Drugdu.com expert's response:

When upgrading the quality system under the EU In Vitro Diagnostic Medical Device Regulation (IVDR), the following key aspects require particular attention:

I. Regulatory Understanding and Compliance

In-depth Understanding of IVDR Regulations: The IVDR imposes stricter and more specific requirements on the quality management system for in vitro diagnostic devices, covering aspects such as product classification, technical documentation, performance evaluation, and post-market surveillance. Manufacturers must thoroughly comprehend the regulatory content to ensure their quality systems align with these requirements.

Ensuring Compliance Strategies: Manufacturers should develop compliance assessment procedures to clarify the compliance of significant changes to devices covered by the system, determine applicable General Safety and Performance Requirements (GSPR), and explore processes that meet these requirements.

II. Establishment and Optimization of the Quality Management System

Building a Quality Management System Based on ISO 13485: Although IVDR does not directly mandate ISO 13485 certification, its quality management system requirements are highly consistent with and more specific than ISO 13485. Manufacturers should establish a quality management system based on the ISO 13485 standard and obtain certification to demonstrate compliance.

Optimizing Existing Quality Management Systems: Manufacturers need to conduct a comprehensive review and optimization of their existing quality management systems to ensure alignment with IVDR regulatory requirements. This includes updating documents such as the quality manual, written policies and procedures, quality procedures, quality plans, and quality records.

Strengthening Risk Management: Manufacturers must establish a risk management process in compliance with IVDR regulations to ensure product consistency, traceability, and compliance.

III. Technical Documentation and Performance Evaluation

Preparing Detailed Technical Documentation: Manufacturers are required to compile more detailed and comprehensive technical files, including technical specifications, performance evaluation reports, clinical evaluation reports, risk analysis, and management. Technical documents must meet higher transparency and detail requirements and be continuously updated throughout the device's lifecycle.

Enhancing Performance Evaluation: IVDR mandates, for the first time, the establishment of a systematic performance evaluation process covering scientific validity, analytical performance, and clinical performance. Manufacturers must conduct comprehensive performance evaluations and provide scientific literature and other evidence to support the product's performance and intended use.

IV. Post-Market Surveillance and Vigilance Systems

Establishing a Post-Market Surveillance System: Manufacturers must implement and maintain an up-to-date post-market surveillance system to proactively and systematically collect, record, and analyze information on the performance, safety, and user feedback of devices after they enter the market.

Developing and Implementing PMS and PMPF Plans: Manufacturers need to develop and execute detailed Post-Market Surveillance (PMS) plans and Post-Market Performance Follow-up (PMPF) plans (for Class C&D and some Class B devices) to continuously confirm the safety and performance of devices and identify unknown risks.

Fulfilling Reporting Obligations: Manufacturers must fulfill their medical device reporting obligations, including reporting and analyzing serious incidents, field safety corrective actions, trend reporting, and implementing corrective measures.

V. Personnel and Training

Clarifying Management Responsibilities: Manufacturers must clearly define the responsibilities of management personnel to ensure the effective operation of the quality management system.

Strengthening Employee Training: Manufacturers should enhance employee training to improve their understanding of IVDR regulations and the quality management system, ensuring that employees can operate in compliance with regulatory requirements.

VI. Monitoring Regulatory Updates and Changes

Staying Informed of Regulatory Updates: IVDR regulations may be updated and adjusted based on market conditions and regulatory needs. Manufacturers must stay informed of these updates and changes to ensure their quality systems remain compliant with regulatory requirements.

Adjusting Production and Sales Strategies: Manufacturers need to promptly adjust their production and sales strategies in response to regulatory updates and changes to ensure their products can smoothly enter the EU market.