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 develops technical documentation files that tell a unified clinical evidence with help of strong PER.
The I3CGLOBAL team develops the PEP, conducting literature searches, and compiling 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.
IVDR Performance Evaluation Report Criteria
An important part of the technical documentation is the Performance Evaluation Report (PER), 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 IVDR Performance Evaluation must be carefully planned in line with Annex XIII Part A. As part of this planning process, a comprehensive Performance Evaluation Plan (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 Performance Evaluation Plan 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 Performance Evaluation Plans 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.