What is IVDR?
The IVDR, or In Vitro Diagnostic Regulation, is a European Union (EU) regulation that governs the manufacture, distribution, and use of in vitro diagnostic (IVD) medical devices within the European Economic Area (EEA).
IVD devices are used for the examination of specimens derived from the human body (e.g., blood, urine, tissues) for the purpose of providing information about a patient’s health, such as diagnosing diseases or monitoring treatment. Examples of key features and aspects of the IVDR are risk classification, technical documentation and traceability.
The IVDR was introduced to improve the safety and effectiveness of IVDs, ensure a higher level of patient and user protection, and align with technological and scientific advancements in the field. Manufacturers of IVDs must adhere to the regulatory requirements outlined in the IVDR to continue marketing their devices in the EEA.
