EU MDR and IVDR UDI Requirements Guide: Basic UDI-DI, EUDAMED, and Labeling Rules

The European Union’s MDR (Medical Device Regulation - Regulation (EU) 2017/745) and IVDR (In Vitro Diagnostic Medical Devices Regulation - Regulation (EU) 2017/746) mandate a comprehensive Unique Device Identification (UDI) system to guarantee end-to-end traceability of healthcare products across the single market.

Unlike the US FDA UDI framework, the European regulatory regime introduces unique requirements including the Basic UDI-DI structure and compulsory registration within EUDAMED (European Database on Medical Devices). This guide details EU MDR/IVDR UDI rules, packaging symbol requirements, and step-by-step label creation in UDImaker.

1. The EU 3-Tier UDI Hierarchy: Basic UDI-DI, UDI-DI, and UDI-PI

The European UDI architecture relies on three distinct operational levels:

A. Basic UDI-DI (GMN)

• Unique to EU Regulations: Identifies a group/family of medical devices sharing the same intended purpose, risk class, and essential design attributes.
• EUDAMED Access Key: Main key referenced on the EU Declaration of Conformity (DoC), Technical Documentation, CE Certificates, and Free Sale Certificates (FSC).
• CRITICAL RULE — NOT ON THE PACKAGING LABEL: The Basic UDI-DI is NEVER printed on the product label or encoded into a barcode (AIDC). It exists strictly for regulatory administration and documentation.
• Under GS1 standards, the Global Model Number (GMN) includes two mandatory check characters within its maximum total length of 25 characters.

B. UDI-DI (Device Identifier)

• The fixed identifier specific to a device model and packaging level.
• MUST APPEAR ON THE LABEL: Encoded into the barcode (AIDC) and printed in human-readable interpretation (HRI).
• Represented as a GTIN (Global Trade Item Number - AI 01) under GS1 standards and linked to the Basic UDI-DI in EUDAMED.

C. UDI-PI (Production Identifier)

• The variable production control data:
• Expiration Date: GS1 Application Identifier (17)
• Manufacturing Date: GS1 Application Identifier (11)
• Lot / Batch Number: GS1 Application Identifier (10)
• Serial Number: GS1 Application Identifier (21)
• Software Version: GS1 Application Identifier (8012) where applicable. UDImaker's built-in GS1 fields do not include this AI; do not substitute it into a different field.

2. Mandatory Dual Carrier: AIDC and HRI

Under Annex VI of MDR and IVDR, UDI data must be present on device packaging in two formats:

1. AIDC (Automatic Identification and Data Capture): An appropriate machine-readable carrier under the issuing entity's system. GS1 DataMatrix is the workflow covered here; the regulations do not prescribe this single symbology for every device.
2. HRI (Human Readable Interpretation): Legible text line displaying GS1 Application Identifiers in parentheses:

(01)09506000134352(11)260826(17)290826(10)LOT9876(21)SN54321 (illustrative data only).

3. EUDAMED Database Registration

The European Commission states that use of the UDI/Devices module became mandatory on 28 May 2026. Apply the current device-specific and transitional rules, including the separate treatment of legacy devices. See the Commission's UDI/Device registration page.

• Manufacturers obtain a Single Registration Number (SRN).
• Basic UDI-DI attributes are uploaded, and corresponding UDI-DI (GTIN) packaging variants are linked beneath it.
• Dynamic production data (UDI-PI like lot numbers or expiry dates) is NOT uploaded to EUDAMED.

4. ISO 15223-1 & EU Packaging Symbols

EU regulations favor internationally harmonized symbols to eliminate multilingual text clutter:

• MD Symbol: Symbol 5.7.7 "Medical Device" under EN ISO 15223-1:2021.
• IVD Symbol: In Vitro Diagnostic Medical Device symbol.
• CE Mark + Notified Body ID: For Class Is, Im, Ir, Class IIa, IIb, III (MDR) and Class B, C, D (IVDR), the CE mark must be accompanied by the 4-digit Notified Body ID (e.g., CE 0123).
• Authorised Representative: Include the required representative details where applicable; select symbols and wording using the current label requirements and referenced standards.
• ISO Standard Symbols: Manufacturer factory icon, Hourglass (use-by date), LOT, REF, and Consult IFU.

5. Step-by-Step EU MDR / IVDR Label Design in UDImaker

Use UDImaker to prepare artwork for your quality and regulatory review. The editor does not allocate identifiers, submit device records or establish MDR/IVDR compliance:

Step 1: Set Millimeter Dimensions

Specify your label stock dimensions (e.g., 100 mm x 50 mm).

Step 2: Generate GS1 DataMatrix

Select GS1 DataMatrix and enter GTIN (01), Mfg Date (11), Exp Date (17), Lot (10), and Serial (21). FNC1 separators (represented in reader output as ASCII 29) and HRI text are generated automatically.

Step 3: Add Regulatory & ISO Symbols

Insert the MD (or IVD) symbol, CE Mark with Notified Body ID, EC REP details, and ISO 15223-1 icons.

Step 4: Export and review

Download SVG for vector artwork or PDF/PNG for a 300 DPI raster result. Print at actual size on the intended material. Review the label, applicable database record and symbol quality separately; a successful decode is not a conformity assessment.