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IVD Performance Evaluation – Statement of Work

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The IVD Performance Evaluation Statement of Work outlines the responsibilities of both the consultant and the manufacturer regarding the preparation of the Performance Evaluation Report, which is a crucial component of the IVDR CE Marking technical documentation and compliance process. This SOW covers the PER only; for the full project scope, from device classification to the notified body certificate, see our IVDR certification statement of work. Here’s a breakdown of the typical responsibilities outlined in such a document:

IVDR performance evaluation report statement of work

 

#REQUIREMENTSCOPE OF I3CGLOBALSCOPE OF MANUFACTURER
I.The introduction of EU IVDR 2017/746 aims to enhance the safety and performance requirements for in vitro diagnostic devices (IVDs) while ensuring a robust regulatory framework that keeps pace with technological advancements and scientific understanding.Assist companies in understanding the requirements set forth by the EU IVDR 2017/746 and ensure that their products meet the necessary safety and performance standards. This may involve reviewing and interpreting the regulation, identifying gaps in compliance, and developing strategies to address them.Inform the I3CGLOBAL team of all the information related to the device and its components with at most accuracy.
I(a)The performance and safety need to be proved with proper clinical evidence (scientific validity + analytical performance + clinical performance). This applies to legacy devices which are already on the market as well as new devices which are to be introduced into the market 

An assessment of each device’s performance will be documented based on the regulatory requirements listed in Annex XIII Part A (Performance Evaluation and Performance Studies), Article 56 (Performance Evaluation And Clinical Evidence ).

Based on the device type need to Provide

  • The technical file of the device,
  • Performance study reports where applicable (analytical performance report, clinical Performance Report)
  • pre-clinical or bench test reports,
  • RMF,
  • Usability study report,
  • Legacy devices (IVDD approved) information regarding PMS data, PSUR/PMSR,

·       PMPF study report,

·       User guide/IFU.

STEP 1 – PLANNING
1Performance EvaluatorGuidance and drafting of templates for the declaration of Interest.Identify and appoint a Performance Evaluator
1.1Develop Performance Evaluation Procedure in line with standard requirements.

  • Performance Evaluation Plan
  • Scientific Validity Plan
  • Literature Search Plan including SOTA
  • Appraisal Plan
  • Develop procedure and or modify customer-supplied procedure(s) if required
  • Develop the necessary record templates in line with procedure and develop strategies for performance evaluation, literature search and appraisal.
  • Clarify doubts, when necessary.
  • Assign responsibilities.

·        Review and approval.

STEP 2 – DATA ESTABLISHMENT
2.1Clinical Evidence Retrieved from the Manufacturer

(Analytical performance studies + Clinical performance studies)

  • Guides manufacturers on pre-clinical and non-clinical studies.
  • Identifies clinical evidence that can be retrieved from the manufacturer and adds data based on that to the template.
Extend necessary support for consultants with necessary data such as

  • Analytical performance studies (analytical performance characteristics like analytical sensitivity, analytical specificity, accuracy and precision, measuring range etc.)
  • Provide information on any clinical studies such as Clinical performance studies as per ISO 20916 (clinical performance characteristics diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected value in normal and affected populations etc.)
  • Post-market studies on the device
2.2a) Scientific Validity Report

 

b) Literature Search and Review Report

  • Develop detailed SOP.
  • Develop a relevant Scientific validity report template.
  • Develop relevant Literature search and review report template.
  • Perform a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, GSPR [EU IVDR] and SOTA/SOA, and prepare the literature search report for meeting the requirement of safety and performance of the device.
  • Prepares literature search review report based on the review questions added to the Literature search plan.
  • Prepare a scientific validity report based on the sources added in the Scientific validity plan.
 

·        Review and approve.

STEP 3 – APPRAISAL, ANALYSIS AND DOCUMENTING CONCLUSIONS
3.1Demonstration of Equivalence (if applicable)
  • Develop detailed SOP.
  • Develop a Demonstration of Equivalence in PER based on MDCG guidance.
  • Performs Demonstration of equivalence, if applicable
  • Inform about similar device details obtained from pieces of literature (if any)
·        Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency)

·        Must have sufficient access to equivalent device data on an ongoing basis (if applicable)

3.2Appraisal and Analysis of the Clinical Evidence
  • Develop detailed SOP.
  • Develop appraisal and analysis of clinical evidence template
  • Appraises and performs qualitative analysis of the clinical data obtained from the literature as well as clinical evidence retrieved from the manufacturer based on corresponding GSPRs and also on the criteria set in the Appraisal plan.
 

·        Review and approve.

