CE Marking is a certification mark that indicates a medical device complies with the essential quality, safety, and performance requirements outlined in the applicable Medical Device Directives in Europe. The CE Marking serves as a declaration by the manufacturer that the device meets the regulatory standards and can be legally marketed, distributed, and sold within the European Union (EU) member states.
Medical devices are classified into different risk categories based on their intended use and potential impact on patients. Devices that fall into moderate to high-risk classes must undergo a conformity assessment procedure by a Notified Body—an independent organization designated by an EU member state—to verify their compliance with the relevant directives. This assessment is a critical step in obtaining the CE Marking for such devices.
CE Marking is recognized as a symbol of product quality and safety compliance, facilitating the free movement of medical devices within the EU market. By adhering to the applicable directives and undergoing the necessary conformity assessments, manufacturers demonstrate their commitment to delivering safe and effective medical devices to healthcare professionals and patients within the European Union.
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