For In Vitro Diagnostic Medical Devices (IVDs), performance evaluation is a crucial prerequisite that guarantees the device continuously produces precise, dependable, and clinically meaningful results throughout its intended use. Manufacturers must create and maintain thorough performance assessment documentation to prove the efficacy and safety of their IVD products.
Comprehensive performance evaluation support to demonstrate the clinical performance, analytical performance, and scientific validity of IVD devices.
The Performance Evaluation Plan (PEP) establishes the methodology and process for assessing the clinical performance, analytical performance, and scientific validity of an IVD device. It describes the objectives, data sources, evaluation criteria, and methods for collecting and analysing performance data.
By gathering and evaluating all pertinent performance data, the Performance Evaluation Report (PER) shows the results of the evaluation process. It demonstrates that the device consistently performs its intended purpose and meets the relevant performance and regulatory standards.
In compliance with regulatory standards, we develop organised Performance Evaluation Plans and detailed Performance Evaluation Reports to aid in technical documentation, market authorisation, and conformity assessment.
Clinical Performance Evaluation aims to demonstrate that the IVD device produces clinically significant data associated with its intended use in the target population. It confirms that the device performs as intended in real-world clinical situations and facilitates appropriate clinical decision-making.
Our professionals help with the collection, evaluation, and documentation of clinical performance evidence using literature reviews, clinical studies, public data, and post-market information.
We help manufacturers develop a strong clinical evidence basis to support regulatory submissions and ongoing compliance.
Ongoing support to keep performance evaluation evidence current, accurate, and compliant throughout the product lifecycle.
Performance evaluation is a continuous process that goes beyond the original market approval. Manufacturers must regularly evaluate and update performance evaluation paperwork based on post-market surveillance findings, new scientific information, clinical evidence, performance studies, and regulatory developments.
We provide ongoing support for reviewing and updating Performance Evaluation Reports and accompanying paperwork to ensure that performance evidence is current, accurate, and in compliance with changing regulatory standards.
Our services assist manufacturers to maintain regulatory compliance throughout the product lifecycle while enabling continuing market access.
Practical EU MDR and IVDR support for Authorized Representative appointment, documentation handover, labelling updates, EUDAMED coordination, and continued market access.
FAQ
Yes. For applicable IVD devices, CDSCO requires Performance Evaluation Reports as part of the regulatory submission process to demonstrate the safety and performance of the device.
CDSCO requires Performance Evaluation Reports to be generated using three independent batches manufactured from different lots of key raw materials, such as antigens or antibodies.
Clinical Performance Evaluation is generally required for new Class B, Class C, and Class D IVDs. For Class A IVDs, it may not be required unless specifically requested by the Central Licensing Authority (CLA).
Performance Evaluation may be conducted at designated Medical Device Testing Laboratories (MDTLs). Where designated laboratories are unable to perform the evaluation, CDSCO may accept studies conducted by government laboratories, hospitals of national importance, or NABL-accredited laboratories, provided the studies meet applicable guidance requirements.
A Performance Evaluation Report typically includes product details, batch information, manufacturer details, testing methodology, reference standards used, sensitivity, specificity, positive predictive value, negative predictive value, accuracy, repeatability, reproducibility, and authorized laboratory signatory information.
Fill in the form and our team will get back to you shortly.
Reach our regulatory experts directly.