The In Vitro Diagnostic Regulation (IVDR) is a European Union (EU) regulation that governs the manufacture, import, and sale of in vitro diagnostic devices (IVDDs). IVDDs are medical devices that are used to test samples from the human body (e.g., blood, urine, or tissue) for the presence of specific substances (e.g., biomarkers) or to diagnose a medical condition. The IVDR, which came into effect on May 26, 2017, replaces the previous In Vitro Diagnostic Directive (IVDD) and imposes more stringent requirements on IVDDs manufacturers to ensure their safety and performance.
The IVDR requires IVDDs manufacturers to undergo a conformity assessment procedure to demonstrate that their devices meet the regulatory requirements. This procedure includes a review of the technical documentation, performance evaluation report (PER), and clinical evidence by a Notified Body. The Notified Body is an independent third-party organization designated by a EU member state that assesses the conformity of the devices with the IVDR requirements.
Performance Evaluation Report (PER)
The PER is a comprehensive document that describes the device's intended use, technical specifications, and performance characteristics. It also outlines the results of the device's performance evaluation studies, including analytical and clinical performance claims. The PER should be based on the performance evaluation plan (PEP), which outlines the studies to be conducted to generate the data required for the PER.
The IVDR requires the manufacturer to provide clinical evidence to support the device's safety and performance claims. The clinical evidence should be based on clinical performance studies (CPSs) that demonstrate the device's analytical and clinical performance in the intended population. The manufacturer must also demonstrate the device's clinical validity and clinical utility to show that it can improve patient outcomes.
Unique Device Identifier (UDI)
The IVDR requires all IVDDs to bear a unique device identifier (UDI) that identifies the device and its manufacturer. The UDI must be in compliance with the global UDI system and enable the device to be traced throughout its lifecycle.
Post-Market Surveillance (PMS)
The IVDR requires manufacturers to establish a post-market surveillance (PMS) system to monitor the device's safety and performance after it has been placed on the market. The PMS system should include a post-market performance follow-up (PMPF) plan to collect data on the device's performance and identify any adverse events or other safety issues.
General Safety and Performance Requirements (GSPRs)
The IVDR includes general safety and performance requirements (GSPRs) that apply to all IVDDs. The GSPRs cover areas such as risk management, quality management systems (QMS), labeling, and instructions for use (IFU). The manufacturer must demonstrate compliance with the GSPRs to obtain CE marking for their device.
The IVDR represents a significant change in the regulatory landscape for IVDDs manufacturers in the EU. It imposes more stringent requirements for conformity assessment, performance evaluation, and clinical evidence to ensure the safety and performance of IVDDs. Manufacturers must be aware of these requirements and develop a comprehensive strategy to comply with them to maintain their market access in the EU.