CE marking for In Vitro Diagnostic (IVD) devices is a mandatory requirement under the EU IVDR (2017/746), ensuring that products meet strict European standards for safety, performance, and clinical effectiveness before entering the market. It involves a risk-based classification system (Class A to D), comprehensive technical documentation including scientific validity, analytical and clinical performance data, and adherence to quality standards such as ISO 13485. Manufacturers must also implement risk management, proper labeling (including UDI), and maintain post-market surveillance activities like PMS, PMPF, and PSUR to continuously monitor product safety and performance, making IVDR compliance a critical and structured process for successful entry into the European market.