The EU IVDR 2017/746 defines Performance Evaluation for In Vitro Diagnostic Medical Devices (IVD) in article 2 as:
“an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.”
Performance Evaluation for In Vitro Diagnostic Medical Devices Overview
The Performance Evaluation for In Vitro Diagnostic medical devices serves as a fundamental framework for performance evaluation. However, crafting the PEP can be quite intricate and demanding due to its critical role in demonstrating the device's safety, efficacy, and alignment with its intended use. To ensure the development of a well-established and high-quality document, it is essential to adhere to the detailed requirements laid out in Annex VIII of the EU IVDR 2017/746.
Designing your IVDR Performance Evaluation Plan (PEP) Template
To create an effective IVDR performance evaluation plan (PEP) template following points should be considered:
- Define Intended Use and Performance Characteristics The initial step involves meticulous determination and definition of the device's intended use. This should encompass specific disorders, conditions, or risk factors that the IVD device is designed to detect.
- Identify Performance Characteristics Once the intended use is established, the subsequent task is to identify the performance characteristics of the device. The PEP must include the basis of specifications used to assess the device's performance, covering parameters such as sensitivity, specificity, accuracy, trueness, repeatability, reproducibility, limits of detection, and quantitation for both analytical and clinical performance.
- Determine Clinical Evidence Requirements Based on the intended use and performance characteristics, an evaluation of the device's clinical evidence requirements must be conducted. This entails determining the type of clinical studies needed to effectively demonstrate the device's safety and performance.
- Outline Development Phases The PEP should provide a comprehensive overview of each development phase, including the sequence and methods used to assess scientific, analytical, and clinical performance. It is imperative to include a synopsis of key stages in the process and the potential acceptance criteria.
- Performance Evaluation Plan Updates As the study progresses and new information emerges, it may be necessary to update the PEP. This could involve revising study protocols, adjusting clinical evidence requirements, or modifying the Performance Evaluation Plan in its entirety to accommodate changes in the intended use or performance characteristics of the device.
By meticulously adhering to these steps and incorporating any updates based on study results, manufacturers can ensure a well-structured and effective performance evaluation plan, ultimately facilitating a robust performance evaluation of their IVD devices as mandated by the EU IVDR.
Freyr, a renowned provider of regulatory solutions, offers comprehensive support in Performance Evaluation Plan (PEP) services for medical writing. With the expertise in the EU IVDR 2017/746 and vast knowledge of regulatory requirements, Freyr assists in devising well-structured PEPs. From defining intended use to determining performance characteristics and clinical evidence requirements, Freyr ensures high-quality documentation to meet regulatory compliance.
- Transition plan for IVDR compliance.
- Scientific validity reports based on literature and/or in-house data.
- Clinical performance reports based on literature and/or in-house data.
- Analytical Performance Reports.
- Clinical Evidence or Performance Evaluation Reports as per IVDR
- Performance Evaluation Plan (PEP) Template
- Post Market Performance Follow Up (PMPF) protocols and reports.
- Post Market Surveillance (PMSR) protocols and reports.
- Writing/Revising other documents, such as package insert/IFU, Quick Reference Instructions (QRI), operation/user manual, etc.
- Assured compliance with recent applicable regulations.
- Team of qualified experts.
- Tailored Solutions to your requirements
- Regulatory Resource Management/Staff Augmentation Services
- Cross-functional inputs from Medical Device experts to comply with requirements.