The evolving regulatory landscape for in Vitro Diagnostic Medical Devices (IVD)under the revised EU Regulation 2017/746 places significant emphasis on performance evaluation to demonstrate device safety and effectiveness. Article56 of the In-Vitro Diagnostics Regulation (IVDR) outlines specific guidelines for manufacturers to prepare and submit a Performance Evaluation Report (PER) that aligns with intended use and regulatory requirements.

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Understanding the Requirements

Article56 of the IVDR focuses on General Safety and Performance Requirements (GSPR)detailed in Annex I, emphasising the importance of scientific validity, analytical performance, and clinical evidence. Compliance with ISO 20916:2019and Annex XIII is essential, requiring manufacturers to establish a robustPerformance Evaluation Plan (PEP) covering the device lifecycle beyond development stages.

Key Steps for a Successful Performance Evaluation Strategy

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Step 1: Grasping Article 56

Familiarise yourself with GSPR and Annex I requirements, including the benefit-risk assessment based on scientific, analytical, and clinical performance. Develop a Standard Operating Procedure (SOP) for performance evaluations to ensure compliance throughout the device lifecycle.

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Step 2: Developing a Performance Evaluation Plan (PEP)

Craft a device-specific PEP that outlines the state-of-the-art knowledge and intended use of the device. Reference relevant standards, guidelines, and best practices while detailing analytical and clinical performance methods and risk considerations.

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Step 3: Scientific Validity Assessment

Conduct a comprehensive literature search to establish the scientific validity of the analytes or biomarkers used in the IVD. Document search strategies, datasources, and evidence from professional societies or expert opinions. Generate additional data through proof-of-concept or clinical studies to address gaps in scientific validity.

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Step 4: Analytical Performance Evaluation

Define specific parameters for analytical performance, including specificity, sensitivity, and reproducibility. Conduct bench studies and verification tests to assess subsystems and sample handling processes. Summarise results in an Analytical Performance Report for inclusion in the PER.

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Step 5: Clinical Performance Evaluation

Prepare a protocol for clinical performance studies aligned with ISO 20916:2019 andAnnex XIII requirements. Gather data to demonstrate correlation with clinical conditions or outcomes, leveraging established tests and literature sources.Compile findings into a Clinical Performance Report to support device effectiveness.

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Step 6: Demonstrate IVD Stability:

Demonstrate device stability based on IVDR Annex II requirements, considering shelf life and in-use conditions. Follow guidelines from the Clinical and LaboratoryStandards Institute (CLSI) for stability testing, ensuring compliance with regulatory standards.

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Step 7: Performance Evaluation Report (PER)

Synthesise validated results from scientific, analytical, and clinical evaluations into a comprehensive PER. Evaluate clinical evidence against medical advancements and device technology, demonstrating a positive benefit-risk profile.

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Step 8: Post-Market Performance Follow-up (PMPF) Plan

Implement a PMPF plan to monitor device safety and performance throughout its lifecycle. Collect and analyse clinical data to identify emerging risks and ensure on going compliance with regulatory standards.

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Looking Ahead:

Navigating the performance evaluation pathway outlined in the EU IVDR requires a meticulous approach to compliance and evidence generation. Manufacturers must prioritise scientific validity, analytical precision, and clinical relevance to achieve successful market entry in the European Union.

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Seek Expert Guidance:

For personalised support in navigating EU IVDR performance evaluation requirements, consult with our team of regulatory specialists. We provide tailored solutions to ensure your IVDs meet regulatory standards and deliver safe, effective results in the market.

Ready to elevate your regulatory strategy?

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Contact us: https://www.peplobio.com/support