Hello Anon,
Recently, well almost a year ago now, Brazil updated their medical device regulations RDC 751/2022 which does (and still) require all medical devices to have Instructions for Use (IFU) - there are some exceptions for Class I and Class II where safety of the device is not compromised having simple or no instructions. Regarding, electronic IFUs or eIFUs, there are a number of requirements now included such as an identification on the device where the eIFU can be located, how to locate and know the correct version of IFU on the internet is being used, freely available, and a few others. Similar to many other countries, eIFUs can not be used for at home devices or devices used by lay-persons - so basically professional use only. The In Vitro Diagnostic Medical Devices (IVD) regulation in Brazil was just recently updated RDC 830/2023 (the RDC 751 was updated to align with international standards and the EU) coming into force this June 2024. However, use of eIFUs have been around for a long time in Brazil going back to 2012 with the IN 4 regulation published for non-printed formatting of instructions; this is now incorporated into the regulation itself. To answer your question, it would be allowed as long as the IVD device is for professional use only. If the Class II is for lay-person use or point-of-care, then eIFU most likely would be prohibited.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 15-Feb-2024 15:24
From: Anonymous Member
Subject: Brazil IVD Labelling Requirements
This message was posted by a user wishing to remain anonymous
Hello Everyone!
I'm investigating to find out whether a physical copy of the Instructions for Use (IFU) is required to be shipped with an IVD Class II in Brazil?
Is it possible to only have the electronic IFU on the company website? Thank you!!