What Is EUDAMED? The European Database on Medical Devices Explained for Startups
EUDAMED is the European database for medical devices. Here is what it is, which modules are live, and what MDR Articles 33-34 require startups to register.
Category
EUDAMED, UDI & Registration
30 in-depth guides in this cluster
EUDAMED Status in 2026: What Modules Are Live and What Still Is Not
EUDAMED module status in early 2026: what is live, what is voluntary, and how the Article 34 mechanism determines when mandatory use kicks in.
How to Register Your Startup as a Manufacturer in EUDAMED
Manufacturer registration in EUDAMED under MDR Article 31 produces your SRN. Here is the step-by-step process and the data you need ready.
The Single Registration Number (SRN): How to Get Yours Under MDR
The SRN is a one-time identifier for manufacturers, authorised representatives, and importers under MDR. Here is how to obtain one and what it is used for.
Device Registration in EUDAMED: Step-by-Step for Startups
Registering a device in EUDAMED under MDR Article 29 is a sequence of specific steps. Here is the startup walkthrough with the exact data fields required.
What Is UDI? The Unique Device Identification System Under MDR
UDI is the unique device identification system under MDR Articles 27 to 29. Here is what it is, what the components mean, and what startups must do to comply.
MDR Articles 27–29: UDI Requirements Decoded for Startups
MDR Articles 27 to 29 define the UDI system, device registration, and manufacturer registration. Here is what each article requires and the sequence startups must follow.
UDI-DI vs. UDI-PI: Understanding the Two Components of Device Identification
UDI consists of two parts — UDI-DI (static device identifier) and UDI-PI (production identifier). Here is how they differ and why both matter.
Basic UDI-DI: The Master Identifier for Your Device Family
Basic UDI-DI is the master identifier for a device family under MDR. Here is what it is, how to assign it, and how it differs from UDI-DI.
How to Obtain a UDI: Choosing an Issuing Entity (GS1, HIBCC, ICCBBA, IFA)
The Commission designates four UDI issuing entities: GS1, HIBCC, ICCBBA, and IFA. Here is how to choose the right one and what each costs.
UDI Assignment for Software as a Medical Device: Special Rules
SaMD has specific UDI assignment rules under MDR. Here is when a software change requires a new UDI-DI and how to display the UDI for software.
UDI Database Registration: How to Enter Your Device Data in EUDAMED
The UDI database inside EUDAMED captures device identification data under MDR Article 28. Here is the data you must enter and how to keep it current.
UDI Carrier Requirements: Barcodes, RFID, and Human-Readable Formats
MDR requires UDI to appear on the label in both AIDC and human-readable formats. Here is what carriers are accepted and how to choose.
UDI for Kits and Systems Under MDR: How to Handle Multiple Components
Kits and procedure packs need careful UDI handling under MDR. Here is how to assign UDIs to multi-component devices and the kit-level identifier.
UDI Implementation Timeline and Transition Periods by Device Class
UDI obligations under MDR phase in by device class. Here is the implementation timeline and what is already in force in 2026.
EUDAMED Certificates Module: How Notified Body Certificates Appear in the Database
The EUDAMED certificates module makes Notified Body certificates publicly visible. Here is what it captures and what manufacturers should know.
EUDAMED Vigilance Module: Reporting Serious Incidents Through the Platform
The EUDAMED vigilance module is where serious incidents and FSCAs flow under MDR Article 87. Here is what it captures and how to report.
EUDAMED Clinical Investigation Module: Registration Requirements
The EUDAMED clinical investigation module registers studies, sponsors, and outcomes. Here is what it requires and when the obligation applies.
EUDAMED Market Surveillance Module: What Competent Authorities See
The EUDAMED market surveillance module aggregates what Competent Authorities see about your device. Here is what it captures and what that means for manufacturers.
How EUDAMED Transparency Affects Startup Strategy
EUDAMED transparency means competitors can read your SSCP, certificates and vigilance summaries. Here is how to plan your startup strategy around it.
EUDAMED and the SSCP: Public Access to Safety and Performance Data
How the SSCP reaches EUDAMED: Article 32 publication duty, Notified Body validation gate, languages, and the public access flow for clinicians and patients.
National Registration Requirements in EU Member States: What EUDAMED Does Not Replace
EUDAMED is not a one-stop register. National registration duties continue in France, Germany, Italy, Belgium and more. Here is what still applies.
DMIDS: The German Medical Device Information System for Startups
DMIDS is Germany's national medical device information system under the MPDG. How it relates to EUDAMED and what startups selling in Germany must do.
BfArM Registration: How to Register Your Medical Device in Germany
Germany registers medical devices through BfArM via the DMIDS portal alongside EUDAMED. Here is how the German national layer actually works under MDR.
ANSM Registration: How to Register Your Medical Device in France
France requires manufacturers to notify the ANSM for certain devices alongside EUDAMED. Here is how the French national registration works at general framing.
BASG/AGES Registration: How to Register Your Medical Device in Austria
Austria's BASG, operated through AGES, verifies MDR Article 31 data and runs national device duties. Here is how Austrian registration works.
How to Manage UDI Across Multiple Markets: EU, US, and Beyond
Manage UDI across EU MDR and FDA with one identifier strategy. Issuing entities, UDI-DI vs UDI-PI mapping, and a one-label-many-markets playbook.
UDI Cost and Implementation Effort: Realistic Estimates for Startups
UDI compliance has both fixed and recurring costs. Here are honest estimates of effort and cost for a MedTech startup at general framing.
The 5 Most Common UDI Mistakes Startups Make Under MDR
The five UDI mistakes that show up in almost every MedTech startup audit, with the article each one violates and the fix.
EUDAMED and UDI Compliance Checklist for MedTech Startups
The complete EUDAMED and UDI compliance checklist for MedTech startups — SRN, actor registration, Basic UDI-DI, UDI-DI, database entry, and label carrier.