No,our website is designed to provide unrestricted access to eIFUs. You do notneed to register or log in. You can freely access and view the documents youneed. However, to comply with the relevant legal obligations, we may requestyou to provide us with your email address before you download the eIFU on thisWebsite for the purpose of informing you of any updates or corrective actionsrelating to the eIFU you download.

If your country or region is notlisted, it is likely that no OrbusNeich product is available for purchase inyour country or region as product availability subjects to regulatoryrestrictions in each individual country or region. You may reach out to usthrough the Contact Us page about the availability of OrbusNeich products in your country or region.

No. Please ensure you are using thedocuments that correspond to the applicable regulatory approval in your countryor region. You should not rely on any documents provided for another country orregion. 

You can find the eIFU for a specific product by first selecting the country orregion you are located on our eIFU website and then (i) clicking to select the product name (ii)entering the product REF# (reference number) or UDI-DI (Unique DeviceIdentification - Device Identifier) into the search bar. The search result willshow you the eIFU for the product you are looking for. 

If you cannot find the eIFU for a specific product you are looking for, it is likely that the product is not available for purchase in your country or region as product availability subjects to regulatory restrictions in each individual country or region or the product information you entered may be incorrect. You may reach out to us through the “Contact Us” page about the availability of OrbusNeich products in your country or region, or you may contact your local OrbusNeich representative for assistance.

Our website is regularly updated to ensure that the most current version of each eIFU is available. You may access this Website to click the most current version of the eIFU at the time you need it.

OrbusNeich has a formal process for determining when Field Safety Corrective Actions (FSCA) are necessary. Occasionally, an FSCA may include urgent revisions to prescribed instructions for use. In these cases, OrbusNeich’s process requires the distribution of a Field Safety Notice to every Health Care Provider (HCP) that has received the affected product to inform them of the revised prescribed instructions for use. Field Safety Notices are generally distributed to HCP’s through local OrbusNeich Quality and Commercial organizations. Nevertheless, for the sake of accuracy and timeliness, we still recommend you access this Website to check and download the most current version of the eIFU directly from the website each time you need it.

Yes, eIFUs are provided in the official languages used in the countries or regions in which the associated products are made available for use. You can select your country or region on our website to access the documents in the language available.

Yes, healthcare professionals are free to print the eIFU for personal use. We recommend using the latest version for any procedural reference to ensure compliance with the most current guidelines.

The instructions for use in paper form are available upon request of healthcare professionals. To request instructions for use in paper form, please reach out to your local OrbusNeich representative or email us by using the "Contact Us" page provided on this Website.

In EU, paper copies will be delivered within 7 calendar days upon request.