UDI Compliance & GUDID Submission Toolkit
FDA and EU MDR UDI compliance templates — from DI/PI assignment through GUDID submission, EUDAMED registration, and label verification.
What You Get
UDI Implementation Plan Template
Project plan template for implementing FDA UDI requirements across your device portfolio. Covers DI/PI assignment strategy, labeling update timeline, GUDID submission schedule, internal system updates (ERP, QMS, labeling), and the regulatory milestone checkpoints for each device type. Structured for Class I, II, and III device compliance timelines.
GUDID Submission Checklist (FDA AccessGUDID)
Complete checklist for submitting device records to FDA's Global Unique Device Identification Database. Covers all required data elements (Identifier, Device Description, Labeler, MRI Safety, Sterility, Device Counts), optional recommended elements, the submission pathway options (web, Health Level Seven), and the common error codes that delay GUDID acceptance.
Device Identifier and Production Identifier Assignment Worksheet
Structured worksheet for assigning Device Identifiers (DI) and Production Identifiers (PI) across your device portfolio. Covers DI assignment by labeling version, PI component selection (lot, serial, manufacturing date, expiration), carrier requirements by device type, and the documentation standard for your UDI master file.
EUDAMED UDI Registration and EU MDR Article 29 Checklist
EU-specific checklist for registering devices in EUDAMED under EU MDR Article 29 UDI obligations. Covers Basic UDI-DI vs UDI-DI distinction, EUDAMED actor registration prerequisites, data element mapping between FDA GUDID and EUDAMED fields, and the submission sequence that avoids the duplicate registration errors common on first EUDAMED use.
UDI Label Verification Form
Quality verification form for confirming UDI label compliance before production release. Covers barcode symbology requirements (GS1 DataMatrix, HIBCC, ICCBBA), human readable interpretation requirements, carrier placement requirements by device type, and the scan verification protocol that catches encoding errors before product ships.
UDI Database Maintenance and Annual Update SOP
Procedure for maintaining GUDID and EUDAMED records throughout the device lifecycle. Covers DI version management, labeling change triggers for new DI assignment, annual GUDID certification requirements, discontinued device procedures, and the internal change control integration that keeps your UDI databases synchronized with your actual labeled product.
Why It Works
FDA and EU MDR in one package
The GUDID submission checklist and EUDAMED registration checklist cover both systems side-by-side — manufacturers with US and EU market access can run one UDI implementation program, not two.
DI and PI assignment structured
The assignment worksheet documents the logic behind your DI/PI decisions — the document auditors ask for when they want to understand why a device change did or did not require a new DI.
Label verification before release
The UDI label verification form is the production gate check that catches barcode encoding errors and symbology placement issues before nonconforming product ships to distributors.
"UDI looks straightforward until you have 40 device configurations, 6 labeling versions, and an ERP system that was not designed for GS1. The implementation plan template is what we needed to scope the project before it started, not after it was already late."
"The EUDAMED checklist is the piece that nobody has documented well. The EU UDI requirements diverge from GUDID in ways that are not obvious, and getting the Basic UDI-DI vs UDI-DI hierarchy wrong costs weeks to unwind."
FAQ
Which devices require UDI compliance?
FDA UDI requirements apply to most medical devices distributed in the US. Class III and Class II devices have been required since 2014-2016. Class I devices and unclassified devices had a September 2022 compliance date. Prescription use only devices have a September 2023 date.
What is the difference between a Device Identifier and a Production Identifier?
The Device Identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The Production Identifier (PI) is a conditional, variable portion that identifies the production instance — lot number, serial number, manufacturing date, or expiration date depending on the device type.
What format are the documents?
All documents are editable Word and Excel templates ready for immediate use.
For informational purposes only. Not legal or regulatory advice. Legal