Our Performance Evaluation Plan and Report services support IVD manufacturers in demonstrating scientific validity, analytical performance, and clinical performance under the EU IVDR 2017/746. Patient Guard helps you prepare compliant, structured, and audit-ready performance evaluation documentation for CE marking and EU market access.
IVD manufacturers placing devices on the European market must prepare and maintain performance evaluation documentation to demonstrate compliance with the EU In Vitro Diagnostic Regulation (EU) 2017/746.
A Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) are key documents required under IVDR. They demonstrate that an IVD device achieves its intended purpose and has sufficient clinical evidence to support safety, performance, and benefit-risk conclusions.
Patient Guard provides expert Performance Evaluation Plan and Report services for IVD manufacturers, supporting the preparation, review, remediation, and ongoing maintenance of IVDR-compliant performance evaluation documentation.
We help manufacturers build structured, evidence-based performance evaluation files aligned with IVDR requirements and notified body expectations.
Whether you are preparing a new performance evaluation, updating legacy IVDD documentation, or responding to notified body feedback, we provide a clear and compliant pathway to IVDR readiness.
This page explains Patient Guard’s Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) services for IVD manufacturers seeking CE marking under Regulation (EU) 2017/746. If you're looking for a broader introduction to the IVDR, including device classification, Performance Evaluation, Scientific Validity, Analytical Performance, Clinical Performance, Risk Management, Technical Documentation and Post-Market Performance Follow-up (PMPF), read our IVDR for Beginners – A Comprehensive Guide.
We develop and structure a compliant Performance Evaluation Plan (PEP) establishing the strategy, testing methodologies, and clinical data paths needed to prove diagnostic intent.
We critically review and document scientific evidence establishing the biological or clinical relationship between your target analyte and the specific clinical condition.
Our specialists systematically evaluate and compile critical laboratory performance traits (accuracy, sensitivity, specificity) alongside true diagnostic output metrics.
We assemble the final Performance Evaluation Report (PER) that synthesizes your testing endpoints and validation studies into an integrated document optimized for Notified Body submission.
We review your legacy IVDD documentation or incomplete evaluation data sets, perform comprehensive gap analyses, and align your file cleanly with Post-Market Performance Follow-up rules.
We assess your current IVD product classification parameters, intended diagnostic profile, and target timelines.
We appraise historical data files, literature findings, and lab studies to map out required regulatory remediation pathways.
We build out your comprehensive Performance Evaluation Plan, outlining clear data validation mechanisms.
We finalize the integrated Performance Evaluation Report to ensure audit alignment and seamless conformity assessment.
Under Regulation (EU) 2017/746, IVD manufacturers must demonstrate that their devices achieve their intended purpose and meet applicable performance and safety requirements.
A compliant performance evaluation typically includes:
Performance evaluation must be based on sufficient clinical evidence and maintained throughout the device lifecycle.
We assess your IVD device, intended purpose, classification, and current documentation status.
We review existing performance data, literature, study reports, risk management files, and technical documentation.
We define the performance evaluation strategy, evidence requirements, and evaluation methodology.
We prepare or update the report, documenting scientific validity, analytical performance, clinical performance, and conclusions.
We support final checks, Technical File integration, and responses to auditor or notified body feedback.
We support performance evaluation documentation for a wide range of IVDs, including:
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Ensure regulatory compliance and market readiness with expertly prepared Performance Evaluation Plans and Reports. Pricing starts from £9,000, with preferential rates for multiple products.
Review of intended purpose, classification, and existing scientific, analytical, and clinical data against IVDR requirements.
Preparation of Performance Evaluation Plan and Report, including scientific validity, analytical performance, and clinical performance sections.
Final documentation checks and support for Technical File integration and Notified Body review.
A Performance Evaluation Plan defines the strategy and methodology for demonstrating an IVD device’s scientific validity, analytical performance, and clinical performance under IVDR.
A Performance Evaluation Report documents the results and conclusions of the performance evaluation and demonstrates that the IVD device achieves its intended purpose.
Yes, all IVDs placed on the EU market under IVDR require performance evaluation documentation. The depth and complexity depend on device classification, intended purpose, and available evidence.
Evidence may include scientific literature, analytical performance studies, clinical performance studies, state-of-the-art data, risk management documentation, and post-market evidence.
Yes, we can review, update, and remediate existing Performance Evaluation Reports to align with IVDR and notified body expectations.
Click on the links below to discover more:
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Preparing to sell digital health technology to the NHS requires more than completing DTAC. This guide explains how manufacturers can build a procurement-ready position by aligning regulatory compliance, clinical safety, data protection, cybersecurity, interoperability, accessibility and commercial evidence for NHS market access.
For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.
If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
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