experts. They utilize a proprietary matching process to provide contracted or embedded SMEs who combine strategic insight with hands-on execution, ensuring they fit exact needs for high-level strategy or hands-on execution. These experts integrate quickly, work independently, and are supported by The FDA Group's internal project management and a full performance guarantee. Headquartered in Boston, Massachusetts, The FDA Group has a global reach with over 3,750 resources worldwide, including over 325 former FDA employees, located in 48 states and 75 countries. They focus on enhancing the quality of people's lives by helping clients move critical projects forward with speed, precision, and confidence, supporting every stage of the product lifecycle from clinical development through commercialization.
HQ: Boston, US
Jurisdictions: EU, US
Countries: NL
Languages: English, Dutch, German, French
Response SLA: 24 hours
Onboarding time: 7–14 days
Pricing model: Custom pricing
Modules: UDI/Devices
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 2-6 weeks
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Regulatory Data EUDAMED

Celegence provides AI-powered regulatory services and technology solutions for Pharmaceutical, Medical Device, and IVD manufacturers, specializing in EUDAMED compliance and global regulatory affairs.

Celegence is a leading regulatory affairs service provider offering AI-empowered solutions for Pharmaceutical, Medical Device, and In-Vitro Diagnostics (IVD) customers. They specialize in navigating complex global regulations, including EUDAMED mandatory compliance for medical device and IVD manufacturers, with a particular focus on the May 28, 2026 deadline. Their services encompass the entire product lifecycle, from regulatory strategy and authoring to submission management, publishing, and health authority interaction. Celegence leverages a global team of consultants to provide local regulatory insight, strategy, and intelligence, ensuring clients achieve efficient, consistent, and compliant operations. They offer expertise in areas such as CER maintenance, CMC Module 3 documentation enhancement with GenAI, and UDI registration. Celegence is committed to delivering measurable impact in regulatory compliance, backed by certifications like ISO 9001:2015, ISO 27001:2022, and a high CSAT score. Their technology solutions include Dossplorer™ Cloud eCTD Viewer & Manager, Dosscriber™ eCTD Document Templates, and CAPTIS® AI and Automation Technology, designed to streamline regulatory processes and enhance data governance.
HQ: Downers Grove, USA
Jurisdictions: EU, US
Countries: LU
Languages: English, French, German
Response SLA: 24 hours
Onboarding time: 7–14 days
Pricing model: Custom pricing
Modules: UDI/Devices
Submission Approach: Portal
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Med Device Registration EU

The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

The European Medicines Agency (EMA) plays a crucial role in the EU's regulatory framework for medicines. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines. The EMA's work includes recommending medicines for authorization, managing risks associated with medicine use, and providing access to the latest information and regulatory guidance. They also focus on advancing safe and ethical AI practices across the medicines lifecycle and contribute to new pharmaceutical legislation. The agency also covers veterinary medicinal products and medical devices, offering a comprehensive approach to health and safety within the EU. Key activities include evaluating new active substances, providing updates on medicines under evaluation, and maintaining national registers. The EMA's remit extends to research and development, marketing authorization, and post-authorisation surveillance, ensuring the highest standards for medicinal products available to EU citizens.
HQ: Berlin, NL
Jurisdictions: EU, US
Countries: DE
Languages: English, German, French
Response SLA: 24 hours
Onboarding time: 7–14 days
Pricing model: Custom pricing
Modules: UDI/Devices
Submission Approach: Portal
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EUDAMED Onboarding Services

Innovit provides GDSN and UDI compliance solutions, specializing in EUDAMED and AusUDID data management for medical device manufacturers. Streamline regulatory compliance and data exchange.

Innovit offers specialized solutions for EUDAMED and AusUDID compliance, crucial for medical device manufacturers navigating complex global regulatory landscapes. Their GDSN Connector and EUDAMED.cloud system simplify the management, validation, and exchange of trusted product data, ensuring adherence to mandatory deadlines and requirements. With a focus on improving data quality and enabling regulatory compliance, Innovit's platforms help organizations manage UDI data, validate BUDI information, and prepare for submissions to regulatory bodies like the EU Commission and Australia's TGA. They provide tools for training, testing, and seamless data export, supporting both large-scale submissions and individual device registrations. Innovit's expertise extends to multi-domain Master Data Management (MDM) and workflow automation, assisting healthcare providers, medical device suppliers, and GPOs & Distributors in achieving and maintaining compliance. Their solutions are designed to reduce procurement spend, enhance supply chain analytics, and ultimately improve patient safety by ensuring accurate and accessible product data.
HQ: Austin, US
Jurisdictions: EU, US
Countries: GB
Languages: English, French, German
Response SLA: 24 hours
Onboarding time: 7–14 days
Pricing model: Custom pricing
Modules: UDI/Devices
Submission Approach: Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 2-6 weeks
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EUDAMED Compliance Partners