STEP 4 – DEVELOPMENT OF PER
4.1(a)Data related to use-related hazards that have an impact on the Performance evaluation need to be considered by Risk Management

And IFU/User guide/User Manual

  • Risks identified from similar devices’ performance evaluation will be forwarded to the risk management team to update the RMF accordingly. After risk management activities, the final results on risks/residual risks will be concluded in PER.
  • Also, for Benefit-Risk quantification and Conclusion review and suggestion.
  • Suggests changes in the IFU/User guide based on the inputs from the PER, RMF, PMS, PSUR and PMPF.
  • Share the existing Risk procedure and RMF.
  • Modify RMF/IFU based on the outputs of PER.

·        Review and approve.

 

4.1(b)Post-Market Surveillance and Vigilance Reporting
  • Develop or modify the PMS procedure.
  • Develop templates such as PMS plan, Sales Data, Customer Feedback, User Feedback and Review of PMS Plan, as needed.
  • Support in the PMS planning.
  • Review the collected data based on the PMS sources.
  • Preparation of PMS report for Class A and Class B devices will be updated when necessary and made available to the competent authority upon request
  • Drafts or guides in the preparation of Vigilance procedure and associated templates
  • Extend necessary support by following the PMS plan scheduled for the PMS period.
  • Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback
  • Review and approval of the PMS plan, and the evidence
  • Review and approval of PMSR and reports associated with Vigilance.
4.1(c)Post Market Performance Follow-up

 

  • Prepares procedure for PMPF, if required.
  • Prepares PMPF Plan & Evaluation Report templates based on the MDCG guidance.
  • Supports in the selection of devices for PMF.
  • Prepares PMPF plan.
  • Guides to choose the suitable PMPF methods (general and specific) as per the characteristics and type of medical devices.
  • Verifies the findings and the results based on the PMPF methods chosen Compiles the PMPF evaluation report.
  • Extend necessary support by following the PMPF plan by following the PMPF period selected in line with the PMS.
  • Identify methods of PMPF-based consultant’s inputs.
  • Perform general and specific PMPF activities such as Surveys and Clinical Performance studies (If applicable)- to be outsourced to a third-party agency.
  • Review and approve PMPF plan, other evidence and PMPF Evaluation Report
4.1(d)Periodic Safety Update Report

 

(Not applicable for Class A and Class B devices)

  • Develop PSUR template based on MDCG guidance, as needed.
  • Review the collected data and evidence based on the PMS sources.

·        Preparation of PSUR for risk Class C and Class D devices and will be updated at least annually.

  • Extend necessary support by following the PMS plan scheduled for the PMS period.
  • Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback or any other relevant information requested.
  • Review and approve the summarized evidence of PMS data in the PSUR.
4.1Performance Evaluation Report
  • Develop detailed SOP.
  • Develop PER template. (includes Scientific validity report, analytical study report, and clinical performance report)
  • Add information on the PER template based on the summary of inputs from the clinical evidence provided by the manufacturer and/or the literature or from the Clinical performance study report from step 1 to step 3 meeting the GSPRs.
  • Review and approve PER by the assigned performance Evaluator(s).
How we help

IVDR Performance Evaluation Support from I3CGLOBAL

Our IVDR consultants prepare and maintain performance evaluation documentation for IVD manufacturers worldwide, across all risk classes from Class A to Class D.

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FAQ

IVDR PER SOW: Frequently Asked Questions

What is a PER Statement of Work?

It is a document that sets out which tasks I3CGLOBAL performs and which tasks the manufacturer performs to prepare the Performance Evaluation Report (PER) under EU IVDR 2017/746. It covers planning, data collection, appraisal, analysis and the final report.

How long does it take to prepare a Performance Evaluation Report?

With good cooperation from the manufacturer, it usually takes 3–4 months for Class A and B devices and 5–6 months for Class C and D devices.

Do you provide performance evaluators?

Yes. We help you identify and appoint a qualified performance evaluator and prepare the declaration of interest templates. The assigned evaluator reviews and approves the final PER.

What documents does the manufacturer need to provide?

Typically the technical file, analytical and clinical performance study reports, bench test reports, the risk management file, the usability report and the IFU. For legacy IVDD devices, PMS data, PSUR or PMSR and PMPF reports are also needed.

Is a PER required for legacy IVDD devices?

Yes. Devices already on the market under the IVDD must show clinical evidence under the IVDR, based on scientific validity, analytical performance and clinical performance, as required by Article 56 and Annex XIII Part A.

How often must the PER be updated?

The PER is updated throughout the device lifecycle using post-market surveillance and PMPF data. For Class C and D devices, it must be updated at least once a year.

Is a PSUR needed for every device class?

No. Class C and D devices need a Periodic Safety Update Report, updated at least annually. Class A and B devices need a Post-Market Surveillance Report, updated when necessary and made available to the competent authority on request.

Who approves the documents in the statement of work?

I3CGLOBAL drafts the procedures, plans, templates and reports. The manufacturer reviews and approves each deliverable, and the assigned performance evaluator approves the final PER.


Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Swathi Tummala, Senior Regulatory Consultant, I3CGLOBAL