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MEDDEV 2.7/1 rev.4 published - June 2016
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MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
MEDDEV 2.7/1 rev.4 published - June 2016
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MEDDEV 2.7/1 rev.4 published - June 2016 - Page 5


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  Post Number #33  
Old 17th April 2017, 06:25 AM
Valli

 
 
Total Posts: 25
Re: MEDDEV 2.7/1 rev.4 published - June 2016

Hi,

Can someone share the format for Declaration of Interest as per MEDDEV 2.7.1 rev.4?

Regards,
Valli

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  Post Number #34  
Old 18th April 2017, 01:00 PM
Roland chung

 
 
Total Posts: 460
Re: MEDDEV 2.7/1 rev.4 published - June 2016

Hi all,

Could anyone tell me what is the meaning of "use similar deployment methods (if relevant)" which appears in the A1 (Demonstration of equivalence)?

Thanks,
Roland
  Post Number #35  
Old 18th April 2017, 01:36 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,211
Re: MEDDEV 2.7/1 rev.4 published - June 2016

Usually, method of deployment is a term used with devices that needs to be inserted in the body such as catheters, stents, etc., related to how they are put into their necessary positions to work. But I've never seen a clear definition of that anywhere.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #36  
Old 18th April 2017, 08:28 PM
Ronen E

 
 
Total Posts: 3,736
Re: MEDDEV 2.7/1 rev.4 published - June 2016

Quote:
In Reply to Parent Post by Roland chung View Post

Hi all,

Could anyone tell me what is the meaning of "use similar deployment methods (if relevant)" which appears in the A1 (Demonstration of equivalence)?

Thanks,
Roland
FWIW look at definitions 2&3 of "deploy" here.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #37  
Old 20th April 2017, 04:18 AM
kreid

 
 
Total Posts: 56
Re: MEDDEV 2.7/1 rev.4 published - June 2016

Has anyone had discussions with their notified body on the appendix - 'A11. Information on declarations of interests' and how they will oversee this aspect?

From the text it seems to imply to me that Evaluators should be independent of the company carrying out the CER and of the device.

Also do you think the MEDDEV includes the Author of the CER as an evaluator?

Thanks, in advance.
  Post Number #38  
Old 15th May 2018, 03:20 AM
FoGia

 
 
Total Posts: 28
Re: MEDDEV 2.7/1 rev.4 published - June 2016

I haven't interacted with a NB regarding the declaration of interest but here are some thoughts:
- The MEDDEV doesn't require the clinical evaluators to be independent from the company, but obviously you would want to include independent evaluators to ensure the objectivity of the report
- There is no definition of 'author' in the MEDDEV either, the clinical evaluators are the authors of the document, and they can consist out of a team with the skills identified in the guidance
The Me
Thanks to FoGia for your informative Post and/or Attachment!
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