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EFHSS Questions and Answers - Question Q00217

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EFHSS - Questions & Answers - Packaging - Q00217
Medical Devices Instructions sheet obligatory? 		Follow Up
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From: (Italy)   Date: 19 November 2002, 16:58 [GMT]
Subject: Medical Devices Instructions sheet obligatory?

I would want to know if the sheet of the "Instructions for the use" is obligatory to enclose to all the Medical Devices of all sterile classes

Alberto Franceschini
Ferrara
From: Wim Renders (Belgium)   Date: 24 November 2002, 18:18 [GMT]
Subject: Re: Medical Devices Instructions sheet obligatory?

Dear,

Clause 13.1 of Annex I Essential Requirements of the MDD says:
"Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.

Kind regards,
Wim Renders

p.s. for the MDD see question Q00163

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