$247 — Standard Tier

Labeling & IFU Toolkit: FDA 21 CFR 801 & EU MDR Compliance

Complete labeling toolkit with FDA 21 CFR 801 and EU MDR labeling requirements, IFU templates, UDI guidance, and symbol reference guides.

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Labeling Procedure (SOP)

FDA 21 CFR 801 Labeling Checklist

EU MDR Labeling Checklist (Annex I)

Instructions for Use (IFU) Template

Medical Device Symbol Guide (ISO 15223-1)

UDI Label Requirements Checklist

Labeling Change Control Form

Compliant labeling for US and EU markets

Never miss a required label element

IFU structure that meets regulatory expectations

UDI implementation guidance

This toolkit is designed for teams facing these challenges:

Labeling requirements are confusing

Different requirements for FDA vs EU

IFU content is incomplete

UDI not implemented correctly

RA professionals responsible for labelingMarketing teams creating product labelsCompanies launching in multiple markets

Often yes, due to different symbol and content requirements. Checklist highlights differences.

Yes for FDA (phased by device class) and EU MDR (EUDAMED registration).

$197

$247

$247

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

7-day money-back guarantee