Ec certificate: The DoC is issued for all device

The DoC is issued for all device classes (I,IIa/b,III) but your Design Exam Certificate is issued to Class III devices alone. Some health authorities value a design exam certificate more than a Declaration of Conformity because it is a an official certificate from the NB. Do I need to make a separate application to obtain a Full Quality cert/ separate audit or is it part of the CE mark application? Your CE certificate ( EC certificate ) is the full quality assurance certificate . The "Annex II" and "full quality assurance" will appear on the certificate . We are using a contract manufacturer to manufacture some of our products, these products are TGA class IIa non sterile products (nebuliser and mask). Our contract manufacturer have CE marking and EC certificate to manufacture mask but they do not have EC certificate to manufacture nebuliser as... Dear all Our sales people are facing some stupid questions from customers. As you know the certificate issued by NBs for CE marking in English will always have the title as " EC Certificate " Instigated by some of the competitors our customers are saying that this is not CE certificate this is...