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EU Regulations or Standards for instruction for use  (IFU )
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EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
EU Regulations or Standards for instruction for use  (IFU )
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  Post Number #1  
Old 13th July 2018, 01:42 AM
mpfizer

 
 
Total Posts: 71
Question EU Regulations or Standards for instruction for use (IFU )

Hi,

I would like to know if there is any regulation or standard or guidance governing what should be described / written in an IFU for EU.

Thanks
michelle

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  Post Number #2  
Old 13th July 2018, 04:07 AM
pankracy

 
 
Total Posts: 3
Re: EU Regulations or Standards for instruction for use (IFU )

Hi Michelle,

Please check the following:
- IVD Directive (98/79/EC), Annex I, section B, clause 8.7
- IVD Regulation (2017/746), Annex I, chapter III "Requirements Regarding Information Supplied with the Device"

Regards,
Jacek
Thanks to pankracy for your informative Post and/or Attachment!
  Post Number #3  
Old 13th July 2018, 01:57 PM
Mark Meer

 
 
Total Posts: 859
Re: EU Regulations or Standards for instruction for use (IFU )

Quote:
In Reply to Parent Post by pankracy View Post

Please check the following:
- IVD Directive (98/79/EC), Annex I, section B, clause 8.7
- IVD Regulation (2017/746), Annex I, chapter III "Requirements Regarding Information Supplied with the Device"
This is assuming the device is an IVD. For non-IVD medical devices, you'll want to look at the Regulation (EU) 2017/745, Annex I, Section 23.4.
Thank You to Mark Meer for your informative Post and/or Attachment!
  Post Number #4  
Old 14th July 2018, 07:16 AM
htcoztrk

 
 
Total Posts: 11
Re: EU Regulations or Standards for instruction for use (IFU )

Hi Michelle,

You can check following documents:
- MDD 93/42/EEC Annex I ER Clause 13. Information supplied by the manufacturer
- EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
- EN ISO 15223-1: 2016 Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements
- GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices

Also I suggest you to review the IFU of equivalance demonstrated or competitor products that manufactured in or exporting to EU.

Regards,
Hatice
Thanks to htcoztrk for your informative Post and/or Attachment!
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