Medical Device Declaration of Conformity Approval Requirements

Q

QualiMedd

#1
If a company has the Declaration of Conformity signed by the CEO and he subsequently changes should we reissue the Declaration of Conformity?

Jim Mackenzie
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Nope (unless you mean you no longer have a CEO).

The DOC (the same ideia can be applied to each signed documentation) should be related to the position of the individual in the company, not the person itself.
 
Q

QualiMedd

#4
Nope (unless you mean you no longer have a CEO).

The DOC (the same ideia can be applied to each signed documentation) should be related to the position of the individual in the company, not the person itself.
We actually have a new CEO

Jim Mackenzie
 

somashekar

Staff member
Super Moderator
#5
We actually have a new CEO

Jim Mackenzie
Regardless of the classification of your medical device, you must prepare an EU Declaration of Conformity (DOC) if you sell medical devices in Europe. The elements that should be included in the Declaration of Conformity include:
* Name of the device, including model number and trade name.
* Manufacturer name and address.
* Name of company quality management representative.
* Name and identification number (if applicable) of your Notified Body.
* Name, address and telephone number of your European Authorized Representative.
* Your CE Marking certificate number (if applicable).
* Your conformity assessment route to compliance. List the Annex, classification and rule number (rule number only applies to the Medical Device Directive).
* Standards that have been applied (optional)
* Name and signature of a senior management representative and date signed.


Explain to your new CEO and draw up a fresh DOC.

(Above details taken from emergogroup)

See attached for added info about DOC
 

Attachments

Q

QualiMedd

#6
Thanks, The issue is not content, we already have Declarations of Conformity, It is about reissue by the new CEO

Jim Mackenzie
 

somashekar

Staff member
Super Moderator
#7
Thanks, The issue is not content, we already have Declarations of Conformity, It is about reissue by the new CEO

Jim Mackenzie
I get you well. Based upon my experience and the information shared above I said ....
Explain to your new CEO and draw up a fresh DOC.
I also highlighted the last line to indicate the basis on which I said to draw up a fresh DOC. :)
 
R

Ron Boumans

#8
The declaration of conformity is drawn up at a certain moment. That is when de CEO signs. If the CEO changes, the declaration remains valid.

So, no need to reissue the declaration of conformity.
 

Marcelo

Inactive Registered Visitor
#9
Quote:
In Reply to Parent Post by Marcelo Antunes

Nope (unless you mean you no longer have a CEO).

The DOC (the same ideia can be applied to each signed documentation) should be related to the position of the individual in the company, not the person itself.
We actually have a new CEO

Jim Mackenzie
I meant, unless you do not have a CEO function anymore (For example, changed to president, whatever).

If it's just change of the person occupying the function, you do not need a new DOC.
 
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