No IFU, where the requirements would go?

K

kunal9218

Starting to get Involved
#1
#1
Hi,
I am working on a product with no IFU and product team does not want to create an IFU. My questions is: Do I put information like Disposal instructions and Serious Adverse events on the Unit label? (there will be space issues obviously). Any comments?
 
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chris1price

chris1price

Trusted Information Resource
#2
#2
Not wanting to, is generally not a good reason for not writing an IFU, You have to show that the product can be used safely without one. Having disposal instructions and Serious Adverse events suggests that this might not be the case.
 
T

tazer

Involved In Discussions
#3
#3
If they don't wish to create an IFU in paper format, they can provide it in electronic format with respecting its requirements (usability, availability, ...). Depending on the device type, certain information must be provided to the user and to technical staff such as installation, uninstallation, meaning of symbols, Warning, etc... I suggest that you check the applicable standards for mandatory content of the IFU.
 
dgrainger

dgrainger

Trusted Information Resource
#4
#4
If you need to provide the information you only have 3 options:
"...on the device itself, on the packaging or in the instructions for use..."​
(MDR Annex I 23.1)

The eIFU regs may apply if you meet the requirements but even then you still require a paper version available if a user requests a copy. (A replacement implementing act is due.)
 
S

swathi.sp

Involved In Discussions
#5
#5
Dear folks,

Inline to IEC 60601-1 clause 7.9.2, & MDD Annex I, sec 13.3, it is required to provide manufacturer address in Instruction for use, however taking in to account of training and knowledge of user, will it be suffice to give web address.? can anybody throw some light on this.
 
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