$247 — Standard Tier

Device Labeling Requirements Toolkit: FDA 21 CFR 801 + EU MDR Compliance

Device Labeling Requirements Toolkit — labeling requirements checklist, IFU review checklist, UDI verification, labeling change control, and artwork approval log.

Get the Toolkit — $247

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What's Included

Labeling Requirements Checklist (21 CFR 801 + EU MDR Annex I Chapter III)
Device Label Design Review SOP
Instructions for Use (IFU) Review Checklist
Labeling Change Control Form
RFID/Barcode and UDI Label Verification Checklist
Labeling Artwork Approval Log

Benefits

Dual-jurisdiction checklist covers FDA 21 CFR 801 and EU MDR Annex I
IFU review checklist catches gaps before NB or FDA reviewer does
UDI verification checklist prevents GUDID submission errors
Labeling change control form triggers proper regulatory review

Is This For You?

This toolkit is designed for teams facing these challenges:

510(k) RTA due to labeling deficiencies
Missing IFU elements causing notified body queries
UDI label errors causing GUDID rejection
Labeling changes implemented without proper regulatory review

Who This Is For

RA managers responsible for labeling complianceRegulatory affairs leads managing dual FDA/EU submissionsOperations managers overseeing label change controlQA professionals auditing labeling documentation

Frequently Asked Questions

Does this cover both FDA and EU MDR labeling requirements?

Yes, the main checklist covers both FDA 21 CFR 801 and EU MDR Annex I Chapter III labeling requirements in one document.

Is UDI included?

Yes, there is a dedicated UDI label verification checklist covering both FDA GUDID requirements and EU MDR EUDAMED registration.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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