Procedure

4.1 Understanding UDI Labeling Requirements
4.1.1 UDI System Overview
– The UDI system requires that medical devices are labeled with a unique identifier to improve traceability, facilitate recalls, and enhance safety. The UDI consists of two parts:
– Device Identifier (DI): A unique identifier for a specific device model or version.
– Production Identifier (PI): Information about the specific production unit, such as lot number, serial number, expiration date, and manufacturing date.

4.1.2 Regulatory Requirements for UDI Labeling
– Ensure compliance with the UDI labeling requirements as outlined in:
– FDA 21 CFR Part 830: UDI system for medical devices sold in the United States.
– ISO 13485: Medical device quality management systems.
– EU MDR (Regulation (EU) 2017/745): Medical device regulations for the European market.
– Global UDI Database (GUDID): FDA database for submitting UDI information for devices sold in the U.S.

4.1.3 UDI Label Content
– UDI labels must include:
– Device Identifier (DI): Identifies the specific device model and manufacturer.
– Production Identifier (PI): Contains information such as batch or lot number, expiration date (if applicable), and serial number.
– Human-readable UDI: Displayed in human-readable format along with the machine-readable code.
– Machine-readable UDI: Displayed as a barcode, QR code, or RFID tag that can be scanned electronically.

4.2 Assigning UDI Codes
4.2.1 UDI Code Assignment
– UDI codes must be assigned to all medical devices according to the requirements of the regulatory authorities. This process typically involves:
– Obtaining a UDI Issuer ID: Work with a recognized UDI issuer, such as GS1 or HIBCC, to assign a unique UDI.
– Generating the DI: Assign a unique device identifier for each device model or version.
– Generating the PI: Include production-specific information like lot or batch numbers, serial numbers, and expiration dates in the UDI.

4.2.2 UDI Submission to Regulatory Databases
– Submit UDI information to the appropriate regulatory database, such as:
– FDA GUDID: For U.S.-marketed devices, submit UDI data to the FDA’s Global UDI Database.
– European UDI Database (EUDAMED): For EU-marketed devices, submit UDI data to the EUDAMED database.

4.2.3 UDI Labeling for Combination Products
– If a device is part of a combination product (e.g., a drug-device combination), ensure that UDI labeling is compliant with both the FDA’s and other regulatory authorities’ specific guidelines for combination products.

4.3 UDI Label Design and Placement
4.3.1 UDI Label Design
– Ensure that UDI labels are designed to be easily scannable and include the following:
– Readable Text: Ensure that the human-readable portion of the UDI label is legible.
– Barcode/QR Code: Use machine-readable codes such as 1D or 2D barcodes, QR codes, or RFID tags for easy scanning.
– Placement: Place the UDI label on the packaging or device in a location that is easily visible and accessible.

4.3.2 Placement Requirements
– UDI labels must be placed on:
– Primary Packaging: Directly on the device packaging if the device is sold in individual units.
– Secondary Packaging: For products shipped in bulk or cases, the UDI should appear on the secondary packaging, such as cartons or shipping boxes.
– Device Itself: If required by regulations, the UDI must also appear on the device itself (e.g., surgical instruments).

4.3.3 UDI Label Placement for Sterile Devices
– For sterile medical devices, ensure that the UDI label is applied in a way that ensures its integrity is maintained, and the label remains legible throughout the product’s shelf life.

4.4 Verification and Compliance
4.4.1 Verifying UDI Label Accuracy
– Before labeling devices, the following verification steps should be taken:
– Verify UDI Information: Ensure that the UDI code on the packaging matches the one registered in the relevant regulatory database (e.g., FDA GUDID, EUDAMED).
– Check for Correctness of Production Identifiers: Ensure that the batch number, serial number, expiration date, and other production-specific details are accurately printed on the label.

4.4.2 UDI Labeling Audit
– Conduct periodic audits of the labeling process to ensure compliance with UDI requirements:
– Internal Audits: QA and Regulatory Affairs should regularly audit the labeling process to confirm that UDI labels are applied properly.
– External Audits: Regulatory authorities may conduct inspections and audits of the labeling process to ensure compliance with UDI requirements.

4.4.3 Corrective Actions for UDI Labeling Issues
– If discrepancies are found during verification or audits, the following actions should be taken:
– Correct the Labels: Correct any errors in UDI codes or label placement.
– Retesting: Retest the product and label to ensure that the updated labels meet all regulatory requirements.
– Corrective and Preventive Actions (CAPA): Investigate the root cause of the labeling error and implement preventive measures to avoid future mistakes.

4.5 Documentation and Record Keeping
4.5.1 UDI Labeling Records
– Maintain records of all UDI labeling activities, including:
– UDI codes assigned to each product.
– Verification and validation records for UDI labeling.
– Documentation of the submission of UDI data to regulatory databases (e.g., GUDID, EUDAMED).
– Approval records from QA and Regulatory Affairs teams.

4.5.2 Record Retention
– Retain all UDI labeling records for at least five years or as required by regulatory authorities, to ensure traceability and compliance during inspections or audits.

4.6 Compliance and Regulatory Requirements
4.6.1 Compliance with UDI Regulations
– Ensure that UDI labeling complies with the following regulations:
– FDA 21 CFR Part 830: Unique Device Identification System for medical devices in the U.S.
– ISO 13485: Quality Management Systems for medical devices.
– EU MDR (Regulation (EU) 2017/745): UDI requirements for devices sold in the EU.
– Global UDI Database (GUDID): Database for storing UDI information for devices sold in the U.S.

4.6.2 Regulatory Inspections and Audits
– Provide UDI labeling records during regulatory inspections or audits, ensuring compliance with all applicable regulations. This includes:
– UDI label samples.
– Documentation of UDI data submissions to regulatory databases.
– Evidence of corrective actions taken for labeling errors.

5) Abbreviations

– UDI: Unique Device Identification
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization

6) Documents

– UDI Labeling Approval Records
– UDI Label Verification Reports
– UDI Submission Documentation
– Corrective Action Logs

7) Reference

– FDA CFR Title 21, Part 830: Unique Device Identification System
– ISO 13485: Medical Devices – Quality Management Systems
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
– Global UDI Database (GUDID)

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: UDI Labeling Approval Log Template

Date	Device Name	UDI Code	Label Verified By	Approval Status
DD/MM/YYYY	Device ABC	1234567890	QA Team	Approved

Annexure 2: UDI Labeling Error Report Template

Date	Error Description	Corrective Action Taken	Responsible Person	Follow-up Actions
DD/MM/YYYY	Incorrect serial number on label	Reprinted labels with correct serial number	John Doe	Recheck label accuracy