First off, we will define the scope and strategic approach of the Clinical Evaluation. We will agree on a timeframe, including any deadlines that must be met. In this phase, we will exchange all necessary information.
In the early product development phase, we will carry out an initial evaluation according to the current State-of-the-Art. If a State-of-the-Art document is already available, we will review and update it, if necessary.
Next, we will create a Clinical Evaluation Plan (CEP), including a Clinical Development Pan (CPD). Alternatively, if necessary, we can also update your existing CEP according to the lifecycle phase of your medical device.
In this phase, we will perform a thorough search on medical background, similar devices and medical alternatives in medical literature and guideline databases.
We will identify clinical and non-clinical data as well as data from relevant clinical device and fully document all our database searches.
Following the data identification phase and extensive literature search, we will evaluate the data we have found, which includes data extraction from scientific publications and quality assessment (e.g. level of evidence).
Our analysis includes the evaluation of all data according to the relevant General Safety and Performance Requirements (GSPRs) of the medical device, as well as grouping the data into a Body of Evidence for your device.
Finally, all activities and data will be summarized in a Clinical Evaluation Report (CER). During device development, the CER helps to identify data gaps and plan necessary clinical trials. For conformity assessment (CE marking) of the device, the CER must be updated and sufficient data must be available to demonstrate safety and performance. An (annual) update of the CER to include new data from PMS/PMCF activities and other sources, or when relevant changes are made to the design of the device, will also be performed.