Introduction
The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vitro diagnostic (IVD) devices, emphasizing a risk-based approach and enhancing quality and safety. Technical Documentation under IVDR, as detailed in Annex II and III, is central to demonstrating compliance with the regulation. Let’s explore the comprehensive requirements:
Annex II: Technical Documentation
- Device Description and Specification
- A thorough description of the device, including its intended purpose, principles of operation, and specifications. Details about any variants or accessories should be included, as well as information on the technology and methodology used.
- Information Supplied by the Manufacturer
- This encompasses all labeling and instructions for use. It should provide clear, understandable, and precise information about the device’s safe and effective usage. This includes details on device performance, test procedures, control measures, and interpretation of results.
- Design and Manufacturing Information
- Detailed information on the design and manufacturing processes, including material composition, manufacturing processes, design drawings, and schematics. This also covers any software used in the device, highlighting software lifecycle processes and validation.
- General Safety and Performance Requirements (GSPR)
- An assessment of the device against the specific safety and performance requirements listed in Annex I of the IVDR. This involves providing evidence of compliance through testing, literature reviews, or clinical evidence, and explanations for any deviations.
- Benefit-Risk Analysis and Risk Management
- Documentation of a comprehensive risk management system, typically aligned with ISO 14971. This includes risk identification, analysis, evaluation, and control, as well as an ongoing process to monitor and manage risks throughout the device’s lifecycle.
- Performance Evaluation and Scientific Validity
- A detailed performance evaluation report, including an assessment of the scientific validity, analytical performance, and, where applicable, clinical performance of the device. This should also encompass an assessment of the device’s analytical sensitivity, specificity, and accuracy.
Annex III: Post-Market Surveillance, Vigilance, and Market Surveillance
- Post-Market Surveillance (PMS) Plan
- A robust PMS plan, outlining the systematic collection and review of data on the quality, performance, and safety of a device throughout its lifecycle. This plan should be proportionate to the risk class and appropriate for the type of device.
- Periodic Safety Update Report (PSUR)
- Required for higher-risk class devices (Class C and D), the PSUR summarizes the results and conclusions from the PMS data. This includes an analysis of the benefit-risk determination, sales volume, and an estimation of the population using the device.
- Post-Market Performance Follow-up (PMPF)
- imilar to PMCF under the MDR, the PMPF is a continuous process of updating the performance evaluation. It involves gathering and evaluating data obtained from the post-market phase to reassess the scientific validity and performance of the device.
Importance of Technical Documentation
Technical Documentation under the IVDR is vital for demonstrating compliance with the regulation. It’s a comprehensive dossier that ensures IVD devices meet the high standards set for safety and performance, facilitating market access and ongoing regulatory compliance. Notified Bodies rely heavily on this documentation for conformity assessments.
Challenges in Preparing Technical Documentation
Preparing Technical Documentation under the IVDR can be challenging due to the complexity and breadth of information required. It demands multidisciplinary input, extensive knowledge of the device, and continuous updates reflecting any changes in the device or regulatory landscape.
Best Practices
Best practices include maintaining current, thorough, and organized documentation, ensuring clarity and accessibility for regulatory review. Regular training and updates in IVDR regulatory requirements, along with a cross-functional approach involving experts from regulatory affairs, clinical, quality assurance, and other relevant fields, are essential.
Conclusion
Technical Documentation under the IVDR is a crucial element of the regulatory framework for IVD devices, ensuring they meet stringent safety and performance standards. The comprehensive nature of the documentation reflects the EU’s commitment to high levels of health protection. As the IVD landscape evolves with technological advancements and changing regulatory requirements, maintaining up-to-date and thorough Technical Documentation is key to ensuring continued compliance and safeguarding public health.