ABSTRACT
The European associations that are active in Europe and contribute to shape the regulatory environment and offer platforms for regulators and industry to communicate with each other and work on harmonization. For obtaining information about standards under review or creation and for acquisition of the published standard, the manufacturer has to apply and buy them from the standard organizations at the European level or at the national level. Consumer Education (CE) marking is affixed before marketing the product and releasing it to the European Union market for distribution or use. The Conformity Assessment Procedures correspond to modules described in the Medical Device Directives, which the manufacturer has to follow in order to affix the CE mark on the device. The lists of notified bodies can be searched on the New Approach Notified and Designated Organizations website. Depending on the medical device class, a Notified body is involved for the quality system review or Technical Documentation review.