osapiens provides an AI-driven platform for supply chain transparency, risk mitigation, and efficiency, enabling sustainable growth and regulatory compliance.

osapiens offers a unified platform designed to empower companies in achieving sustainable growth through enhanced transparency and efficiency. Their AI-driven solutions help unlock supply chain insights, mitigate risks, and automate processes, reducing manual work and accelerating workflows. By providing a one-stop shop for critical regulations like CSRD, CSDDD, and EUDR, osapiens assists organizations in navigating complex compliance landscapes and making data-backed decisions. With a global presence and a diverse team, they are committed to delivering innovative technology that fosters responsible business practices and long-term success for their clients.
HQ: Mannheim, Germany
Jurisdictions: EU, US
Countries: IT
Languages: English, Italian, French, Spanish, German
Response SLA: 24 hours
Onboarding time: 7–14 days
Pricing model: Custom pricing
Modules: UDI/Devices
Submission Approach: Portal, M2M Integration
Portfolio Fit: 1-5
Onboarding Speed: 1-2 weeks
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Sobel Consult

EU Responsible Person (RP) for cosmetics. Expert support for CPNP notifications, PIF management, label reviews, and post-market vigilance. Full Article 4 mandate and compliance coordination.

Sobel Consult serves as your fully mandated EU Responsible Person (RP) for cosmetics, handling pre-market, on-market, and post-market obligations. They provide comprehensive RP services including Article 4 mandate formalization, CPNP notifications, Product Information File (PIF) access and retention management, label and claims verification, post-market vigilance coordination, and change control across your portfolio. Their RP workflow brings order and clarity to every regulatory obligation, helping products move into and remain on the EU market without gaps or delays. They operate as the legal gatekeeper of EU cosmetic compliance, ensuring each product remains compliant throughout its lifecycle.
Website: sobelconsult.com
HQ: Lisbon, PT
Languages: English, French, German
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ASC Services

ASC Services offers comprehensive regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals in the EU market.

ASC Services provides integrated advice and management for medical device licensing, design, certification, and market entry, ensuring compliance with EU Regulations 2017/745 and 2017/746, along with quality standards implementation. They offer full support for manufacturers and importers of cosmetics, including CPNP and CPSR processing, and have extensive experience in managing sanitary registrations for food products (RGSEAA), adapting labeling, and market communication within the EU. Their expertise extends to managing technical information for medicines, active ingredients, and manufacturing/import/distribution facilities. ASC Services also conducts quality control, biocompatibility, and toxicological testing for medical devices, cosmetics, medicines, and food products. They leverage experienced partners for comprehensive management of transport, import, customs clearance, and logistics for these product categories. Additionally, ASC Services offers a validated ERP system for integrated quality management of medical devices, cosmetics, and medicines, alongside custom IT solution development. They provide tailored training for companies in the health sector and specialized courses on medical devices and cosmetics.
Website: ascservices.es
HQ: Sevilla, ES
Languages: Spanish
Modules: Actor/SRN, UDI/Devices
Submission Approach: Portal, M2M Integration
Portfolio Fit: 1-5
Onboarding Speed: 2-6 weeks
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Advena Ltd

Advena Ltd is a specialized consultancy firm with over 25 years of experience in providing EU Authorised Representative (EU REP) services, regulatory affairs, and quality management support for medical device manufacturers. Established in 1996 and now based in Malta, Advena Ltd helps clients navigate the complexities of EU Medical Device and In Vitro Medical Device Regulations, facilitating access to the EU market. Their services include acting as an EU Authorised Representative, offering consultancy on technical documentation and quality management systems, and providing importer services. Advena Ltd is certified to ISO13485:2016 by IMQ and is a founding member of the European Association of Authorised Representatives (EAAR). They focus on supporting start-ups and small to medium-sized manufacturers, ensuring a strong client experience and regulatory compliance. Advena Ltd also assists with EUDAMED Actor Registration, helping manufacturers obtain their Single Registration Number (SRN) to ensure smooth operations within the EU regulatory framework. Their team of experienced professionals is dedicated to carrying the burden of responsibility with cost-effective regulatory solutions.
Website: advenaltd.eu
HQ: Swatar, MT
Languages: English
Modules: Actor/SRN
Submission Approach: Portal
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MDSS Consulting GmbH

MDSS Consulting GmbH offers expert regulatory consulting for medical devices and IVDs, specializing in EUDAMED onboarding and compliance. They provide comprehensive support for registration and ongoing management.

