MEDDEV 2.7/1 Rev 4 Appendix - A11 - Declarations of Interests

kreid

Involved In Discussions
#1
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.

I would have thought most of the evaluators of a CER will be employees of the legal manufacturer which will make fulfilling this part a creative exercise.

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

Thanks, in advance.
 
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Pads38

Trusted Information Resource
#2
From my reading of A11 I would suggest that it does not rule out company employees being involved in the writing of the CER.

Rather, it requires transparency - clear identification of who gets what.

This sort of deceleration is standard for publishing in the academic press. And it is largely aimed at any academics / clinicians involved. - Does the surgeon involved in the review of your new hip implant get a royalty on sales? or a discount?
 

kreid

Involved In Discussions
#3
Yes, I agree it makes complete sense when a company is using external clinicians to validate work.

It is just that it seems so focussed on this type of relationship and seems to ignore any other possibility and that there will also be internal people evaluating the data.

I hope it is applied with common sense.
 
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