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Intended Use wording: What is suitable for the instruction manual?

K

Kh_Nadja

#1
Hi All!

We are looking for placing our medical device on the EU market. I am now working with instruction manual for the product.

Mentioning the product Intended Use in the manual is required by many standards.
But the Intended Use for our device is worded more as a legal statement in officialese, so, if placed in the manual as is, it might not make any sense for a lay user to whom the manual is addressed.

Is it Ok to have a simplified wording of Intended Use specifically for the purpose of including it into the user manual? Or shall there be just one and only Intended Use wording for a certain product?

Thanks in advance for the suggestions!
 
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pkost

Trusted Information Resource
#2
The instruction leaflet should be written in a way that is clear and understandable to the end user. The purpose of the instruction leaflet is to instruct the end user what the deveice is, what it can be used for, in what circumstances it is not appropriate to use and also how to use it. It is not intended as a legal document to protect the manufacturer.

I would go as far as to say that an unintelligable instruction leaflet would mean that the product does not comply with essential requirement 1!
...This shall include:
— reducing, as far as possible, the risk of use error due to the
ergonomic features of the device and the environment in which
the device is intended to be used (design for patient safety)
 
K

kgott

#3
Hi All!

We are looking for placing our medical device on the EU market. I am now working with instruction manual for the product.

But the Intended Use for our device is worded more as a legal statement in officialese, so, if placed in the manual as is, it might not make any sense for a lay user to whom the manual is addressed.

If I saw a user manual that was full of legalese I don't think I would touch the product with a barge pole. My first thought is that there is obviously something wrong with it.
 

sreenu927

Quite Involved in Discussions
#4
You must put the same intended use statement that you have used in your regulatory submissions.
In the instructions for use, as steps or description - you may simplify it.

Else, you can contact your Notified Body!

Regards,
Sreenu
 
#5
When discussing Intended Use the strict legal requirements that are part of a US FDA submission (Intended Use / Indications for Use) can confuse the situation.

As this is in the EU section of the forums we can, perhaps, restrict ourselves to discussion on Intended Use for EU use. On looking at Annex 1 of the MDD clause 13 - Information supplied by the manufacturer - you will find that Intended Use is not actually used. At 13.4 we have
If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use.
I'm sure that most manufacturer's would like to have Instruction Manuals that can satisfy requirements on both sides of the Atlantic. We get around this by having a "Regulatory Statements" page that includes the US Intended Use and Indications for Use statements and then have the actaul Instructions that (hopefully!) make sense to our users.
 
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