IVDR Performance Evaluation Plan and Report Writing (PEP and PER) for In Vitro Diagnostic Devices

Whether your In Vitro Diagnostic device has been on the EU market for decades or you’re pursuing CE marking under the EU IVDR for the first time, NAMSA’s regulatory and medical writing teams are ready to help you gather, assess, and evaluate all necessary clinical evidence to support your submission or maintain post-market compliance. Performance evaluation is not just a regulatory requirement—it’s a strategic imperative for demonstrating your device’s safety, performance, and clinical benefit.

Quick facts about IVD performance evaluation: 

• Performance evaluation is mandated in Annex XIII of the EU IVD Regulation (2017/746)
• Required for all Class B, C, and D IVDs under IVDR
• Must demonstrate scientific validity, analytical performance, and clinical performance
• Must be updated throughout the device lifecycle as new data becomes available
• Serve as the cornerstone for demonstrating benefit-risk conformity and clinical evidence sufficiency
• A well-constructed PEP and PER can significantly streamline CE marking and reduce Notified Body queries

Performance Evaluation Plan (PEP): Building a Strategic Foundation

The Performance Evaluation Plan (PEP) is the blueprint for generating and assessing the clinical evidence required under the EU IVDR. It defines the performance evaluation’s scope, methodology, and objectives and ensures alignment with Annex XIII and the General Safety and Performance Requirements (GSPRs). A well-developed PEP is essential for setting a clear evidentiary path and avoiding downstream regulatory challenges. Our PEP development process includes:

• Device characterization: Defining the intended purpose, indications, and risk classification
• State-of-the-art analysis: Establishing the scientific and clinical context for the device
• Performance claim mapping: Identifying analytical and clinical performance endpoints
• Evidence strategy: Outlining data sources, including literature, clinical studies, and post-market data
• Methodological justification: Detailing the rationale for chosen evaluation methods and metrics
• Lifecycle planning: Incorporating provisions for updates and Post-Market Performance Follow-Up (PMPF)

By investing in a robust Performance Evaluation Plan, manufacturers can proactively address regulatory expectations, reduce Notified Body queries, and streamline the development of the Performance Evaluation Report. At NAMSA, we develop PEPs that are tailored, methodologically sound, and regulator-ready. Our approach is collaborative and strategic, ensuring that the plan reflects the unique characteristics and risk profile of your IVD device.

Performance Evaluation Report (PER): Demonstrating Performance Evidence and Regulatory Readiness

The Performance Evaluation Report (PER) is the definitive output of the performance evaluation process. It consolidates and critically appraises all available evidence to demonstrate that the IVD device performs as intended and meets the safety and performance requirements of the IVDR. The PER must be scientifically rigorous, transparent, and aligned with the methodologies outlined in the PEP.

At NAMSA, we understand that the Performance Evaluation Report must do more than summarize data—it must present a scientifically rigorous, transparent, and regulator-ready narrative that aligns with the methodologies outlined in the Performance Evaluation Plan (PEP). Our medical writers apply deep regulatory insight and scientific discipline to ensure each PER is tailored to the device’s risk class, intended purpose, and evidentiary complexity. Key elements of our PER development include:

• Evidence synthesis: Integrating data from literature, clinical studies, and post-market sources
• Critical appraisal: Evaluating each data source’s quality, relevance, and limitations
• Performance demonstration: Clearly linking evidence to analytical and clinical performance claims
• Regulatory alignment: Ensuring conformity with Annex XIII and applicable MDCG guidance
• Gap identification: Highlighting areas where additional data or justification may be needed
• Audit readiness: Structuring the report for clarity, traceability, and regulatory defensibility

With NAMSA, your PER becomes more than a compliance document—it becomes a strategic asset that supports CE marking, facilitates regulatory dialogue, and reinforces your commitment to clinical excellence.

NAMSA: A Strategic Partner for IVDR Performance Evaluation

NAMSA stands apart as a strategic partner for IVD manufacturers navigating the complexities of EU IVDR compliance. Our strength lies not only in our technical proficiency but in our deep-rooted specialization in in vitro diagnostics. With a team of seasoned medical writers and regulatory experts who have worked extensively across a broad spectrum of IVD technologies, we bring both precision and perspective to every engagement. This depth of experience allows us to anticipate regulatory expectations and tailor our approach to each device’s unique risk profile and intended purpose.

We also recognize that performance evaluation is not a standalone activity—it’s part of a broader regulatory and clinical strategy. That’s why our services extend beyond medical writing. We work closely with our regulatory colleagues to support gap analyses, define evidence generation strategies, and ensure alignment with the General Safety and Performance Requirements (GSPRs). Whether reparing for initial CE marking or responding to Notified Body feedback, NAMSA delivers the insight and agility needed to move forward with confidence.

Specialized IVD Expertise Across Modalities

Our medical writing and regulatory teams bring extensive experience across a broad spectrum of IVD technologies:

• Complex platforms: Hematology analyzers, mass spectrometry, histopathology systems
• Molecular diagnostics: Genetic testing, oncology biomarkers, infectious disease panels
• Software-driven IVDs: Standalone and embedded algorithms, AI/ML-based diagnostics
• Therapeutic Drug Monitoring (TDM): Navigating nuanced clinical performance requirements

We understand the unique evidentiary challenges posed by each modality and tailor our approach accordingly.