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“headline”: “SOP for Device Labeling and UDI Considerations in Trials”,
“description”: “This SOP describes procedures for device labeling and unique device identification (UDI) in clinical trials. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements for investigational devices, covering label creation, verification, traceability, and regulatory submissions.”,
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Published on 23/12/2025
Standard Operating Procedure for Device Labeling and UDI Considerations in Trials
| SOP No. | CR/OPS/107/2025 |
| Supersedes | NA |
| Page No. | 1 of 45 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define procedures for labeling investigational devices and applying Unique Device
Scope
This SOP applies to sponsors, investigators, CROs, device manufacturers, packaging vendors, and site staff involved in device trials. It covers creation, verification, application, reconciliation, and inspection readiness of device labels including UDI elements.
Responsibilities
- Sponsor: Defines labeling requirements and ensures global regulatory compliance.
- Device Manufacturer: Generates labels with UDI codes and trial-specific identifiers.
- Investigator/Site Staff: Verify labeling before device use at the site.
- CRA: Monitors label compliance during site visits.
- QA: Reviews and audits labeling processes and records.
Accountability
The Sponsor’s Device Quality Lead is accountable for ensuring device labeling and UDI compliance across studies. The Investigator is accountable for verifying site-level device labels prior to use.
Procedure
1. Label Creation
1.1 Labels must include trial identifier, device ID, UDI code, storage instructions, and cautionary statements.
1.2 Generate labels according to regulatory and protocol requirements.
1.3 Document creation in Label Creation Log (Annexure-1).
2. Label Application
2.1 Apply labels at manufacturer or central packaging site under controlled conditions.
2.2 Ensure barcodes/UDI codes are scannable and legible.
2.3 Record in Label Application Log (Annexure-2).
3. Label Verification
3.1 Verify label accuracy against approved text and trial-specific requirements.
3.2 Document verification in Label Verification Log (Annexure-3).
4. Label Reconciliation
4.1 Reconcile issued, applied, unused, and destroyed labels.
4.2 Maintain reconciliation records in Label Reconciliation Log (Annexure-4).
5. Label Corrections/Re-labeling
5.1 Perform re-labeling under controlled, documented conditions.
5.2 Record re-labeling activities in Re-labeling Log (Annexure-5).
6. UDI Compliance
6.1 Register device UDI in appropriate regulatory databases (FDA GUDID, EU EUDAMED).
6.2 Ensure UDI elements are linked to trial-specific records.
7. Archiving
7.1 Archive all labeling records in TMF and site ISF.
7.2 Retain according to regulatory requirements.
Abbreviations
- SOP: Standard Operating Procedure
- UDI: Unique Device Identification
- CRA: Clinical Research Associate
- QA: Quality Assurance
- PI: Principal Investigator
- TMF: Trial Master File
- ISF: Investigator Site File
- GUDID: Global Unique Device Identification Database
- EUDAMED: European Database on Medical Devices
Documents
- Label Creation Log (Annexure-1)
- Label Application Log (Annexure-2)
- Label Verification Log (Annexure-3)
- Label Reconciliation Log (Annexure-4)
- Re-labeling Log (Annexure-5)
References
- FDA – Unique Device Identification (UDI) System
- EMA/EU – EUDAMED Database and Device Labeling
- ICH E6(R2/R3) – Device Trials Labeling Guidance
- CDSCO – Device Labeling Requirements
- WHO – Medical Device Labeling and UDI Recommendations
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Device Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Label Creation Log
| Date | Label Text | Created By | Reviewed By |
|---|---|---|---|
| 01/09/2025 | For Clinical Trial Use Only – Device ID: D-2025 | Manufacturer | QA Officer |
Annexure-2: Label Application Log
| Date | Device ID | Applied By | Checked By |
|---|---|---|---|
| 05/09/2025 | D-2025 | Packaging Technician | QA Inspector |
Annexure-3: Label Verification Log
| Date | Device ID | Verified By | Comments |
|---|---|---|---|
| 06/09/2025 | D-2025 | CRA | Label compliant |
Annexure-4: Label Reconciliation Log
| Date | Issued | Applied | Unused | Destroyed |
|---|---|---|---|---|
| 10/09/2025 | 100 | 95 | 3 | 2 |
Annexure-5: Re-labeling Log
| Date | Device ID | Reason for Re-labeling | Performed By | Checked By |
|---|---|---|---|---|
| 12/09/2025 | D-2025 | Protocol Amendment Update | Technician | QA |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP