IVDR 2017/746 (In Vitro Diagnostic Regulation)
Definition
IVDR 2017/746, officially known as Regulation (EU) 2017/746, is the European Union regulation governing in vitro diagnostic medical devices (IVDs). It replaces the previous In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) and introduces more stringent requirements for the safety, performance, and clinical evidence of IVDs placed on the EU market.
Published on May 5, 2017, and fully applicable from May 26, 2022, IVDR 2017/746 aims to enhance patient safety and ensure a high level of public health protection by strengthening the regulatory framework for IVDs across the European Union.
Detailed Explanation
Purpose and Importance of IVDR 2017/746
The primary objective of IVDR 2017/746 is to harmonize the regulation of in vitro diagnostic medical devices across EU Member States and to address shortcomings identified under the previous directive. The regulation introduces a risk-based classification system, enhanced oversight by Notified Bodies, and increased requirements for clinical evidence and post-market surveillance.
Key Changes Introduced by IVDR 2017/746
- Risk-Based Classification: Devices are now classified into four risk classes (A, B, C, D) based on their intended use and potential risk to patients and users.
- Notified Body Involvement: Under IVDD, approximately 20% of IVDs required Notified Body review. Under IVDR, this figure increases to around 80%, significantly expanding oversight.
- Performance Evaluation: Manufacturers must provide scientific validity, analytical performance, and clinical performance data to demonstrate device safety and effectiveness.
- Post-Market Surveillance: Manufacturers are required to implement proactive post-market surveillance systems, including periodic safety update reports (PSURs) for higher-risk devices.
- UDI System: The Unique Device Identification (UDI) system is introduced to improve traceability and transparency of IVDs.
- EUDAMED Database: Enhanced public access to device information through the European Database on Medical Devices (EUDAMED), facilitating transparency and regulatory compliance.
Scope of IVDR 2017/746
IVDR applies to all in vitro diagnostic medical devices, including those manufactured and used within health institutions (so-called ‘in-house’ devices), companion diagnostics, genetic testing kits, and software used for diagnostic purposes. The regulation impacts manufacturers, authorized representatives, importers, distributors, and laboratories.
Classification Examples
- Class A: Instruments and specimen receptacles (e.g., pipettes, test tubes).
- Class B: Pregnancy tests, fertility tests, and general laboratory analyzers.
- Class C: Blood glucose monitoring systems, companion diagnostics.
- Class D: HIV tests, hepatitis tests, blood grouping tests.
Implementation Timeline and Transitional Provisions
Although IVDR entered into force in 2017, a transitional period was provided to allow stakeholders to adapt to the new requirements. The full application began on May 26, 2022, with staggered deadlines for different device classes and legacy products:
- Class D Devices: Transitional period until May 2025
- Class C Devices: Transitional period until May 2026
- Class B and Class A (sterile) Devices: Transitional period until May 2027
These extended deadlines were introduced through Regulation (EU) 2022/112, amending IVDR to prevent disruption in the supply of critical diagnostic products.
Impact on Stakeholders
IVDR 2017/746 significantly affects various stakeholders in the IVD industry:
- Manufacturers must invest in new clinical studies, quality systems, and regulatory resources.
- Notified Bodies face increased demand for certifications and oversight activities.
- Healthcare Institutions using in-house tests must comply with specific documentation and justification requirements.
- Patients benefit from improved safety, performance, and transparency of diagnostic devices.
