--- title: "UDI-DI vs. UDI-PI, Definition | MedTech Terms" description: "Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. 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UDI-DI vs. UDI-PI [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply) # UDI-DI vs. UDI-PI Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A Unique Device Identifier comprises two parts: the Device Identifier ( [UDI](/terms/udi)\-DI), a static code identifying the labeler and device version, and the Production Identifier (UDI-PI), conveying lot/batch, serial, expiration, or manufacturing date. What the regulation says The [UDI](/terms/udi)\-DI (Device Identifier) is a mandatory component of a MedTech product's Unique Device Identification, identifying the specific model or version of a device. The UDI-PI (Production Identifier) captures variable production data, such as lot number, serial number, and expiration date, as required by regulations like the EU [MDR](/terms/mdr-reporting) (Article 2, Section 15) and FDA UDI Rule (21 CFR 801.3). The FDA's [Global Unique Device Identification Database](/terms/gudid) (GUDID) stores UDI-DI information, while UDI-PI data is typically found on the device label and packaging. ## What this means in practice EU [MDR](/terms/mdr-reporting) introduced the Basic [UDI](/terms/udi)\-DI as the master key for regulatory documentation in [EUDAMED](/terms/eudamed). Mismatched DI/PI assignments are a common cause of EUDAMED registration errors. ## Examples - A manufacturer assigns a new UDI-DI to a revised version of a surgical instrument that has undergone a material change, reflecting the updated device specifications. - A medical device is labeled with a UDI-PI that includes a lot number to track specific production batches in case of a quality issue or recall. - During an audit, regulators verify that the UDI-DI listed in the MedTech product documentation matches the UDI-DI on the device packaging and in the GUDID. Common pitfalls - • Assigning an incorrect UDI-DI to a device version can lead to significant regulatory non-compliance and recall issues. - • Failing to accurately link UDI-PI data to the correct UDI-DI in regulatory submissions creates data integrity problems. - • Using UDI-PI elements inappropriately, such as using a lot number field for a serial number, can result in supply chain disruptions. - • Not updating UDI-DI data when device design changes occur leads to outdated and misleading product identification. - • Disregarding the Basic UDI-DI as the primary key for device registration in EUDAMED can cause extensive administrative burdens. ## Frequently asked questions What is the primary function of a UDI-DI? The [UDI](/terms/udi)\-DI uniquely identifies the manufacturer and the specific version or model of a MedTech device. It is a fixed, non-changing component for a given device type. What kind of information does a UDI-PI convey? How do UDI-DI and UDI-PI relate to regulatory databases? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ Unique Device Identification(UDI) ](/terms/udi) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Post-Market Global Unique Device Identification Database(GUDID) FDA database holding key device identification information for all UDIs. ](/terms/gudid)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi) ### IVDR Essentials · From this learning path [ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. Adjacent lesson ](/terms/vigilance?from=ivdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=ivdr-essentials)[ Clinical & Trials Clinical Evaluation Plan(CEP) EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). ](/terms/clinical-evaluation-plan?from=ivdr-essentials)[ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. ](/terms/companion-diagnostic?from=ivdr-essentials) ### More in Manufacturing · Same category [ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 11 of 13 Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 IMDRF/GHTF· 1 1. [1 FDA UDI Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system) 2. [2 GHTF/IMDRF Process Validation Guidance Verified IMDRF/GHTF · imdrf.org ](https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf) 3. [3 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Manufacturing Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=udi-di-pi) Learn in 60 seconds Card Lesson Quiz Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI. - · EU MDR introduced the Basic UDI-DI as the master key for regulatory documentation in EUDAMED. - · Mismatched DI/PI assignments are a common cause of EUDAMED registration errors. Remember this Watch out: Assigning an incorrect UDI-DI to a device version can lead to significant regulatory non-compliance and recall issues. Related terms - [Unique Device Identification(UDI) ](/terms/udi) - [Global Unique Device Identification Database(GUDID) ](/terms/gudid) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Manufacturing and shared keywords. - [SAST and DAST ](/terms/sast-dast) - [Design Transfer ](/terms/design-transfer) - [Device History Record(DHR) ](/terms/dhr) - [MRP and ERP Systems(MRP / ERP) ](/terms/mrp-erp) - [Bill of Materials(BOM) ](/terms/bom) - [Cleanroom Classes (ISO 14644) ](/terms/cleanroom-iso-14644) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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