PER - STATEMENT OF WORK
The PER (Performance Evaluation Report) Statement of Work (SOW) 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. Here’s a breakdown of the typical responsibilities outlined in such a document:
| # | REQUIREMENT | SCOPE OF I3CGLOBAL | SCOPE 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
· 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 | |||
| 1 | Performance Evaluator | Guidance and drafting of templates for the declaration of Interest. | Identify and appoint a Performance Evaluator |
| 1.1 | Develop Performance Evaluation Procedure in line with standard requirements.
· Performance Evaluation Plan · Literature Search Plan · 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 | |||
| 2.1 | Clinical 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 of 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 effected populations etc.) · Post-market studies on the device |
| 2.2 | Literature Search and Review Report | · Develop detailed SOP.
· 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. |
· Review and approve. |
| STEP 3 – APPRAISAL, ANALYSIS AND DOCUMENTING CONCLUSIONS | |||
| 3.1 | Demonstration 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) |
| 3.2 | Appraisal 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, 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 and 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 selection of devices for PMPF. · 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. |
| 4.1 | Performance Evaluation Report | · Develop detailed SOP.
· Develop PER template. · Adds 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). |