Master EUMDR 2017/745 | UDI and EUDAMED | Your Complete 10-Week Implementation Guide.

Medical Device Insights - Issue #34 April 26, 2026

Apr 26, 2026

Hi There, 👋

Welcome to Week 6 of our EU MDR Mastery series! This week we tackle the digital side of MDR: UDI (Unique Device Identification) and EUDAMED (European Database on Medical Devices). These aren't optional - they're mandatory compliance requirements that trip up many manufacturers.

`Why this series?`

EU MDR 2017/745 is mandatory for all medical devices sold in Europe. It’s the difference between market access and market exclusion, between CE marking and certification denial, between EU competitiveness.

📚 Series Progress: EU MDR Mastery

✅ Issue #29: EU MDR Introduction & Overview
✅ Issue #30: General Safety & Performance Requirements (Annex I)
✅ Issue #31: Technical Documentation (Annex II & III)
✅ Issue #32: Clinical Evaluation & PMCF
✅ Issue #33: Conformity Assessment & Notified Bodies
📍 Issue #34 (Today): UDI, Registration & EUDAMED
⬜ Issue #35: Economic Operators & Responsibilities
⬜ Issue #36: Post-Market Surveillance & Vigilance
⬜ Issue #37: Quality Management & Risk Management
⬜ Issue #38: Implementation Roadmap & Practical Guidance

📌 UDI & EUDAMED: The Digital Infrastructure

Why these exist:

MDR introduced comprehensive traceability and transparency requirements:

UDI (Unique Device Identification):

Enables device tracking throughout the supply chain.
Facilitates adverse event reporting.
Supports market surveillance.
Aids recalls and field actions.

EUDAMED (European Database on Medical Devices):

Central EU-wide database.
Public transparency.
Economic operator registration.
Device registration.
Vigilance reporting.
Market surveillance coordination.

Together: Create an interconnected system for device lifecycle management.

🎯 Part 1: UDI System

What is UDI?

Article 27(1):

“The Unique Device Identifier (UDI) system described in this Chapter shall allow the identification and facilitate the traceability of devices...”

UDI consists of two parts:

1. UDI-DI (Device Identifier):

Identifies device MODEL.
Assigned by the manufacturer.
Same for all units of the same model/version.
Changes only when the device changes.

2. UDI-PI (Production Identifier):

Identifies specific UNIT or BATCH.
Includes: Serial number, lot/batch number, software version, manufacturing/expiry date.
Varies by unit or batch.

UDI Example:

Device: CardioFlow Infusion Pump Model CF-2000

UDI-DI: (01)04567890123456
UDI-PI: (21)ABC123XYZ (11)240315 (17)260315

Combined UDI: (01)04567890123456(21)ABC123XYZ(11)240315(17)260315

Where:
(01) = Global Trade Item Number (GTIN) - UDI-DI
(21) = Serial number - UDI-PI
(11) = Production/manufacturing date (YYMMDD) - UDI-PI  
(17) = Expiration date (YYMMDD) - UDI-PI

UDI Assignment Rules

When new UDI-DI required:

Change that creates new UDI-DI:

New device model/version
Modification affecting safety/performance
Change in intended purpose
Change in materials affecting biocompatibility
Significant design change
Change in sterilization method
Change in critical labeling

Example:

CF-2000 → CF-2100 (new features) = NEW UDI-DI required
CF-2000 v1.0 → v2.0 (major software change) = NEW UDI-DI required

Changes NOT requiring new UDI-DI:

Minor software patches (security fixes, bug fixes).
Cosmetic changes not affecting function.
Label language changes.
Addition of a new language to the IFU.

Issuing Entities

The manufacturer must use an accredited issuing entity:

Recognized issuing entities:

GS1 (Global Standards 1)
HIBCC (Health Industry Business Communications Council)
ICCBBA (International Council for Commonality in Blood Banking Automation)
IFA (Information und Technik)

Most common: GS1 (uses GTIN system)

Process:

The manufacturer registers with the issuing entity.
Receives manufacturer identification number.
Assigns unique product numbers.
Generates UDI-DI.
Maintains the UDI database with the issuing entity.

UDI Carriers

UDI must appear on:

Device label:

On the device itself (if space allows)
On all levels of packaging

UDI carrier formats:

Automatic Identification and Data Capture (AIDC):

Barcode (most common)
QR code
RFID
Data Matrix

Human Readable Interpretation (HRI):

Plain text format.
Readable without a scanner.
Below or beside the AIDC carrier.

Example on label:

┌────────────────────────────┐
│  [Barcode/QR code image]   │  ← AIDC carrier
│                            │
│  (01)04567890123456        │  ← HRI format
│  (21)ABC123XYZ             │
│  (11)240315 (17)260315     │
└────────────────────────────┘

UDI Placement Requirements

Where UDI must appear:

Class III and implantable devices:

On the device itself (if practically feasible).
On each packaging level (unit, bundle, case).

