Essentials of European Medical Device Regulatory Affairs - June 2020

Information Supplied by the Manufacturer

• Each device must have information suitable for the user to safely use the product • Label (23.2), pack (23.3) and instructions for use (IFU) (23.4) • 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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Symbol exercise

Symbol

Meaning

Symbol

Meaning

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Symbol exercise

Symbol

Meaning

Symbol

Meaning

“Donot reuse” ,”single use”or “useonly once” Packaging can be recycled

Date of manufacture

“Consult instructions foruse” or “Consultoperating instructions”

“Caution,consult accompanying

Manufacturer

documents”“Attention , see instructionsforuse”

Keep away from sunlight

Sterilised by ethylene oxide

Temperature limitation.Add the two temperatures

Use by

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