Morning,

One of our distributors in the US has requested that we include a "Certificate of Conformance" with each shipment which should
1) state conformance with the referenced (?) national and international standards.
2)That the items shipped were tested according to referenced drawings and standards.

This "Certificate of Conformance" should be lot-dependent.
The manufacture of this device is completely outsourced to a third company which is packaging and shipping directly to the distributor.

Could anyone tell me what such a "Certificate of Conformance" is? Is this something normally doe by Medical Device Manufacturers?

I´m confused as I believe any statement that the device conforms to the referenced standards are already in the "Declaration of Conformity". Why would we need to declare that each lot conforms to the given standard?



regards
t.

For information on Certificate of Conformance, you can refer HERE (http://elsmar.com/Forums/showthread.php?t=20668) and yes, it is required for medical devices too. In the referred thread, there is so much information mentioned so I will not repeat again ;)


In year 2007, there were 3 incidents where FDA gave Warning Letters (http://www.accessdata.fda.gov/scripts/wlcfm/full_text.cfm?full_text=certificate+of+conformance)

Thanks, I have already read that thread, the answer given by ScottK would answer more or less what is is, i.e. "Our product was made in accordance with your required specifications".

However, still I do not understand its legal basis. Is it somewhere in 21 CFR ?

If our contract manufacturer gives us a CoC with the generic text "This product was made in accordance with your required specifications", I do not see what extra information this provides, as we are already auditing the manufacturer.

regards
t.

Yes, there is a lot of confusion in the market. A lot of people use the terms, Declaration of Conformity, Declaration of Conformance, Certificate of Conformity or "CE certificate" interchangeable.

Please note that the CE marking directives refer to two documents:

1. the Declaration of Conformity. This document is issued by the manufacturer. The Declaration provides the information to support the CE marking. The DoC specifies the product for which the DoC is issued, with which CE directives the product complies, and with which standards the product complies (if any standards were applied). The DoC may also include references to the Notified Body that was involved (if any), or the European authorized representative of the manufacturer (if any).

2. The Certificate of Conformity: This document is relevant only in case a Notified Body is involved in the conformity assessment. The Certificate of Conformity is issued by the Notified Body. It certifies the compliance of the product with the directives and standards applied.

There is no such thing as a "CE certificate" or a Declaration of Conformance in the CE marking regulations.