IFU / DFU Documents
IFU (Instructions For Use) and DFU (Directions For Use) documents are the instructions that must legally accompany medical device and pharmaceutical packaging. Content accuracy, language completeness and version control sit at the centre of this production.
Every revision is recorded with a new version number; which version was used in which lot must remain traceable. Text comparison and a sample archive maintain that traceability throughout production.
Key features
- Version controlEvery revision is numbered and matched to its lot.
- Text verificationThe print file is compared character by character with the approved file.
- Symbol standardsMedical symbols printed at correct size and clarity.
- Multilingual layoutThe language sets required for the EU market are planned in one document.
Where is it used?
IFU / DFU Documents applications are most often implemented in the following areas:
- Medical device packaging
- Sterile single-use products
- In vitro diagnostic kits
- Implants and surgical sets
- In-carton pharmaceutical instructions
- Dental products
Technical specifications
| Paper | 28 – 70 g/m², options suitable for sterile environments |
|---|---|
| Tracking | Version number, revision date, lot record |
| Quality | Text comparison, legibility control |
| Packing | Count-controlled packing, line feeding format |
Let us start with a sample. Before series production we print a digital sample and recommend testing it on your own filling line where possible. Folding structure, legibility and adhesive performance are then verified before production starts.