Declaration of Conformity with Electrical & Electronic Medical Devices

[fialor]

Hi All,
I have come across an issue with one of the products that my company has recently taken over and I need help.

Part of the paperwork that goes out with the device is a Declaration of Conformity (DoC). I do not think this should be the case as I cannot find any requirements in 93/42/EEC that requires that the DoC should accompany the deivce, the requirement is that it must be made drawn up by the manufacturer and be "made available to the national authorities for inspection purposes...".

Any information on why this requirement is captured would be helpful.
Thanks
Fialor

 

[SteveK]

You are quite right there should be no need to send out a Declaration of Conformity with the product (for the reason you state). However, a number of our customers do request a Certificate of Conformity. I know it is a bit subtle, but there is a difference.

Steve

 

[fialor]

You are quite right there should be no need to send out a Declaration of Conformity with the product (for the reason you state). However, a number of our customers do request a Certificate of Conformity. I know it is a bit subtle, but there is a difference.

Steve

Thanks Steve.
Yes - we require a CoC instead of a DoC from our suppliers.
I shall be progressing "Project Remove the DoC" from the box of product as it is an extra line item in the packaing of products that might result in a non-conformity leading to more work.