MDSS Consulting GmbH is a specialized consultancy focused on regulatory affairs for medical devices and In Vitro Diagnostic (IVD) products. They offer extensive expertise in navigating complex regulatory landscapes, with a particular emphasis on EUDAMED compliance and onboarding. Their services include guidance on EUDAMED registration for various roles, product registration, and managing updates within the database. They assist clients in understanding the requirements for SRN numbers, actor registration, and timely reporting of product information. MDSS Consulting GmbH provides tailored support, from initial consultations to full outsourcing of EUDAMED-related tasks. They aim to simplify the often daunting process of regulatory compliance, ensuring clients can bring their products to market efficiently and safely. Their team is dedicated to providing clear, actionable advice and practical solutions for manufacturers and authorized representatives.
Website: mdssco.com
HQ: Hannover, Germany
Languages: English, German
Modules: Actor/SRN
Submission Approach: Portal
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mdr-expert.com

Website: mdr-expert.com
Modules: Actor/SRN, UDI/Devices, Certificates
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 26-100
Onboarding Speed: 6+ weeks
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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
Languages: English
Modules: UDI/Devices
Submission Approach: M2M Integration, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 1-2 weeks
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p36.io

p36.io offers innovative cloud software solutions, specializing in the UDI Platform for Life Sciences companies. They streamline product data management and regulatory compliance for global market access.

p36.io is your partner for innovative cloud software solutions, dedicated to accelerating digital transformation within the Life Sciences industry. They help companies optimize processes, reduce costs, and simplify collaboration by leveraging modern cloud technologies. Their flagship product, the UDI Platform, is a cloud-based solution designed to manage medical device data centrally and facilitate direct exchange with regulatory authorities. This platform ensures flexibility, simplicity, and compliance with global UDI regulations. It is individually tailored to meet specific business needs and internal processes, enabling easy data preparation, rapid validation, and straightforward submission to authorities. p36.io also focuses on keeping clients informed about evolving market requirements and UDI regulations, ensuring data remains up-to-date. The UDI Platform integrates seamlessly with existing IT landscapes and regulatory systems, allowing for the transfer of existing data and direct data exchange. Beyond the UDI Platform, p36.io offers expertise in Cloud Consulting and Cloud Service Qualification, helping businesses navigate GxP-compliant cloud environments and manage the complexities of cloud transformation.
Website: p36.io
HQ: Germany
Languages: German, English
Modules: UDI/Devices
Submission Approach: M2M Integration
Portfolio Fit: 1-5
Onboarding Speed: 2-6 weeks
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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

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/SRN, UDI/Devices, Certificates
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 2-6 weeks
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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.

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/SRN, UDI/Devices, Certificates
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 2-6 weeks
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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

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/SRN, UDI/Devices, Certificates
Submission Approach: Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 2-6 weeks
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Comprehensive Buyer's Guide

1. Who Needs EUDAMED Onboarding & Data Registration Support?

EUDAMED (European Database on Medical Devices) is structured around 6 interconnected modules and a public website, including Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance, plus additional modules under development and release planning.[1]

You're most likely to need onboarding and data registration support if you are:

  • A manufacturer placing devices on the EU market and needing to register and maintain structured UDI/device information in EUDAMED workflows.[5]
  • An authorized representative supporting registrations and lifecycle updates for non-EU manufacturers (often as part of broader operational support).
  • A notified body or a manufacturer interacting with certificate-related workflows where applicable.[1]
  • A company with many SKUs where manual portal work becomes slow, inconsistent, and hard to evidence for audit.

