Essentials of European Medical Device Regulatory Affairs

Module 7

• Device Labelling & IFU • Article 7 – Claims • Advertising and Promotional Claims

The Organisationfor Professionals inRegulatory Affairs

GSPR 23: Information Supplied by the Manufacturer

• Each device must have information suitable for the user to safely use the product • Label and instructions for use (IFU) 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 ISO 15223 • EN 1041 Information to be supplied with a medical device

The Organisationfor Professionals inRegulatory Affairs