Performance Evaluation for In Vitro Diagnostics (IVDs)

Performance Evaluation for In Vitro Diagnostics (IVDs)

At LFH Regulatory, we specialise in comprehensive performance evaluations to ensure your IVD meet all regulatory requirements and perform optimally in the market. Our expert team is dedicated to helping you navigate the complex regulatory landscape efficiently and effectively.  

Why performance evaluation matters  

Performance evaluation is a critical step in validating the  safety and performance of your IVD. This process ensures that your device performs as intended and meets the IVDR requirements and all necessary regulatory standards, ultimately safeguarding patient safety and product efficacy.  

Our Performance Evaluation Services

  • Regulatory Expertise: Our team stays abreast of the latest regulations, ensuring your performance evaluation aligns with current standards and IVDR requirements. 
  • Detailed Analysis: We conduct thorough and precise evaluations to validate your device’s safety and performance, covering all necessary aspects to support regulatory submissions.  
  • Timely Delivery: With our efficient methodologies, we help you meet deadlines without compromising on quality.  
  • Comprehensive Support: From initial testing to final report submission, we provide continuous support and guidance throughout the evaluation process.  

Key Aspects of Performance Evaluation

Our adept team of consultants offers a comprehensive suite of services tailored to facilitate your regulatory needs. We support you throughout the medical device lifecycle, from the initial design stages of early testing documentation to market launch and ongoing lifecycle management. Our services encompass a wide range of crucial elements in the regulatory landscape:  

Regulatory Requirements

We ensure your performance evaluation meets all regulatory requirements under the EU  IVDR. This includes a comprehensive assessment and analysis of data to establish or verify the scientific validity, analytical performance, and clinical performance of your device. Our team meticulously reviews all regulatory requirements, guidelines and standards  ensuring your evaluation process is compliant, preventing delays and ensuring a smooth path to market entry.

Systematic Approach

Our structured and systematic process includes planning, data collection, and rigorous analysis. We begin with a detailed Performance Evaluation Plan (PEP) that outlines objectives, methodologies, and timelines, ensuring every aspect of the evaluation is covered comprehensively. This systematic approach guarantees that no detail is overlooked, providing a solid foundation for your performance evaluation report.  

Performance Evaluation Plan (PEP)

The PEP is designed to enable a thorough and accurate performance evaluation. It covers:  

  • Intended purpose and performance specifications  
  • Identity of the analyte or marker  
  • Certified reference standards or measurement procedures  
  • Target patient groups and related indications  
  • Identification of the general safety and performance requirements (GSPRs) that require support from the clinical evidence 
  • Methodology and statistical tools for assessment for the examination of the analytical and clinical performance of the device 
  • Description of the state of the art and relevant standards  
  • Parameters for benefit risk ratio acceptability  
  • Development phases, milestones, and validation testing  
  • Details for software as a medical device (if applicable)  
  • Post-market performance follow-up (PMPF) planning  

Performance Evaluation Report (PER)

The PER compiles the results of the performance evaluation and verifies conformity with the relevant GSPRs which includes:

  • Scientific validity report  
  • Analytical performance report  
  • Clinical performance report  

Ongoing Assessment:

Continuous performance evaluation is essential for maintaining compliance and ensuring ongoing device safety, effectiveness and perfomance.

We support ongoing performance monitoring and post-market surveillance, helping you stay ahead of regulatory changes and emerging performance data. Our commitment to continuous evaluation ensures that your device remains compliant and performs as expected throughout its lifecycle.

Practical Considerations

Gap Analysis: We start with a gap analysis to identify any deficiencies in the current state of knowledge and performance data for your device. This analysis addresses:  

  • Technology comparison with the current state of the art  
  • Existing research on the device and its intended purpose  
  • Proof of concept studies and their robustness  
  • Analytical performance testing and standards used  assurance levels of test results      

 

Resource Planning: We also conduct a financial feasibility analysis to ensure that adequate resources are available for the performance evaluation process, including any additional testing and clinical data gathering required.  

Why Choose LFH Regulatory?

  • Exceptional Customer Support: Our team is dedicated to providing responsive and personalised support. We pride ourselves on our ability to react swiftly to the changing needs of our clients and the IVD industry, ensuring a seamless experience from start to finish.  
  • Adaptable to Industry Changes: We stay agile and adapt to the latest regulatory changes and industry trends. Our proactive approach keeps your performance evaluation process ahead of the curve and ensures compliance with the latest standards.  
  • Proven Track Record: Our extensive experience and success stories demonstrate our capabilities. We have helped numerous clients navigate the complex regulatory landscape, bringing their devices to market efficiently and effectively. Our proven track record of successful evaluations and satisfied clients is a testament to our expertise and commitment to excellence.  

 

Get in touch today.  

Ready to streamline your performance evaluation process and bring your IVD to market faster?

Our team is here to help. Fill out the contact form below to get started, and let us guide you through the complexities of performance evaluation with confidence.  

Explore Our Supporting Services

In addition to our core consultancy services, LFH Regulatory offers an array of supporting services to meet the diverse needs of our clients. Our comprehensive suite of services includes: 

Medical Device Software
We specialise in navigating the unique challenges of medical device software, ensuring compliance and safety in this increasingly vital field. From data security to user interface design, we are your partners in ensuring that software-driven devices meet regulatory standards.
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UK Responsible Person
For manufacturers located outside the UK, we serve as your trusted UK Responsible Person, facilitating compliance with UK regulations. Our expertise in UK MDR 2002 ensures that your devices can access the UK market efficiently and effectively.
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Global Registrations
We streamline the complex process of global registrations, ensuring your products can reach international markets. From the EU to the USA and beyond, we manage the intricacies of diverse regulatory requirements.
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Training
Empower your team with regulatory expertise through our comprehensive training programs. Our training covers all aspects of medical device regulations, ensuring your team is well-equipped to navigate the ever-changing regulatory landscape.
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Unlock the Power of Medical Device Consultancy

At LFH Regulatory Ltd, our medical device consultants bring extensive experience and regulatory knowledge to the table. We collaborate with a diverse array of clients, establishing connections with global regulatory bodies for efficient regulatory approvals. Contact us today and explore how our consultancy can help you successfully navigate the intricate world of medical device regulations.