The In Vitro Diagnostic Regulation (IVDR), formally Regulation (EU) 2017/746, is the European Union’s comprehensive legislative framework for medical diagnostic tests sold and used within its member states. This regulation establishes a unified set of requirements across the EU, replacing the previous Directive on In Vitro Diagnostic Medical Devices (IVDD). The primary objective of this regulatory shift is to strengthen public health protection. It ensures that all diagnostic products meet a higher standard of quality, safety, and performance before reaching healthcare providers and patients. By harmonizing rules and increasing regulatory scrutiny, the IVDR aims to build greater confidence in the reliability of diagnostic information used for health decisions.
Defining In Vitro Diagnostic Devices and Scope
An In Vitro Diagnostic (IVD) medical device is any product—reagent, instrument, software, or system—intended for use outside the human body to examine specimens like blood, urine, or tissue samples. These devices provide information concerning a person’s physiological or pathological state, congenital impairments, or predisposition to a medical condition. Examples include at-home pregnancy tests, blood cholesterol monitoring systems, and laboratory devices used to screen donated blood for viruses like HIV or Hepatitis C.
The scope of the IVDR encompasses physical test kits, laboratory equipment, and standalone software used for diagnostic purposes. This includes software that interprets complex genetic data or manages patient test results. The regulation also covers “companion diagnostics,” which are tests designed to determine if a patient is eligible for a particular therapeutic drug.
The IVDR introduced significant changes regarding laboratory-developed tests (LDTs), often called “in-house” tests, which are designed and used within a single health institution. While LDTs are still allowed, the regulation imposes strict conditions for certain high-risk tests manufactured on an industrial scale. This ensures that laboratory-developed tests meet safety and performance standards comparable to commercially manufactured devices.
The New Risk Classification System
The IVDR shifted from a list-based system to a dynamic, risk-based classification model, which directly impacts the conformity assessment process. Devices are categorized into four distinct classes—A, B, C, and D—based on the risk they pose to individual patients and public health. Classification rules consider the potential severity of harm from an inaccurate test result and the likelihood of disease spread.
Class A represents the lowest risk devices, such as non-sterile laboratory instruments. Most Class A devices can be self-certified by the manufacturer, unless the device is sold in a sterile condition. Class B devices carry a moderate individual risk but a low public health risk, serving as the default class for devices like cholesterol testing kits and self-testing devices for fertility.
Class C devices pose a high individual risk and a moderate public health risk, typically including tests for serious, non-immediately life-threatening diseases, such as most cancer markers. Class D devices represent the highest risk, involving high public health impact and high individual risk, such as tests used for screening blood donations or diagnosing highly transmissible diseases like HIV. Higher classification requires more stringent evidence and greater regulatory scrutiny before market access.
Enhanced Documentation and Conformity Assessment
The IVDR mandates a robust process for manufacturers to demonstrate compliance, determined by the device’s risk class. Central to this is the Technical Documentation, a comprehensive “evidence file” maintained throughout the device’s lifecycle. This documentation must include detailed information on the device’s design, manufacturing processes, risk management analysis, and evidence of compliance with general safety and performance requirements.
A mandatory component of the Technical Documentation is the Performance Evaluation Report (PER), which must systematically prove the device’s scientific validity, analytical performance, and clinical performance. Analytical performance refers to the device’s ability to correctly measure the intended substance, while clinical performance proves the results correlate with a specific clinical condition.
For Class B, C, and D devices, the manufacturer must undergo a conformity assessment by a Notified Body. A Notified Body is an independent, third-party organization designated by an EU member state. Their role is to audit the manufacturer’s quality management system and review the Technical Documentation, including the PER, to verify regulatory compliance. This mandatory external assessment is now required for approximately 80 to 90% of all IVDs, significantly increasing regulatory scrutiny compared to the previous directive.
Economic Operator Obligations and Post-Market Surveillance
The IVDR clearly defines the responsibilities of all parties in the supply chain, known as “Economic Operators,” holding them legally accountable for device compliance. These operators have distinct obligations to ensure that only safe and compliant devices reach the end-user.
- Manufacturers
- Authorized representatives
- Importers
- Distributors
For example, importers must verify that the device has the correct CE marking and that the manufacturer has met registration obligations before placing the device on the market.
A continuous requirement for manufacturers is establishing a rigorous Post-Market Surveillance (PMS) system. The PMS system proactively collects and analyzes performance data once the device is in use. This system detects previously unknown risks or performance issues that emerge during routine clinical practice. This information is used to update documentation and implement necessary corrective or preventive actions.
Ongoing monitoring includes vigilance, which is the mandatory reporting of serious incidents, such as patient injury or death, and Field Safety Corrective Actions (FSCAs) to the competent authorities. This data, including device registration and serious incident reports, is housed in EUDAMED, the European database on medical devices. The IVDR’s emphasis on lifecycle monitoring and shared responsibility ensures that the safety and performance of diagnostic devices are continuously maintained.