Clinical Evaluation is the process of collecting and assessing all clinical data related to a device and evaluating whether sufficient clinical evidence exists to support conformity with regulatory requirements. The clinical investigation is often the most important evidence needed to prove your medical device is ready for market.

1. Where do Clinical Evaluation and Clinical
Investigation intersect?
Clinical Evaluation is the process of collecting and assessing all clinical data related to a device
and evaluating whether sufficient clinical evidence exists to support conformity with regulatory
requirements. A Clinical Evaluation Report documents the process and its findings. Clinical
Investigations (trials in human subjects) are used to evaluate the safety and performance of
medical devices.
The clinical investigation is often the most important evidence needed to prove your medical
device is ready for market. The investigation results will provide your clinical evaluation input to
show compliance with regulatory requirements regarding safety and performance. Before you
begin a clinical inquiry, it is important to consider the scope of the investigation and whether a
clinical investigation is necessary.
It is crucial to review all evidence submitted to the Notified Body to determine whether a clinical
trial is necessary. Evidence should support the safety and performance of your device as well as
any clinical claims that you may make about your product. Data from:
- Verification tests to verify that the device meets design specifications.
- Testing that shows compliance with (recognized product standards);
- Preclinical data: Bench tests, usability and animal studies that evaluate risk and performance of
the patient before they are admitted to the clinic.
This clinical Evaluation will determine whether the data are sufficient or if an additional clinical
investigation should be conducted (MEDDEV 2.3.1 A2). If any questions remain, these will
define the scope of your research.
A clinical assessment of all clinical and preclinical data before you start a study is required by
Good Clinical Practice (ISO14155/GCP). It also serves as a regulatory requirement for market
entry (MDR Article 61). Bench-tested compliance with standards may provide full (e.g., ECG
amplifiers) and partial evidence (e.g., Guidewires are used for safety and performance.
Simulated clinical procedures and animal models may evaluate certain device risks and
performance aspects. Optimizing preclinical data can help you focus your clinical data
collection.
From both a business and ethical perspective, it is important to carefully evaluate which aspects
of safety and performance should be evaluated in humans. This can also be supported by
preclinical evidence. Only a clinical evaluation of all available data can provide the best solution
for your clinical investigation.
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