EU Regulations or Standards for instruction for use (IFU )

mpfizer

Quite Involved in Discussions
#1
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
 
#2
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
 

htcoztrk

Starting to get Involved
#4
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
 
Top