A medical device constituent part is combined with a drug product to form a medicinal product combination. Such products have a primary mode of action being either pharmacological, immunological or metabolic and thus, are not a medical device. Therefore, these products undergo Competent Authority review, based on the submission documentation, also called market authorization application (MAA). The Competent Authority, not in charge to review the technical part of the medical device constituent part will ask the market applicant to liaise with a Notified Body for technical review. The review of the conformity of a medical device constituent part in a Combination Product by a Notified Body is called “Notified Body Opinion”, abbreviated often as NBOp. Such a NBOp has to be submitted together with the MAA.