IFUs and Manuals
Printed Instructions for Use (IFUs) and product manuals for medical devices — commercially printed, precisely folded, and supplied with the traceability and documentation required by FDA and EU MDR regulations.
The Instructions for Use (IFU) is a regulated document that must accompany every medical device. At PPR, we produce, print, fold, and supply IFUs and product manuals as part of your complete packaging system. From single-panel accordion-fold inserts to multi-page booklet-style manuals, we coordinate print production through our commercial printing network and manage delivery as part of your packaging supply chain.
Accordion-Fold IFUs
Multi-panel accordion (z-fold) inserts printed on lightweight coated or uncoated stock. Common configuration for IFUs that must fit inside a sterile pouch or carton without compromising seal integrity.
Booklet-Style Manuals
Saddle-stitched or perfect-bound product manuals for complex devices requiring extensive use instructions, safety information, and technical specifications.
Multilingual IFUs
IFUs printed in multiple languages on a single insert or as separate language-specific versions. Coordinated through our graphic art services team with version control documentation.
EU MDR Symbol Compliance
IFU artwork reviewed to include ISO 15223-1 symbols required under EU MDR. UDI, lot/date, sterilization, and single-use symbols properly applied per regulatory requirements.
IFU Folding & Insertion
Precision folding to specified dimensions for insertion into pouches, cartons, or trays. Automated insertion services available to integrate IFU delivery into your packaging line.
Version Control & Change Management
Document version tracking, obsolete version destruction documentation, and controlled release of new IFU versions. Supports FDA and EU MDR change management requirements.
Standard Process:
Discovery & Requirements
Device specs, sterilization method, use environment, and regulatory pathwayreviewed with your team.
Design + Development
Artwork and specification sheets provided, or new packaging concepts engineeredby our team.
Prototypes + Proposal
Prototypes available for testing and validation. Once approved, pricing and termsare determined.
Validation
IQ/OQ/PQ executed. Accelerated aging and distribution simulation testingcompleted per ISO 11607.
Final Approval + Production
Proofs made to match drawings and specifications. Validated design transferred tofull production.
Materials & Options
- Full color printing
4 color process, special print options available - Paper stock
60# uncoated (IFU standard), 70# coated, 80# gloss - Custom Binder Manuals
Customizable cover, spine and tabs - Fold Styles
Accordion, roll fold, gate fold, cross fold - Minimum font size
6pt EU MDR, 8pt recommended
Device Categories We Support
IFUs and Manuals
From artwork to finished fold, we handle the whole thing in-house. If you need it inserted into a pouch or carton, we can handle that too — so your IFU arrives with your packaging, not two weeks after it.
As fast as two week turnaround from artwork approval. We also have VMI and JIT programs that can deliver same day from your stock that we carry.
