Clinical and Post-Market

Performance Evaluation Report (PER)

Your PER is the key document for performance evaluation, bringing all elements of clinical evidence together for the device in context with benefit-risk statements and state-of-the-art status. 

It provides you with an opportunity to discuss your IVD device in terms of its intended purpose and risk classification. Therefore, manufacturers should compile evidence, determine the benefit-risk and document the performance evaluation and its output as part of this report. 

However, many IVD manufacturers face challenges in producing the clinical data necessary under the IVDR due to significantly more stringent requirements. 

That’s why at Apotech, we can offer end-to-end support in the following areas:

• Clinical evidence justification
• Literature search methodology, protocol and report
• Device description, intended use, performance and safety claims
• Scientific validity, analytical performance and clinical performance
• Clinical evidence and state-of-the-art comparison
• PMPF evaluation report updates

Post-Market Surveillance (PMS) and Post-Market Performance Follow up (PMPF) 

The IVDR sets out that ‘the clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device.’ So, to fulfil post-market requirements, you’ll need to conduct a Post-market Performance Follow-up (PMPF). 

The PMPF is meant to be a continuous collection of clinical data on the performance of your device after it has been placed on the market. 

Post-market information, such as data from the manufacturer’s post-market surveillance system should be reviewed regularly and used to determine the potential impact on the risks, clinical benefit and whether there is a need to update the performance evaluation report of the IVD. 

As a manufacturer, you must ensure that all appropriate methods, procedures and product-specific triggers to proactively collect and evaluate safety, performance and scientific data are included as part of your PMPF plan.

Our team can support you with:

• Developing comprehensive PMPF strategies and plans
• Identifying relevant data sources, establishing data collection protocols and implementing systems for timely data analysis and reporting
• Updating PEP or PER as part of the PMPF
• Updating IVD clinical evidence, as appropriate
• Post-market performance studies
• Establishing procedures for signal detection, investigation and risk management, including the implementation of corrective and preventive actions (CAPAs) as necessary

FDA

Manufacturers in the USA are expected to compile and maintain documentation that demonstrates the analytical and clinical performance of their IVD devices. From analytical validation studies to regulatory submissions and post-market surveillance, navigating the clinical aspects of IVD development requires meticulous planning, execution and adherence to regulatory requirements. 

Our team can support you in the following clinical areas.

• Analytical and clinical performance evaluation: The FDA expects manufacturers to demonstrate both the analytical and clinical performance of their IVD devices. This involves conducting studies to assess the accuracy, precision, sensitivity, specificity and various other performance-related characteristics of the device.
• Analytical validation studies: Manufacturers must conduct analytical validation studies to evaluate your device's performance under controlled laboratory conditions. These studies assess its ability to accurately and reliably measure analytes of interest.
• Clinical validation studies: Clinical validation studies are conducted to evaluate the device's performance in real-world clinical settings. These studies compare the device's results to those of a reference method or gold standard and assess its diagnostic accuracy, sensitivity, specificity and various other clinical performance characteristics.
• Post-market surveillance (PMS): Manufacturers must implement post-market surveillance programmes to monitor the performance of their IVD devices after they are placed on the market. This includes not only collecting and analysing data on device failures, adverse events and several other safety or performance issues but also taking appropriate corrective and preventive actions when required.

Clinical trial consulting

Conducted by a team of experts with more than two decades of experience in clinical trials and compliance, we can provide tailored IVD clinical study design and protocol development services that carefully balance the needs of your stakeholders. 

Designed to assess the analytical and clinical performance of IVD technologies, clinical trials provide critical evidence to support the diagnostic accuracy, reliability and relevance of your IVD devices in real-world healthcare settings. 

Our clinical trial research consultants can provide expert guidance on essential elements of study design, considering the necessity, implications and practicality of each decision. 

We can also support you with:  

• Study design
• Health economics and reimbursement planning
• Literature review
• Protocol writing and review
• Resource planning
• Statistical analysis plans for clinical trial protocols
• Clinical investigation plan
• Investigators brochure