# Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
## CE Marking  
The CE marking is a mandatory requirement for selling medical devices within the Economic European Area (EEA). It plays a crucial role by certifying that these products meet all relevant EU regulations and directives and allows the free movement of products within the EEA. For manufacturers, obtaining the CE mark is a crucial legal requirement for entering the European market. For consumers, it means that the product has undergone rigorous conformity assessments, ensuring its safety and compliance with European standards [29; 30]. Marking medical devices with the CE symbol follows the general principles outlined in Article 30 of Regulation (EC) No 765/2008 and must be visibly, legibly and indelibly applied to the device or its sterile packaging [41; 42; 43]. The NBs are the entities responsible for authorizing the application of the CE marking, issuing conformity certificates and making decisions regarding their renewal or withdrawal [22; 34]. They ensure that manufacturers comply with their obligations, cooperate with national authorities and collaborate with other NBs across EU member states. If applicable, the CE marking must be followed by the identification number of the NB responsible for conformity assessment procedures [35]. Obtaining a CE mark involves several key steps, from identifying the applicable regulations for the product to affixing the CE marking, as shown in Figure 4. During this process, the manufacturer must follow a rigorous conformity assessment procedure to ensure compliance with these regulations. The first step is to determine which EU regulations and directives apply to the specific product and carefully analyze and understand the requirements that apply to it, as these requirements are the basis for ensuring product conformity. The next step is to select the appropriate conformity assessment route for the product [42; 43]. Depending on the classification class of the medical device, manufacturers must choose from several conformity assessment procedures, with NB involvement being mandatory for higher-risk devices [39]. The first procedure is the Quality Management System (QMS) and technical documentation. It is used when manufacturers implement a full QMS, covering all aspects of device development, from design to manufacturing and final inspection. NBs thoroughly assess and approve these systems to ensure compliance with regulatory standards. This process is typically used for higher-risk devices. Another procedure is the EC-Type Examination, where the NB examines a representative sample of the device to ensure it meets the essential requirements specified in the MDR. This involves rigorous evaluation and testing of the device's design to confirm it complies with the regulation's safety and performance standards. This procedure is commonly used for devices with more complex risk profiles. Then, there is the Product Conformity Verification composed of two procedures: product quality assurance and product verification. In the first one, NBs evaluate the manufacturer's production processes to ensure consistent compliance with the regulation. This includes ongoing surveillance and audits of the QMS to maintain adherence to regulatory standards over time. In the second one, NBs inspect and test individual batches of devices to confirm that the manufactured products are consistent with technical documentation and comply with regulatory requirements. This is often used when batch-by-batch verification is necessary due to the device's nature or risk [45; 46]. For Class I devices, manufacturers are only required to present technical documentation before affixing the CE marking. For Class Isp, Ims and Irs devices, the process involves limited intervention from a NB for the assessment procedure. Manufacturers have the option to submit the technical documentation with product quality assurance or with limited QMS. Moderate-risk devices, like Class IIa and IIb devices, must undergo one of the conformity assessment procedures involving a NB.