Instructions for Use - Best Practice to meet all International Regulations

A

abigailt

#1
I'm looking for advice and hoping you guys can help. :confused:

We are an IVD manufacturer based in the UK who sell our products worldwide. I have recently received a request to look at eliminating? or maybe just reducing the amount of paper we include in our kits. I know that there have been more companies moving over to supplying electronically etc but wondered if people had information on published best practice or indeed something that works for them.

So I need:
1. an IFU that meets FDA requirements
2. an IFU that meets IVD Directive requirements
3. an IFU that meets language requirements within Europe
4. an IFU that can be accessed by small laboratories throughout the world i.e. Asia, South America, Middle East

Our Export Managers are keen to provide paper as they cant guarantee that an end user has computer access!

Any thoughts, comments or links gratefully received
 
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yodon

Staff member
Super Moderator
#3
Maybe I can get the ball rolling...

Don't you want (have) a single IFU that covers all requirements (language translations aside)?

My understanding (and maybe it's just US and maybe there are device class considerations so be sure to get regulatory inputs) is that you can point the customer to a website containing the IFU but have to supply a paper copy on demand if requested.
 
A

abigailt

#5
Thanks for the feedback - we do have English text that meets all regulatory requirements in terms of content. We currently pack all products (for worldwide shipment) with an English, French, German, Spanish and Czech insert as these cover our main european markets also.

For the remaining European countries with language requirements we add a country specific language translation at the point of shipping to each kit.

I am just trying to work out what is considered acceptable and best practice currently.

Thanks again
 
#6
Try this link:

www.ce-mark.com/neweu.pdf

It is a summary of all the different European country requirements including those that allow instructions in English for equiment that is only intended for professional use.

(I have no connection with that site and cannot guarantee that the information is 100% correct).
 

Rocke

Involved In Discussions
#7
We do much the same as you, but to reduce the amount of paper we stopped including all the European translations with the product. We only pack with English IFU and have the document begin with a statement in each other language pointing to our website for other language versions.
This has reduced the amount of paper considerable, but there are considerations that needs to be made before implementing this because you need to be able to supply paper in each language if the end user requests. There are guidance docuemnts on this, see e.g. MEDDEV 2.14/3 rev.1
http://ec.europa.eu/health/medical-devices/files/meddev/2_14_3_rev1_ifu_final_en.pdf"] .
Note that I am assuming your IVDs are intended for professional use.

Best regards
Camilla
 
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