UDI Compliance Assessment (FDA & EU)

Evaluate Unique Device Identification compliance for FDA (21 CFR Part 801/830) and EU MDR (Article 27), covering UDI assignment, labeling, GUDID/EUDAMED registration

MedtechHealthcare20 minutes20 questions

1. UDI Assignment & Structure

Have you selected an FDA-accredited issuing agency (GS1, HIBCC, ICCBBA)?*

21 CFR 801.40: Must use accredited agency for UDI-DI and UDI-PI

Is a unique UDI-DI (Device Identifier) assigned to each device version/model?*

801.20: UDI-DI identifies specific device model and labeler

Does your UDI include a UDI-PI (Production Identifier) with lot/serial/expiration?*

801.20: UDI-PI identifies production unit (lot, serial, expiration, manufacturing date)

Do you update the UDI-DI when device labeling or safety changes occur?*

801.20(b): New UDI-DI required for changes affecting safety, performance, or identity

2. Device Labeling

Is the UDI displayed on all device packaging levels per 801.45?*

Label UDI on device itself and each level of packaging (unit, intermediate, shipping)

Is the UDI presented in both human-readable and AIDC (barcode) formats?*

801.45(a): Plain text and automatic identification (linear or 2D barcode)

For EU MDR, is the UDI on a separate barcode from other information?*

MDR Annex VI Part C: UDI in separate AIDC carrier unless technically not feasible

Are Instructions for Use (IFU) labeled with UDI-DI (not UDI-PI)?*

801.45(c): IFU identified by UDI-DI only (production identifiers not required)

3. GUDID/EUDAMED Registration

Have you submitted device information to FDA GUDID database?*

21 CFR 830: Global Unique Device Identification Database submission required

Is GUDID data submitted before first commercial distribution?*

830.310: Publish UDI data no later than commercial distribution date

Do you update GUDID/EUDAMED data within 60 days of changes?*

830.320: Update device information when changes affect existing GUDID data

Is your device registered in EUDAMED (for EU market)?*

MDR Article 29: UDI database registration required for CE-marked devices

4. Direct Marking Requirements

For reusable devices, is UDI-DI directly marked on the device?*

801.45(d): Permanent direct marking required for reusable/reprocessed devices

Can the direct-marked UDI withstand the device processing/reprocessing cycles?*

801.45(d)(2): UDI must remain legible through sterilization, cleaning cycles

For implantable devices, is UDI on device or implant card?*

801.45(e): Class III implantables require UDI on device (if feasible) and implant card

5. Supply Chain & Verification

Do you have procedures for UDI scanning and verification at receiving?*

Best practice: Verify UDI against GUDID/EUDAMED at distribution points

Are UDI barcodes tested for scannability before distribution?*

ISO 15415/16: Verify barcode quality meets minimum grade standards

Do you provide UDI in shipping documentation (ASN, packing slips)?*

Supply chain efficiency: Include UDI in EDI transactions for traceability

6. Compliance Dates & Exceptions

Have you met the UDI compliance date for your device class?*

FDA: Class III (Sept 2014), Class II (Sept 2016), Class I (Sept 2020)

If claiming exemptions or exceptions, are they documented and justified?*

801.30: Limited exceptions for device limitations, single-use devices, etc.

Please answer all required questions to see your results