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eIFU FAQs
Answers to common eIFU/ePIL questions
Q.
What are Instructions for Use (eIFU)?
A.
An eIFU is an instructions for use document in electronic form. Instructions for use provide device information about intended use, warnings, precautions, and steps on how to properly use the device.
Q.
What are Patient Information Leaflets (ePIL)?
A.
Patient Leaflets are documents containing information for patient understanding of implantable devices. Patient leaflets are available on this website to help ensure patients have access to the most current patient information when needed.
Q.
What is an Addendum?
A.
An Addendum is an additional document(s) that may be provided alongside an eIFU document version in the download document(s) modal. Please download the correct version and associated addendums.
Q.
How can I search for an eIFU/ePIL?
A.
For the most accurate and current IFU or Patient Leaflet, please search using the REF#/SKU number.
See the "Tutorials" page for step-by-step instructions and examples.
Q.
How to request a paper copy?
A.
Contact customer service by phone or email. See "Contact Support" page for relevant phone numbers and email addresses.
Paper copies will be delivered within 7 business days of the request.
Q.
What if no documents are found?
A.
Not all products have an IFU and not all products are available in all countries.
Contact customer service or your local BD representative for more information.
Q.
Why is my country not listed?
A.
The regulatory requirements of the selected country do not allow for use of electronic Instructions for Use at this time. The product will be provided with a paper copy of the Instructions for Use.
If you require a paper copy of the Instructions for Use, please contact Customer Service.
Q.
Can I use other country documents?
A.
No. Only use documents approved for the country the product is approved.
Q.
How often are documents revised?
A.
This site contains the most current version of the applicable BD product Instructions for Use and Patient Information Leaflets. All IFUs and Patient Information Leaflets are subject to revision without notice. Please verify you have the correct version of the document, and always refer back to BD's eIFU website (eIFU.bd.com) for the latest and most update to date information.
Previous versions are also available online.
Q.
How are Safety Changes communicated?
A.
A message will display alongside an IFU that has been revised for safety reasons. If a safety message is present, reference only the latest approved version of the IFU.
"Please note, there has been an update to the product due to safety reasons. Please only use the latest version of the IFU, provided on this site."