Harmonized Standards on Medical Device IFU (Instructions for Use)

O

ODISSEAS

Hello friends,

just a question. For a given Im class device, I guess that printing on IFU some paragrapf stating wich harmonized standard applicable to its group has been met, although seems redundant, will not represent a non-conformity. Could you confirm my point of view?.

Thanks.
 
A

arios

I don't believe there is a non-conformance provided there is no misleading or contradictory information
 
M

MIREGMGR

I agree with Arios.

Why, though, would you put that kind of information in the IFU, rather than in your marketing literature where the multi language requirements don't apply?
 
G

GPjeri

Ditto to previous reply. Why would you put the standards on your IFU and set yourself up for more labeling changes? Standards should be on your Declaration of Conformity anyway, and ERC, and when revised both of these as well. The right symbols need to be on your IFU of course.
 
O

ODISSEAS

Hi,

thank you for suggestions and requestioning. It was more a regulatory than standards related issue. Our company acts only as importer, but although CE marked, authority will evaluate again IFU and labelling manufactured abroad.
 

mpfizer

Involved In Discussions
Are there any ISO or ASTM standards for IFU ie wht should appear on an IFU ?

Any guidelines?

Thanks
michelle
 
L

locutus

Unless it is required to state standards for compliance in the IFU, i.e. electrical safety standards or product specific standards such as for chemicals, then you should not need to list them. I have never seen an IFU listing standards like 10993 or 14971 - but standards like 60825 or 60601-1-2, yes.
 

Ronen E

Problem Solver
Moderator
BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

ISO/IEC Guide 37:2012 - Instructions for use of products by consumers (browse a draft here)

IEC 82079-1:2012 - Preparation of instructions for use -- Structuring, content and presentation -- Part 1: General principles and detailed requirements

ASTM standards are typically concerned with test methods, so probably less relevant.

If your context is the EU, have a look at the MDD’s Annex I s. 13. It’s quite prescriptive regarding the contents of the IFU.
 
Last edited:
Top Bottom