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.
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:
From
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:
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.
A milestone that strengthens our commitment to quality
Regulatory and quality consulting is one thing. Building, implementing, and passing audits on your own Quality Management System is another.
UDI medical devices are not just a labelling requirement. They are the backbone of traceability under EU MDR.
EUDAMED enters a new phase as four modules become mandatory from 28 May 2026. Learn what changes and how to prepare for compliance.
Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
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.
UK Office
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.
UK Office
Thank you! The checklist is now ready to download.
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.
UK Office
