Quality Feedback from NB Audits and Technical Assessments: A Benchmark of Best Practices

In the ever-evolving landscape of medical device regulation, maintaining compliance with notified body (NB) audits and technical assessments is crucial for manufacturers. The recent PLG webinar titled “Quality feedbacks from NB Audits and technical assessment. Our benchmark of best practices” provided valuable insights into the best practices for navigating these audits and assessments. This article delves into the key takeaways from the webinar, offering a comprehensive guide for medical device manufacturers. 

Understanding the Impact of New Regulations 

Introducing new regulations has significantly impacted the quality management systems (QMS) of medical device manufacturers. Article 10 of the Medical Device Regulation (MDR) outlines the minimum requirements for manufacturers, including regulatory compliance, unique device identification (UDI), post-market activities, quality management system, communication with external parties, and clinical evaluation. The new regulations have affected all processes, necessitating a thorough review and adaptation of existing QMS. 

Systematic QMS Review 

A systematic review of the QMS is essential to identify areas impacted by the new regulations. It is important to highlight the importance of focusing on the following elements: 

1. Planned QMS Audits: Regular audits are crucial for maintaining compliance. These audits should cover all aspects of the QMS, including regulatory compliance, UDI, post-market activities, and CAPA management. 

1. Technical Documentation Review: Findings from technical documentation reviews can impact the QMS. It is essential to address these findings promptly to ensure compliance. 

1. Microbiology and Sterilization Audits: Specific audits for microbiology and sterilization have become more stringent under the new regulations. Manufacturers must ensure that their processes meet the required standards. 

1. Device Testing: Device testing may be required depending on the regulatory pathway. Manufacturers should be prepared to demonstrate compliance with the relevant standards. 

Corrective and Preventive Action (CAPA) Process 

The CAPA process is a critical component of the QMS. We need to remark the importance of differentiating between corrective and preventive actions and provided an example to illustrate this distinction. The new MDCG 2024-12 guidelines emphasize a systematic approach to CAPA, focusing on the system rather than individual cases. Manufacturers must conduct extended impact investigations to identify root causes and implement corrective and preventive actions to correct the issue analyzed and avoid recurrence of non-conformities. 

Risk Management Process 

Effective risk management is vital for ensuring the safety and efficacy of medical devices. It is important to highlight the need for a comprehensive risk management file that includes both product and process risk analyses. Key elements of the risk management process include: 

1. Full Risk Management File: This file should include all elements required by ISO 14971, as well as any additional requirements from the MDR. 

1. Dynamic Process: Risk management should be a dynamic process, with regular updates based on post-market surveillance (PMS) activities. 

1. Probability of Occurrence: Manufacturers must adapt the probability of occurrence of hazards to their real-world situation, considering factors such as the number of products on the market and the frequency of operations. 

Human Resources and Competency Management 

The competency of personnel involved in critical functions is essential for maintaining compliance. Maintaining comprehensive HR files with proof of background, experience, and regular training ensures that personnel remain competent and up-to-date with regulatory requirements. 

Validation and Verification Processes 

Validation and verification processes are crucial for ensuring the quality and safety of medical devices. Following, some key points about common non-conformities related to the validation of special processes and product verification: 

1. Protocol and Report: Manufacturers must have distinct protocols and reports for validation and verification processes. 

1. Statistical Approach: A robust statistical approach is essential for justifying sample sizes and establishing acceptance criteria. 

1. Equipment Qualification: All equipment used in validation and verification processes must be qualified and calibrated to national standards. 

Post-Market Activities 

Post-market activities, including complaint management, vigilance, and periodic safety update reports (PSUR), are critical for maintaining compliance. It is crucial to differentiate between complaints and vigilance, and ensuring timely reporting of vigilance activities. Manufacturers must also implement proactive data collection for clinical evaluations and integrate these findings into their PMS processes. 

Conclusion 

Navigating the complexities of NB audits and technical assessments requires a thorough understanding of the new regulations and a commitment to continuous improvement. By implementing the best practices discussed in the webinar, medical device manufacturers can ensure compliance, enhance their QMS, and ultimately improve the safety and efficacy of their products. As the regulatory landscape continues to evolve, staying informed and proactive is key to maintaining a competitive edge in the industry. 

References 

ProductLife Group (2024, October 10). Quality feedback from NB audits and technical assessment: Our benchmark of best practices [Webinar]. ProductLife Group. Link