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2009, 2010, meddev - ec guidelines on medical devices
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  #1  
Old 11th January 2010, 12:55 AM
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Look! MEDDEV 2.7.1 Revision 3 Released - January 2010

Hi all,

Today, I found the revised MEDDEV 2.7.1, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, on European Commision website:
http://ec.europa.eu/enterprise/secto...s/index_en.htm

I haven't checked it well, but the current one (released in 2003) has 18 pages and this new one has 46 pages.


Reiko
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 MEDDEV 2_7_1rev_3_en_122009.pdf (221.0 KB, 135 views)

Last edited by Reiko Shiratori; 11th January 2010 at 12:59 AM. Reason: To upload the file
Thank You to Reiko Shiratori for your informative Post and/or Attachment!

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  #2  
Old 11th January 2010, 01:44 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

Quote:
In Reply to Parent Post by Reiko Shiratori View Post

Hi all,

Today, I found the revised MEDDEV 2.7.1, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, on European Commision website:
http://ec.europa.eu/enterprise/secto...s/index_en.htm

I haven't checked it well, but the current one (released in 2003) has 18 pages and this new one has 46 pages.


Reiko
Thanks for the update, the above information was posted by another user already.

Clinical Evaluation - MEDDEV 2.7.1 Rev. 3 Released - December 2009
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  #3  
Old 11th January 2010, 01:48 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

The below link for search option will be help for before posting any topic

Search
Thanks to Medsearch for your informative Post and/or Attachment!
  #4  
Old 11th January 2010, 01:56 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

Thank you, Medsearch.

I was wondering if I missed bio subbu's post...because he puts a lot of update information for us...yeah, I missed it!

Thank you, bio subbu too.


Reiko
  #5  
Old 10th March 2010, 11:35 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

Has anyone on the Cove actually gone through all 46 pages and summarized the differences introduced in Rev 3 of this document? I'm expecting there are additional requirements, but I also suspect someone has already gone through and done a critical analaysis of the actual content change...anyone....Buehler...Buehler??
  #6  
Old 15th March 2010, 05:45 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

Hello

I´m moving this thread to the CE Marking forum. Cheers!
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I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #7  
Old 5th April 2010, 04:57 AM
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Re: MEDDEV 2.7.1 Revision 3 Released

Quote:
In Reply to Parent Post by Watchwait View Post

Has anyone on the Cove actually gone through all 46 pages and summarized the differences introduced in Rev 3 of this document? I'm expecting there are additional requirements, but I also suspect someone has already gone through and done a critical analaysis of the actual content change...anyone....Buehler...Buehler??
Refer EmergoGroup’s brief summary report New Version of European MEDDEV 2.7.1 on Clinical Evaluation
Thanks to bio_subbu for your informative Post and/or Attachment!
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