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.
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.
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Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.
Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.
If you are implementing a medical device QMS, preparing for certification, or recovering from audit findings, understanding ISO 13485:2016 requirements is non-negotiable.
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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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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