2022 for IVDR compliance is not far, though it gives a perception of “enough time”
Based on the risk class, requirements for clinical evidence increase to support the safety and performance of your products
Performance Evaluation
From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER)
Some of the questions that these reports need to address:
- Were clinical performance studies and tests performed to prove a device is effective and safe?
- What analytical tests were performed and what standards are used?
- What recorded evidence exists for the device?
- What research has been conducted on the device and it’s intended purpose?
- What state-of-art the device corresponds to?
MakroCare with a global team of 90+ Clinicians, Diagnostic technologists, Micro Biology associates, Writers, and Scientific experts can help you achieve your Performance Evaluation goals, on time with scalable competitive cost models (unit, hourly, fte)
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