What you need to know about navigating the EU’s IVDR

The In Vitro Diagnostic Regulation (IVDR) is a regulatory framework established by the European Union (EU) to ensure the safety, performance, and reliability of in vitro diagnostic medical devices. The IVDR was introduced to replace the previous In Vitro Diagnostic Directive (IVDD) and aims to enhance patient safety and improve the effectiveness of diagnostic tests.

To obtain the CE marking under the IVDR, manufacturers must demonstrate conformity of their in vitro diagnostic devices with the regulatory requirements. The first step is to conduct a thorough assessment of the device and its intended use, which involves identifying the risk classification based on factors such as invasiveness and intended purpose. Manufacturers must then compile technical documentation that includes information on the design, manufacturing, performance evaluation, and clinical evidence supporting the device's safety and performance.

EU notified bodies play a crucial role in the implementation of the In Vitro Diagnostic Regulation (IVDR). Notified bodies are independent organizations designated by EU member states and entrusted with the responsibility of assessing and certifying the conformity of in vitro diagnostic devices with the IVDR requirements. Their role is to ensure that these devices meet the necessary standards for safety, performance, and quality.

The notified body conducts an in-depth review of the technical documentation, performs a quality management system audit, and may also carry out on-site inspections and sample testing if necessary. If the notified body determines that the device meets the requirements, it will issue a conformity assessment certificate. With this certificate in hand, the manufacturer can affix the CE marking on their in vitro diagnostic device, indicating compliance with the IVDR and allowing it to be placed on the EU market for clinical use and patient care.