Deadline-driven onboarding: The Commission states that publication of a notice triggered a 6-month transition period, and that as from 28 May 2026 the first four modules are mandatory to use (Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance).[1] A dedicated news announcement repeats this mandatory-use date.[2]

When outsourcing makes the most sense:

  • You need Actor/SRN setup configured correctly (roles, delegates, access governance) to avoid downstream submission failures.
  • Your UDI/device data is spread across ERP/PLM/labeling systems and needs mapping and transformation into the required structure.
  • You are encountering repeated validation errors that require a controlled, documented triage and fix cycle.
  • You want scale via machine-to-machine (M2M) submissions rather than manual uploads.[6]

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27
  2. The EUDAMED four first modules will be mandatory to use as from 28 May 2026 (European Commission — Public Health) — 2025-11-27
  3. Regulation (EU) 2017/745 (MDR) — Article 34 (European Union (EUR-Lex)) — 2017-04-05
  4. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

2. What Services Are Typically Included?

EUDAMED onboarding providers typically deliver a mix of access onboarding, data preparation, and submission operations. Common scopes include:

  • Access + role setup: assisting with user access, role definitions, delegation, and governance (who can submit what, and how changes are approved and controlled).
  • Actor registration / SRN support: operational support for registering economic operators and setting up the organization's profile for ongoing maintenance.[1]
  • UDI/Device dataset build: mapping your catalog into EUDAMED-required fields, including identifiers, packaging levels, and relationships across records.
  • Data quality + validation triage: resolving validation errors, missing mandatory fields, and inconsistencies (e.g., Basic UDI-DI vs UDI-DI misalignment).
  • Bulk submission operations: preparing import-ready datasets, running controlled batch submissions, and producing logs/evidence.
  • M2M integration (optional): setting up the pathway for M2M submissions (typically using an eDelivery/AS4 approach), testing, and monitoring, plus operational runbooks.[6]
  • Lifecycle maintenance: ongoing updates for new SKUs, identifier changes, and periodic data hygiene.

Often excluded (confirm in quotes): broader regulatory strategy, clinical evaluation/performance evaluation drafting, notified body negotiations, and QMS remediation—unless explicitly bundled.

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27
  2. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

3. What Affects Pricing?

EUDAMED onboarding pricing is typically driven by data volume, data cleanliness, module scope, and whether you need a technical integration.

  • Portfolio size: number of device families, SKUs, packaging levels, and update frequency.
  • Data maturity: consistency of identifiers (e.g., Basic UDI-DI / UDI-DI), completeness of required attributes, and availability of a controlled "source of truth."
  • Module scope: Actor/SRN only vs adding UDI/Device registration and certificate-related workflows.[1]
  • Submission approach: portal operations vs bulk submissions vs M2M integration (integration increases upfront cost but can reduce ongoing effort at scale).[6]
  • Support model: one-time onboarding vs managed service (retainer) for continuous portfolio changes.
  • Timeline urgency: expedited onboarding or "clean-room rebuild" of product data for near-term submissions.

Common pricing models: fixed-fee onboarding + per-SKU bands, portfolio onboarding project fee, monthly managed-service retainer, and M2M integration project + maintenance.

What a good quote includes: record-count estimates, explicit assumptions about data readiness, included validation/rework cycles, and concrete deliverables (datasets, mappings, SOPs, training, and audit evidence).

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27
  2. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

4. How to Choose a Provider

Choose an EUDAMED onboarding partner the same way you'd choose a data migration partner: validate their capability with your data shape and confirm they can operate under change control.

  • Module coverage: can they support Actor/SRN and UDI/Device registration end-to-end—and do they understand certificate-related workflows if you need them?
  • Data mapping capability: can they map from your ERP/PLM/labeling tools and show field-level mapping and example validation resolutions?
  • Validation playbook: ask how they triage failed validations, how they document fixes, and how many rework cycles are included.
  • Operational controls: do they provide SOPs, approvals, and traceability for submissions and updates?
  • M2M credibility (if needed): can they explain onboarding/testing, monitoring, incident handling, and the architecture expectations described by the Commission?[6]
  • Security + access: how do they manage credentials, least privilege, and data segregation across clients?

Red flags: vague "we handle everything" answers, no validation workflow, no mapping artifacts, or quotes that omit record counts and assumptions.

