Draft CE Declaration of Conformity for Class I Medical Devices v3

class-1-medical-devices

Draft CE Declaration of Conformity for Class I Medical Devices with guidance notes.

This draft Declaration of Conformity is suitable for non-electrical Class I medical devices. It is an editable document and comes complete with detailed guidance notes.

 A Declaration is your legally binding statement that your equipment meets the essential requirements of the applicable Directive(s), by means of the standards listed. As such, it must only be completed and signed once these requirements have been met.

Please note:

  • Once you purchase this product, you will receive two emails, the second one containing a link to download the product. The download link will only remain active for 3 days so please make sure you download and save to your computer before this time.
  • The download is a compressed ZIP format and you will need to 'unzip' the file to see the Word and PDF documents contained.
  • VAT will be added at the checkout.
  • All rights reserved. No part of this document is to be re-sold, reproduced or transmitted in any form or by any means, electronic or mechanical, without prior written consent from Conformance Limited. 

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