--- title: "EUDAMED, Definition | MedTech Terms" description: "European Database on Medical Devices. Plain-English Regulatory definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eudamed#term", "name": "EUDAMED", "description": "EUDAMED is the IT system established by EU MDR/IVDR for registering devices, economic operators, certificates, clinical investigations, vigilance, and market surveillance information.", "url": "https://medtechterms.com/terms/eudamed", "termCode": "eudamed", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/eudamed#article", "headline": "EUDAMED", "description": "European Database on Medical Devices.", "url": "https://medtechterms.com/terms/eudamed", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/eudamed" }, "about": { "@id": "https://medtechterms.com/terms/eudamed#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "EUDAMED, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed/", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/udi#term", "name": "Unique Device Identification", "alternateName": "UDI", "url": "https://medtechterms.com/terms/udi" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "EUDAMED", "item": "https://medtechterms.com/terms/eudamed" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/eudamed#faq", "mainEntity": [ { "@type": "Question", "name": "When is EUDAMED mandatory?", "acceptedAnswer": { "@type": "Answer", "text": "The mandatory use of EUDAMED modules is staggered. Each module becomes mandatory once it is declared fully functional by the European Commission, and transitional periods may apply, as per the EU MDR implementation timeline." } }, { "@type": "Question", "name": "What information needs to be submitted to EUDAMED?", "acceptedAnswer": { "@type": "Answer", "text": "EUDAMED requires the submission of data related to devices, economic operators (manufacturers, authorized representatives, importers), certificates issued by Notified Bodies, clinical investigations, vigilance reports (serious incidents and field safety corrective actions), and market surveillance data." } }, { "@type": "Question", "name": "Who is responsible for submitting data to EUDAMED?", "acceptedAnswer": { "@type": "Answer", "text": "Manufacturers are primarily responsible for submitting device and economic operator data. Authorized representatives, importers, and Notified Bodies also have specific reporting obligations within EUDAMED, as defined by the EU MDR and IVDR." } }, { "@type": "Question", "name": "How does EUDAMED impact MedTech cybersecurity?", "acceptedAnswer": { "@type": "Answer", "text": "EUDAMED itself is an IT system, therefore, cybersecurity of the information within it is critical. While not directly related to the cybersecurity of individual medical devices, the integrity and confidentiality of the data submitted to EUDAMED are paramount to maintaining trust and accuracy in the MedTech ecosystem." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. EUDAMED [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # EUDAMED European Database on Medical Devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition EUDAMED is the IT system established by EU [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) for registering devices, economic operators, certificates, clinical investigations, vigilance, and market surveillance information. What the regulation says The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting) 2017/745) and In Vitro Diagnostic Regulation ( [IVDR](/terms/ivdr) 2017/746) mandate EUDAMED as a central database for various types of medical device and [IVD](/terms/ivd) data. Its purpose, as outlined in EU MDR Article 33, is to enhance transparency and coordination of information between Member States and the European Commission. The system facilitates device registration, economic operator registration, vigilance reporting, clinical investigation data management, and market surveillance activities across the EU. ## What this means in practice EUDAMED is being rolled out by module. Mandatory use of certain modules begins as each is declared functional. ## Examples - A manufacturer registers a new Class IIb medical device in EUDAMED, providing its UDI-DI, basic UDI-DI, and other relevant device characteristics, fulfilling requirements in EU MDR Annex VI, Part A. - An Authorized Representative updates its contact information within the EUDAMED economic operator module to ensure compliance with EU MDR Article 11, paragraph 2. - Following a serious incident involving a device in the EU, the manufacturer submits a vigilance report to EUDAMED, as required by EU MDR Article 87. Common pitfalls - • A common misconception is that EUDAMED is a single, fully functional system, when in reality it is being deployed in a modular fashion, with different functionalities becoming mandatory at different times. - • Companies often underestimate the data entry burden and the need for accurate, consistent data across all modules, leading to delays in compliance. - • Some stakeholders mistakenly believe that EUDAMED replaces national registration requirements entirely, which is not always the case, necessitating careful review of Member State specific guidance. - • Failing to establish a robust internal process for EUDAMED data submission and maintenance can result in non-compliance and potential market access issues in the EU. - • Assuming that EUDAMED functionality will be static can lead to issues, as the system is subject to ongoing updates and changes, requiring continuous monitoring by economic operators. ## Frequently asked questions When is EUDAMED mandatory? The mandatory use of EUDAMED modules is staggered. Each module becomes mandatory once it is declared fully functional by the European Commission, and transitional periods may apply, as per the EU [MDR](/terms/mdr-reporting) implementation timeline. What information needs to be submitted to EUDAMED? Who is responsible for submitting data to EUDAMED? How does EUDAMED impact MedTech cybersecurity? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Unique Device Identification(UDI) ](/terms/udi) ### Used by Things that build on this term. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### EU MDR Essentials · From this learning path [ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. Adjacent lesson ](/terms/notified-body?from=eu-mdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=eu-mdr-essentials)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=eu-mdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=eu-mdr-essentials) ### IVDR Essentials · From this learning path [ Regulatory General Safety and Performance Requirements(GSPRs) Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. ](/terms/gspr?from=ivdr-essentials)[ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes?from=ivdr-essentials)[ Post-Market PSUR (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. Adjacent lesson ](/terms/psur-ivdr?from=ivdr-essentials)[ Manufacturing UDI-DI vs. UDI-PI Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. Adjacent lesson ](/terms/udi-di-pi?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 5 of 9 - [IVDR Essentials](/paths/ivdr-essentials)Lesson 10 of 13 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 European Commission· 1 RAPS· 1 FDA· 1 1. [1 EUDAMED Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=eudamed) Learn in 60 seconds Card Lesson Quiz European Database on Medical Devices. - · EUDAMED is being rolled out by module. - · Mandatory use of certain modules begins as each is declared functional. Remember this Watch out: A common misconception is that EUDAMED is a single, fully functional system, when in reality it is being deployed in a modular fashion, with different functionalities becoming mandatory at different times. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Unique Device Identification(UDI) ](/terms/udi) You may also need Auto-suggested from Regulatory and shared keywords. - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [CE Mark ](/terms/ce-mark) - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Common Specifications(CS) ](/terms/common-specifications) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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