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Technical File for CE declaration - Template or Sample of required contents

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Related Topic Tags
technical file, template, ce mark and ce marking, technical files for medical devices, contents (general term), forms and templates (general)
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  Post Number #1  
Old 4th January 2007, 08:00 PM
BRIAN777

 
 
Total Posts: 7
Thank You! Technical File for CE declaration - Template or Sample of required contents

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?

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  Post Number #2  
Old 5th January 2007, 09:45 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,546
Re: Technical File for CE declaration - Template or Sample of required contents

Quote:
In Reply to Parent Post by BRIAN777 View Post

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?
I've posted that previously. Have you searched the forums and the post attachments?
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  Post Number #3  
Old 10th January 2007, 04:26 PM
cforcier

 
 
Total Posts: 2
Re: Technical File for CE declaration - Template or Sample of required contents

There is a free guidance document on the content of technical files (NB-MED/2.5.1/Rec5).

You can find it at http://www.team-nb.org/

Regards,
Thank You to cforcier for your informative Post and/or Attachment!
  Post Number #4  
Old 10th January 2007, 06:31 PM
BRIAN777

 
 
Total Posts: 7
Re: Technical File for CE declaration - Template or Sample of required contents

I search for the information as Al indicated but was unsuccessful.

Thank you Mr. cforcier for the link. It's such a great resource.

I've come to appreciate this web site.
  Post Number #5  
Old 10th January 2007, 07:05 PM
cjbritt524

 
 
Total Posts: 4
Re: Technical File for CE declaration - Template or Sample of required contents

Table Of Contents

Section 1. General Description Of Device
Section 2. Variants
Section 3. Design Drawings And Diagrams Of Components, Sub-assemblies, Etc.
Section 4. Methods Of Manufacture
Section 5. Methods Of Sterilization And Validation
Section 6. Descriptions And Explanations Of Design Drawings, Diagrams, And Operation Of Product
Section 7. Essential Requirements
Section 8. Applicable Standards
Section 9. Hazards Analysis
Section 10. Results Of Design Calculations And Inspections
Section 11. Connection To Other Devices
Section 12. Incorporation Of Medicinal Substances
Section 13. Clinical Information
Section 14. Instructions For Use
Section 15. Previous Regulatory Clearances
Section 16. Product Accessories And Instruments
Section 17. Declaration Of Conformity
Thanks to cjbritt524 for your informative Post and/or Attachment!
  Post Number #6  
Old 11th January 2007, 10:32 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,546
Re: Technical File for CE declaration - Template or Sample of required contents

Look at the thread, Technical Files - Please explain differences and what information would be included
Thank You to Al Rosen for your informative Post and/or Attachment!
  Post Number #7  
Old 11th January 2007, 11:35 AM
jkonholm

 
 
Total Posts: 25
Re: Technical File for CE declaration - Template or Sample of required contents

Quote:
In Reply to Parent Post by BRIAN777 View Post

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?
see attachment: "Guidance Document Technical Files / Design Dossiers"

Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Non-Active Medical Devices-Products.pdf (134.3 KB, 1791 views)
Thank You to jkonholm for your informative Post and/or Attachment!
  Post Number #8  
Old 11th January 2007, 04:27 PM
BRIAN777

 
 
Total Posts: 7
Re: Technical File for CE declaration - Template or Sample of required contents

Thank you everyone for your postings. I now have valuable resources I can use use put together our TF.
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