Class I, IIa, IIb:

On packaging (not necessarily on the device itself, unless practical).

Special cases:

Individual packaged devices:

UDI on the package is sufficient.

Multi-unit packages:

UDI-DI on outer package.
Individual unit packages may have UDI-PI only.

Reusable devices:

Permanent UDI on the device itself.
Survives reprocessing cycles.

Software as Medical Device (SaMD):

UDI in software (about screen, metadata).
On the website/download page, if applicable.

UDI Timeline Implementation

Deadlines by class (from MDR application date):

Class III and implantable:

May 26, 2021 - UDI required

Class IIa and IIb:

May 26, 2023 - UDI required

Class I:

May 26, 2025 - UDI required

Current status (April 2026):

ALL device classes must have a UDI.
Full implementation complete.
Enforcement active.

🎯 Part 2: EUDAMED - The European Database

What is EUDAMED?

Article 33:

“The Commission shall... set up and manage the European database on medical devices (Eudamed).”

Purpose:

Centralized information on devices in the EU.
Transparency for the public and healthcare professionals.
Facilitate market surveillance.
Support the vigilance system.
Enable competent authority coordination.

Public access: Certain modules publicly accessible.

EUDAMED Modules (6 modules):

Module 1: Actor Registration

Manufacturers
Authorized Representatives
Importers
Certain distributors

Module 2: UDI and Device Registration

Basic UDI-DI
Device information
Technical documentation

Module 3: Notified Bodies and Certificates

Designated NBs
Issued certificates
Certificate status

Module 4: Clinical Investigations

Clinical investigation applications
Protocols
Results

Module 5: Vigilance and Post-Market Surveillance

Serious incident reports
Field safety corrective actions
Periodic safety update reports

Module 6: Market Surveillance

Competent authority activities
Non-compliance
Enforcement actions

Module 1: Actor Registration

Who must register:

Manufacturers:

ALL manufacturers (including Class I)
EU-based manufacturers
Non-EU manufacturers (through Authorized Rep)

Authorized Representatives:

If representing a non-EU manufacturer.

Importers:

Placing a device from a third country on the EU market.

Distributors:

Certain distributors (as defined by member states).

What to provide:

Basic information:

Legal name
Trade name (if different)
Legal form (corporation, partnership, etc.)
Address (registered, place of business)
Contact details (email, phone)
Website

Regulatory information:

Type of actor (manufacturer, importer, etc.).
Countries where active.
Device classes handled.
Medical device categories.

Single Registration Number (SRN):

Unique identifier for economic operator.
Format: BE-MF-000000001 (Country-Role-Number).
Used in all EUDAMED modules.
Appears on Declaration of Conformity.

Process:

Access the EUDAMED portal.
Create an account (email verification).
Complete the registration form.
Submit for validation.
Receive SRN (usually within days).
Update if information changes.

Module 2: UDI and Device Registration

What must be registered:

For EACH Basic UDI-DI:

Core Data Elements:

Device identification:

Basic UDI-DI.
Device trade name(s).
Device model/reference.
Classification (class and rule).
Risk class rationale.
Device with measuring function? Yes/No
Reusable surgical instrument? Yes/No

Device description:

Single-use or reusable
Sterile/non-sterile
Intended purpose (summary)
Target patient population
Target user
Principle of operation
Novelty (contains new features?)

Conformity information:

Conformity assessment route
Notified Body (if applicable)
Certificate number
CE mark affixing date

UDI information:

Issuing entity
Basic UDI-DI
Unit of use UDI-DI
Package UDI-DI (if different)

Clinical information:

Clinical investigation conducted? Yes/No
PMCF ongoing? Yes/No
Clinical evaluation summary (free text, 5000 characters)

Supply chain:

Countries where available
Critical warnings
URL for additional information

Size and identifiers:

Sizes/variants available
Additional product codes (if applicable)

Registration timeline:

Before placing on the market:

The device must be registered in EUDAMED.
Cannot CE mark and sell without registration.

Updates:

Any changes must be updated within 1 week.
New UDI-DI = new registration.

Process:

Prepare device information.
Obtain SRN (if not already).
Log into EUDAMED
Navigate to Module 2
Create a new device entry.
Enter Basic UDI-DI
Complete all required fields.
Upload the clinical evaluation summary.
Submit
Receive confirmation
Basic UDI-DI now searchable in EUDAMED

Module 3: Notified Bodies and Certificates

Managed primarily by NBs and competent authorities:

Information included:

Designated Notified Bodies
NB scope of designation
Issued certificates
Certificate status (valid, suspended, withdrawn)
Certificate holder
Devices covered by the certificate.

