EU IVDR (In Vitro Diagnostic Regulation)
Definition
The EU IVDR (In Vitro Diagnostic Regulation), formally known as Regulation (EU) 2017/746, is a European Union regulation that governs the safety, performance, and market access of in vitro diagnostic medical devices within the EU. It replaces the previous In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) and introduces a more robust, risk-based regulatory framework.
The IVDR EU regulation aims to ensure a high level of public health protection while fostering innovation and improving the transparency and traceability of diagnostic devices placed on the European market.
Detailed Explanation
Purpose and Importance of the EU IVDR
The IVDR EU regulation was introduced to address weaknesses in the previous directive and to align the regulatory framework for IVDs with the more stringent requirements of the EU Medical Device Regulation (MDR). The IVDR enhances patient safety, strengthens oversight of notified bodies, and increases the scrutiny of high-risk devices before they reach the market.
Key goals of the EU IVDR include:
- Improving the classification system using a risk-based approach.
- Enhancing clinical evidence requirements and performance evaluation.
- Introducing greater post-market surveillance and vigilance obligations.
- Ensuring better traceability through the use of Unique Device Identification (UDI).
- Facilitating transparency via the EUDAMED database.
Scope and Applicability
The EU IVDR applies to all in vitro diagnostic medical devices and accessories, including those used for:
- Diagnosis of diseases or conditions (e.g., cancer markers, infectious disease tests)
- Monitoring of medical conditions (e.g., glucose monitoring)
- Screening and predisposition analysis (e.g., genetic testing)
- Blood grouping or compatibility testing (e.g., blood typing assays)
Classification System Under IVDR
One of the major changes introduced by the IVDR EU regulation is the implementation of a new risk-based classification system. Devices are now classified into four classes based on risk: A (lowest risk), B, C, and D (highest risk).
- Class A: Low individual and public health risk (e.g., laboratory instruments)
- Class B: Moderate risk (e.g., pregnancy tests)
- Class C: High individual risk and/or moderate public health risk (e.g., tests for infectious diseases like HIV)
- Class D: High individual and public health risk (e.g., blood screening for transmissible agents)
This classification determines the level of scrutiny and conformity assessment required before a device can be marketed.
Performance Evaluation Requirements
Under the IVDR, manufacturers must conduct a comprehensive performance evaluation, which includes:
- Scientific validity: Demonstrating the association between the analyte and the clinical condition.
- Analytical performance: Assessing the ability of the device to measure the analyte accurately.
- Clinical performance: Demonstrating the ability of the device to yield results that correlate with a clinical condition.
These evaluations must be documented in a Performance Evaluation Report (PER) and updated throughout the device lifecycle.
Notified Bodies and Conformity Assessment
Most IVDs under IVDR require assessment by a notified body, especially for Class B, C, and D devices. Conformity assessment routes vary depending on classification and may include:
- Quality management system audits
- Technical documentation reviews
- Batch testing for high-risk devices
Notified bodies must be designated under IVDR and meet strict competency criteria.
Post-Market Surveillance and Vigilance
Manufacturers are required to implement and maintain a post-market surveillance (PMS) system to proactively collect and analyze data on device performance. This includes the submission of periodic safety update reports (PSURs) and trend reporting of adverse events.
Implementation Timeline
The EU IVDR entered into force on May 26, 2017, with a transition period initially ending on May 26, 2022. Due to the complexity and readiness challenges, the European Commission adopted a staggered implementation approach, extending deadlines for certain devices based on risk class and existing certifications.
Examples of Devices Affected by IVDR
- COVID-19 PCR and antigen tests (Class D)
- Genetic predisposition tests (Class C)
- Blood glucose meters (Class B)
- Laboratory equipment without measuring function (Class A)
