Essentials of European Medical Device Regulatory Affairs

ER 13.1 and 2: Information Supplied by the Manufacturer • Each device must have information suitable for the user to safely use the product • Label (ER 13.3) and instructions for use (IFU) (ER 13.6) • Information to be on the device unless this is not practicable in which case in the IFU • Instructions for use must be included in the packaging for every device. – Exception, Class I or IIa devices if they can be used safely without any instructions. • Must use symbols if claim compliance to EN 980 ISO 15223 • EN 1041 Information to be supplied with a medical device

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