References

  1. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

5. Timeline & Process (Buyer Expectations)

  1. Discovery (1–2 weeks): modules, roles, record counts, and source systems.
  2. Data mapping (1–3 weeks): source-to-target mapping and transformation rules.
  3. Build + validate (2–6 weeks): dataset preparation, submissions/testing, error resolution, and documentation.
  4. Submit + handover: controlled submissions and training for maintenance.
  5. Ongoing maintenance (optional): managed updates and periodic data hygiene.

6. Buyer Preparation Checklist

  • Product catalog export (device families, SKUs) and packaging hierarchy.
  • Identifier inventory (Basic UDI-DI / UDI-DI, internal product codes, label IDs).
  • Labeling/IFU sources of truth and change-control process.
  • Legal entities + roles (manufacturer, authorized representative, importer), and which markets they apply to.
  • Target EU/EEA countries and language variants (if relevant for operations).
  • Preferred approach: portal/bulk vs M2M roadmap and target timeline.

Frequently Asked Questions

Q1: When do EUDAMED modules become mandatory?

The Commission states that a published notice triggered a 6-month transition period, and that as from 28 May 2026 the first four EUDAMED modules are mandatory to use (Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance).[1]

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27

Q2: Which EUDAMED modules should we plan for first?

Most companies start with Actor registration (roles and access governance) and UDI/Device registration (structured product/UDI data), then expand into additional workflows as needed. EUDAMED's module structure and state of play are described on the Commission's overview page.[1]

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27

Q3: Do I need M2M integration, or is the portal enough?

The portal can work for smaller or stable catalogs. M2M becomes valuable when you have large or frequently changing data, want repeatable submissions with evidence, or need to integrate outputs into internal systems. The Commission describes the M2M approach and architecture for submissions at scale.[6]

References

  1. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

Q4: What is SRN and why does it matter?

SRN (Single Registration Number) is associated with actor registration and helps uniquely identify economic operators in EUDAMED workflows. Onboarding support often focuses on configuring roles/delegates correctly so submissions and maintenance can be performed without access issues.[1]

References

  1. Overview — Medical Devices (EUDAMED) (European Commission — Public Health) — 2025-11-27

Q5: What causes most onboarding delays?

  • Inconsistent product master data across ERP/PLM/labeling systems
  • Unclear ownership of key identifier fields (Basic UDI-DI / UDI-DI)
  • Iterative validation errors that require controlled fixes and documentation
  • Access/role configuration issues and internal approval bottlenecks
  • M2M dependencies (access point onboarding, testing, and monitoring) when applicable[6]

References

  1. EUDAMED machine to machine (M2M) architecture (European Commission — Public Health) — 2025-12-16

Q6: Can we delegate submissions to a third party?

Many organizations use consultants or service providers for operational support, especially during initial onboarding or large portfolio migrations. If you delegate, clarify (1) who submits which records, (2) how changes are approved, (3) how credentials/roles are managed, and (4) what evidence you will keep for audit.

Q7: What should we include in an RFQ to get comparable quotes?

Include the modules you need, your estimated portfolio size (device families/SKUs/packaging levels), your data sources (ERP/PLM/labeling/spreadsheets), whether you want portal/bulk vs M2M, and target timelines. Ask providers to return record-count estimates, assumptions, included rework cycles, and handover deliverables.

Q8: Does EUDAMED apply to IVDs too?

IVDs fall under the IVDR, which includes provisions for the European database on medical devices (EUDAMED). Ensure your provider can support the IVDR context and your portfolio's specific data and lifecycle needs.[7]

References

  1. Regulation (EU) 2017/746 (IVDR) — Article 30 (European Union (EUR-Lex)) — 2017-04-05

Related Regulatory Services

EU Authorized Representative (EU AR) UK Responsible Person (UK RP) Swiss Authorized Representative (CH-REP) Person Responsible for Regulatory Compliance (PRRC) EU+UK Cosmetics Compliance DSA Article 13 Representative

Provider Comparison Table

Provider Modules Languages Response SLA
Euverify Pro Request quote English Request quote
Obelis Group Request quote English, French Request quote
i3CGlobal (ISO 13485 SOP Templates) Request quote English Request quote
CMC Medical Devices (EU AR) Request quote English, French Request quote
MedEnvoy Request quote English Request quote
MedQAIR Request quote English Request quote
EUDAMED Specialists Request quote English Request quote
EUDAMED Medical Consulting Request quote English, French Request quote
tracekey UDI Manager Request quote English, German Request quote
Reed Tech Request quote 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
Cruxi - Regulatory Compliance Services