Clinical Evaluation is a process to collect and assess all clinical data relating to a device and to evaluate whether there is sufficient clinical evidence to demonstrate conformity to the relevant regulatory requirements. This process and its results are documented in a Clinical Evaluation Report. Clinical Investigations are clinical studies (trials) in one or more human subjects, undertaken to assess the safety or performance of a medical device.
A clinical investigation is often the keystone of evidence to prove that your medical device is ready to enter the market. Results of the investigation will be input for your clinical evaluation to demonstrate compliance to regulatory requirements on safety and performance. Before initiating a clinical investigation, you should stop and think what the scope of this investigation should be, and if a clinical investigation is actually necessary.
To determine if a clinical study is required, it is important to look at the complete body of evidence that you plan to submit to the Notified Body. The evidence should support safety and performance of your device, as well as any specific clinical claims you make for your product. The full package of evidence will consist of data from:
- Verification tests showing the device meets the design requirements;
- Tests showing compliance to (recognized) product standards;
- Usability, bench tests or animal studies to evaluate risks and performance before going into the patient (pre-clinical data);
The outcome of this (clinical) evaluation will be either that the available data is sufficient, or that an additional clinical investigation is warranted (MEDDEV 2.7/1 A2); If there were any remaining questions these will set the scope of your study.
A clinical evaluation
of all available clinical and pre-clinical data is both a requirement from Good Clinical Practice (ISO14155/GCP) before you initiate a study, as well as a regulatory requirement for market entry (MDR article 61). You may find that bench-tested compliance to standards provides full (e.g. ECG amplifiers) or partial evidence (e.g. guidewires) for safety or performance.
Certain device risks or performance aspects may very well be evaluated in simulated clinical procedures or animal models. Optimising the use of pre-clinical data will provide a clear focus for your clinical data collection.
Both from an ethical and business perspective there is a need to very carefully consider what aspects of safety and performance need to be evaluated in humans, and which can be supported by pre-clinical evidence. Only (clinical) evaluation of the total set of available data will provide you the answer to getting the leanest, safest and most effective setup for your clinical investigation.