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EFHSS Questions and Answers - Question Q00163

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EFHSS - Questions & Answers - Quality Assurance - Q00163
Class 1 and Class 1 sterile 		Follow Up
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From: (Italy)   Date: 31 May 2002, 12:52 [GMT]
Subject: Class 1 and Class 1 sterile

Dear Forum,

If I am a Class 1 sterile medical devices manufacturer what I must make to produce and sell a Class 1 medical device?

A. Franceschini
From: (Germany)   Date: 2 June 2002, 20:51 [GMT]
Subject: Re: Class 1 and Class 1 sterile

Hello!

My straight forward and simple advise: get a copy of EN556 "Requirements for medical devices to be labelled Sterile".

Kind regards
Klaus Hahnen
From: Wim Renders (Belgium)   Date: 3 June 2002, 18:56 [GMT]
Subject: Re: Class 1 and Class 1 sterile

Dear,

May I advise you to have also a look at the Medical Device Directive (MDD) 93/42/EEC. This directive clearly describes the requirements for medical devices and manufacturers. You can download the MDD from i.e.: www.amtac.co.uk/MDD/93-42-EEC_cnt.htm

Best regards,
Wim Renders

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