UDI Creation and EUDAMED Registration
UDI Creation
Establish unique device identification enabling complete traceability and regulatory compliance.
Summary
Unique Device Identification (UDI) is a mandatory tracking system that assigns a unique identifier to your medical device, consisting of a UDI Device Identifier (UDI-DI) and UDI Production Identifier (UDI-PI). You must obtain these identifiers from approved issuing entities and register them in EUDAMED before placing your device on the EU market.Why is UDI Creation important?
UDI serves as the digital fingerprint of your medical device, enabling complete traceability throughout its lifecycle. Regulatory authorities use UDI for post-market surveillance, adverse event reporting, and market oversight. Healthcare providers rely on UDI for inventory management, patient safety, and recall management. Without proper UDI implementation, you cannot legally market your device in the EU, and you’ll face significant challenges in supply chain management and regulatory compliance.Regulatory Context
Under 21 CFR Part 830 (UDI Rule):
- UDI-DI required from FDA-accredited issuing agencies (GS1, HIBCC, ICCBBA)
- UDI-PI must include production identifiers (lot/batch, serial number, expiration date)
- GUDID database submission required for device identification
- Direct marking required for reusable devices and device packages
Special attention required for:
- Software as Medical Device (SaMD) UDI requirements and version control
- Combination products with drug/biologic components
- Kit and system-level UDI assignments
- Direct marking exemptions for certain device types
Guide
Creating your UDI involves four essential components that must be completed in sequence. Each component serves a specific regulatory purpose and requires interaction with different systems and organizations.Step 1: Obtain UDI-DI from Issuing Entity
Choose an Issuing Entity: Select from four EU-recognized organizations:- GS1 (recommended for most manufacturers) - Global standards organization
- HIBCC (Health Industry Business Communications Council) - Healthcare-focused
- ICCBBA (International Council for Commonality in Blood Banking Automation) - Blood banking focus
- IFA (Informationsstelle für Arzneispezialitäten) - German-based entity
Step 2: Create UDI-PI for Version Control
Format Requirements: Structure your UDI-PI using Application Identifiers (AI):- (01) followed by your UDI-DI
- (11) followed by production date in YYMMDD format
- (10) followed by software version identifier
Step 3: Obtain Single Registration Number (SRN)
EUDAMED Account Creation: Register at the EUDAMED portal (https://webgate.ec.europa.eu/eudamed/landing-page) as a medical device manufacturer. This requires providing detailed company information and regulatory contact details. Competent Authority Review: Submit your manufacturer registration to your chosen EU competent authority. The review process typically takes 2-5 business days, but can extend to 2 weeks during peak periods. SRN Assignment: Once approved, you’ll receive your unique SRN that identifies your company in all EU regulatory databases. This number is required for all subsequent EUDAMED registrations.Step 4: Select EMDN Code
Code Research: Use the EMDN browser (https://webgate.ec.europa.eu/dyna2/emdn/) to find the most specific code that accurately describes your device’s primary function. Avoid selecting codes that are too broad or inaccurate to your device’s actual functionality. Accuracy Priority: Choose precision over convenience. If your software performs electromyography analysis, don’t select a general “cardiac monitoring” code just because it’s closer to your search terms. The EMDN code affects regulatory classification and post-market surveillance. Documentation: Record your code selection rationale in your technical documentation, including alternative codes considered and reasons for your final selection.Integration and Registration
Basic UDI-DI Creation: Use the GS1 Basic UDI-DI calculator to generate your Basic UDI-DI from your company prefix. This identifier goes into your Declaration of Conformity and technical documentation. EUDAMED Device Registration: Complete your device registration in EUDAMED using your SRN, UDI-DI, EMDN code, and device classification information. This registration must be completed before market placement.Example
Scenario
You’ve developed a Class IIa software application for remote patient monitoring that analyzes vital signs and alerts healthcare providers to abnormal patterns. You need to create a complete UDI system before launching in Germany and France.Step-by-Step UDI Creation
Step 1: UDI-DI Registration with GS1- Purchased GS1 Smart Starter 10 package for €150
- Received company prefix: 401234567
- Assigned UDI-DI: 04012345678901
- Registration completed in 5 business days
- Software version: v1.2.3
- Release date: March 15, 2024
- UDI-PI format: (01)04012345678901(11)240315(10)v1.2.3
- Complete UDI: 04012345678901240315v1.2.3
- Registered company in EUDAMED as “VitalMonitor GmbH”
- Submitted to German competent authority (BfArM)
- Received SRN: DE-MF-000012345 after 3 business days
- Updated company registration with regulatory contact details
- Searched for “patient monitoring software”
- Evaluated codes: Z12040201 (Patient monitoring software) vs Z12040301 (Vital signs monitoring)
- Selected Z12040301 as more specific to vital signs analysis
- Documented selection rationale in technical file
- Used GS1 calculator with company prefix 401234567
- Generated Basic UDI-DI: 4012345678901
- Completed EUDAMED device registration
- Updated Declaration of Conformity with Basic UDI-DI
Final UDI Implementation
Device Label:Q&A
What is the cost of UDI registration and which entity should I choose?
What is the cost of UDI registration and which entity should I choose?
Costs vary by issuing entity and package size. GS1’s Smart Starter 10 package costs approximately €150-300 and includes 10 UDI-DIs suitable for small manufacturers. GS1 is recommended for most manufacturers due to global recognition and comprehensive support resources. The registration process typically takes 1-2 weeks regardless of the entity chosen.
How should I format my UDI-PI for software versions?
How should I format my UDI-PI for software versions?
Use Application Identifiers: (01) for UDI-DI, (11) for release date in YYMMDD format, and (10) for software version. For example: (01)04012345678901(11)240315(10)v2.1.0. Update the UDI-PI with each software version that affects safety or performance, but minor bug fixes may not require updates.
What is the purpose of the Basic UDI-DI and how do I create it?
What is the purpose of the Basic UDI-DI and how do I create it?
The Basic UDI-DI acts like a barcode for your medical device family, enabling regulatory traceability. Create it using the GS1 Basic UDI-DI calculator with your company prefix. This identifier is required in your Declaration of Conformity and EUDAMED registration, and it links all versions of your device for regulatory tracking.
How long does the EUDAMED registration process take?
How long does the EUDAMED registration process take?
The complete process involves two steps: first, obtain your SRN (2-5 business days for competent authority review), then register your device (immediate once you have all required information). The total timeline is typically 1-2 weeks, but can extend during peak periods or if additional documentation is requested.
What happens if I select the wrong EMDN code?
What happens if I select the wrong EMDN code?
Selecting an incorrect EMDN code can affect your device classification and regulatory requirements. If you discover an error, you can update the code in EUDAMED, but this may require updating other regulatory documents. Choose the most specific code that accurately describes your device’s primary function, and document your selection rationale for regulatory inspections.
Do I need new UDI identifiers for each software update?
Do I need new UDI identifiers for each software update?
The UDI-DI remains constant for your device model, but you must update the UDI-PI for each software version that affects safety, performance, or intended use. Minor bug fixes that don’t impact device functionality may not require UDI-PI updates, but document your rationale in change control records.