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IVDR Performance Evaluation Report
One of the most important aspects of attaining IVDR certification is demonstrating appropriate clinical evidence via IVDR performance evaluation report which extends beyond your risk management, PMS, PMPF, and labelling. The IVDR consultants develop technical documentation files that tell a unified clinical evidence with the help of strong PER.
The I3CGLOBAL team develops the PEP, conducts literature searches, and compiles the PER, which contains the state-of-the-art analysis, scientific validity report, analytical performance report, and clinical performance report. In order to ensure notified body approval we strictly follow various checks by separate personnel at the end prior to submission.
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IVDR Performance Evaluation Report Criteria
An important part of the technical documentation is the IVDR Performance Evaluation Report, which must be carefully aligned with the IVDR GSPR listed in Annex I of IVDR 2017/746. This alignment calls for a thorough evaluation of various factors, such as the device’s normal conditions, intended use, potential interferences, cross-reactions, and the acceptability of the benefit-risk ratio overall.
In order to comply with regulatory requirements, the Performance Evaluation must be carefully planned in line with Annex XIII Part A. As part of this planning process, a comprehensive PEP must be created where evidence is methodically recorded.
In order to ensure that the technical documentation is in compliance with IVDR 2017/746 requirements and reflects a comprehensive and compliant approach to performance evaluation, it is essential that the manufacturer’s Quality Management System (QMS) explicitly incorporate provisions for IVDR performance evaluation.
The best way to accomplish this integration is to put in place a strong procedure that integrates the PER into the technical documentation in a seamless manner. This procedure serves as a means of summarizing and presenting the data collected.
All type of IVD devices, class A, B, C or D needs to have a PEP and Report in place. Depending on the type, risk, and novelty of the device, these documents can vary greatly in complexity. For higher risk IVDs, more pertinent data should be collected and analyzed, ideally through performance evaluations.
Good understanding of Article 56, Annex XIII, as well as relevant MEDDEV and MDCG guidance documents will be paramount in meeting the requirements of the Performance Evaluation and thus getting your product to market.
Using our team of in-house and experienced IVDR consultants, along with our CRO division completes PEP and Reports for all types of devices. The documents we create for are state-of-the-art and are updated regularly to reflect changes in interpretation, best-practice, and expectations of Notified Bodies.
Support from experienced IVDR Consultants is essential, even if the employees are experienced with IVDD
Key Roles of CROs in Performance Evaluation under IVDR
Clinical Research Organizations work closely with manufacturers and consultants to design performance evaluation studies that meet IVDR requirements. They ensure that studies are appropriately structured to collect the necessary data, covering aspects like analytical performance, clinical performance, and scientific validity. CROs start with drafting the IVDR Performance Evaluation Plan, which outlines the study’s objectives, endpoints, methodology, and data analysis approach, ensuring the design meets regulatory expectations and intended benefits and claims as per the manufacturer user manual / IFU. The following are the core activities carried by CROs:
- CROs manage the entire study process, including site selection, participant recruitment, sample management, and oversight of data collection to maintain the study’s integrity and ensure compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards.
- They coordinate logistics, manage resources, and monitor data collection processes to ensure consistency, accuracy, and adherence to the study protocol.
- Contract Research Organizations streamline the process of data collection, guaranteeing its accuracy, completeness, and traceability. They compile data on precision, sensitivity, specificity, and robustness to assess analytical performance. For clinical performance, they amass evidence of the efficacy of the device within the target population.
Our Consultants assist in the selection of a CRO that best suits the IVD device-specific features and manufacture indications and needs, considering factors such as the CRO’s expertise in IVDs, experience with IVDR compliance, and capacity for specific testing requirements. We often oversee contract negotiations and ensure that both parties agree on expectations for communication, reporting, deliverables, and quality standards in line with Notified Body and IVDR 2017/746 requirements.
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Frequently Asked Questions
Is performance Evaluation being a continues process?
Yes, the process of performance evaluation is designed to be continuous, involving the gathering of clinical evidence throughout the lifespan of the product. This is achieved with the assistance of the post-market performance follow-up process
Very useful for small and medium size medical device manufactures
