UDI Management SOP – EU MDR & FDA QMSR Compliant

Unique Device Identification is a mandatory regulatory requirement for medical device manufacturers placing products on the EU market under EU MDR 2017/745 and on the US market under FDA QMSR (21 CFR Part 830). UDI assignment, labeling, and database registration obligations apply across all device classes — and failure to comply with UDI requirements is an increasingly common finding during Notified Body conformity assessments and FDA inspections. Despite being a well-established regulatory obligation, UDI management remains one of the areas where manufacturers most frequently lack a documented, structured procedure within their QMS.

This UDI Management SOP gives your quality and regulatory team a complete, audit-ready framework to assign, apply, maintain, and register Unique Device Identifiers — fully aligned with EU MDR 2017/745, EUDAMED requirements, and FDA 21 CFR Part 830.

What’s Included

• P-14 UDI Management Procedure — step-by-step instructions covering UDI system selection and issuing entity requirements, UDI-DI and UDI-PI structure and assignment logic, labeling requirements for UDI carriers (linear barcode, 2D DataMatrix), EUDAMED registration workflow and data submission requirements, GUDID submission requirements for the US market, UDI change control criteria and procedures, UDI obligations for reusable devices requiring reprocessing, and record retention requirements

Who Is This For

Regulatory affairs managers, quality managers, and labeling teams at medical device manufacturers, authorized representatives, and importers placing devices on the EU market under EU MDR 2017/745 or on the US market under FDA QMSR — particularly those approaching their UDI implementation deadlines or preparing for initial MDR conformity assessment.

Why This SOP and Not Starting from Scratch

Developing a compliant UDI management procedure from scratch requires a thorough understanding of both EU MDR UDI requirements and FDA 21 CFR Part 830 — two regulatory frameworks that share common principles but differ in implementation details, database requirements, and timelines. This takes 5–8 hours of a regulatory professional’s time and carries significant risk if gaps are missed. This package is immediately usable, written by an experienced ISO 13485 Lead Auditor and former Notified Body auditor — reflecting current Notified Body and FDA expectations on what a compliant UDI management process must demonstrate at audit.

✓ Instant download after purchase ✓ Fully editable Word format ✓ Compatible with EU MDR 2017/745 and FDA 21 CFR Part 830  ✓ Used by quality teams across EU, US and Canada

Frequently Asked Questions

Q: Does this procedure cover both EU MDR and FDA UDI requirements? A: Yes. The procedure covers UDI obligations under both EU MDR 2017/745 (including EUDAMED registration) and FDA 21 CFR Part 830 (including GUDID submission) — with clear guidance on where the two frameworks align and where they differ.

Q: Does this cover EUDAMED registration requirements in detail? A: Yes. The procedure includes a structured workflow for registering devices in EUDAMED, including the data fields required for UDI-DI registration, the roles of the manufacturer and authorized representative, and the timeline obligations by device class under EU MDR.

Q: Does this procedure address UDI labeling requirements? A: Yes. The procedure covers the labeling requirements for UDI carriers including linear barcode and 2D DataMatrix format requirements, human-readable interpretation (HRI) requirements, and the specific labeling obligations for different device classes and packaging levels.

Q: How does UDI management integrate with the change control process? A: The procedure defines the criteria for determining when a device change requires a new UDI-DI to be assigned — including changes to device name, version, reference number, labeling, and sterility — and the workflow for updating EUDAMED and GUDID accordingly.

Q: In what format is the document delivered? A: The procedure is delivered in fully editable Microsoft Word (.docx) format, instantly after purchase.