Manufacturer interaction:

View certificate status
Download certificate copies
Verify NB designation

Public access:

Yes - certificates publicly viewable
Transparency for customers/authorities

Module 4: Clinical Investigations

For clinical investigations in the EU:

Sponsor must register:

Clinical investigation plan.
Ethics committee approval.
Informed consent forms.
Investigator information.
Site information.
Enrollment status.
Results summary (after completion).

Multi-country investigations:

Single submission covers all EU countries.
Coordinated assessment.
Ethics committee approval is still per country.

Timeline:

Before the first patient enrolled.

Public access:

Yes - summary information public.
Transparency for patients/researchers.

Module 5: Vigilance and Post-Market Surveillance

Manufacturers use for:

Serious incident reports:

Report serious incidents to the competent authority.
Electronically via EUDAMED.
Follow-up reports.
Final reports.

Field Safety Notices (FSN):

Notify about field safety corrective actions.
Upload FSN to EUDAMED.
Track distribution.

Periodic Safety Update Reports (PSUR):

Submit PSUR electronically.
For Class IIb and III devices.

Trend reports:

Submit as required.

We’ll cover Module 5 in detail in Issue #36 (Post-Market Surveillance & Vigilance)

Module 6: Market Surveillance

Used primarily by competent authorities:

Contains:

Market surveillance activities.
Joint evaluations.
Non-compliance findings.
Corrective actions required.
Enforcement measures.

Manufacturer interaction:

May be notified of issues.
Required to respond.
Track compliance actions.

🎯 EUDAMED Public Interface

What is publicly accessible:

Anyone can search for:

Devices:

Basic UDI-DI.
Trade name.
Manufacturer.
Intended purpose.
Classification.
Certificates.
Clinical investigation information.

Economic operators:

Registered manufacturers, importers, and authorized reps.
Contact information.
Devices they place on the market.

Notified Bodies:

Designation scope
Issued certificates

Clinical investigations:

Ongoing/completed studies
Enrollment status
Summary results

Vigilance:

Field Safety Notices
Serious incident trends (aggregated)

Why it matters:

Healthcare professionals can verify device legitimacy.
Patients can research devices.
Authorities can coordinate.
Transparency builds trust.

🎯 Practical UDI Implementation

Step-by-step process:

Step 1: Select issuing entity

Most choose GS1.
Register with the issuing entity.
Obtain the company prefix.

Step 2: Assign UDI-DI

For each device model/version.
Create GTIN using company prefix + product code.
Register in the issuing entity database.

Step 3: Define UDI-PI requirements

What production identifiers are needed?
- Serial number (for individual tracking)
- Lot/batch number (for batch tracking)
- Manufacturing date
- Expiration date
- Software version
Establish data formats

Step 4: Update labels

Add UDI carrier (barcode/QR code)
Add HRI (human-readable text)
Ensure all packaging levels included
Validate barcode scannability

Step 5: Update systems

Production systems generate UDI-PI
Label printing systems include UDI
Traceability systems capture UDI
Complaint/vigilance systems reference UDI

Step 6: Register in EUDAMED

Create Basic UDI-DI entry
Complete all required fields
Submit

Step 7: Maintain

Update for any changes
New version = new UDI-DI
Keep EUDAMED current

✅ UDI & EUDAMED Checklist

UDI Implementation:

Issuing entity selected and registered
Company prefix obtained
UDI-DI assignment process documented
UDI-DI assigned for each device model
UDI-DI registered with issuing entity
UDI-PI elements defined
Label updated with UDI carrier (AIDC)
Label includes HRI format
UDI on all required packaging levels
Barcode scannability validated
Production systems generate UDI-PI
Traceability systems capture UDI

Actor Registration (Module 1):

EUDAMED account created
Economic operator registered
SRN received
SRN on Declaration of Conformity

Device Registration (Module 2):

Basic UDI-DI data compiled
Clinical evaluation summary prepared (5000 chars)
Device information entered
Classification verified
Certificate information entered (if applicable)
Registration submitted
Confirmation received
Device searchable in EUDAMED

Maintenance:

Update process defined
Responsible person assigned
Changes trigger EUDAMED update
Updates completed within 1 week
Records maintained

📊 Series Tracker

✅ Issue #29: EU MDR Introduction & Overview
✅ Issue #30: General Safety & Performance Requirements
✅ Issue #31: Technical Documentation
✅ Issue #32: Clinical Evaluation & PMCF
✅ Issue #33: Conformity Assessment & Notified Bodies
✅ Issue #34: UDI, Registration & EUDAMED (Today!)
⬜ Issue #35: Economic Operators & Responsibilities
⬜ Issue #36: Post-Market Surveillance & Vigilance
⬜ Issue #37: Quality Management & Risk Management
⬜ Issue #38: Implementation Roadmap