Update Your Clinical Evaluation Report
Clinical evaluation is essential because it assures that, during the entire time a medical device is on the market, assessments of its performance and safety are supported by enough clinical data. For first-time CE-marking, a clinical evaluation is required, and it needs to be actively updated.
For the duration of the device’s life cycle, the clinical evaluation and its documentation should be updated with clinical data from the post-market surveillance system (PMS) and post-market clinical follow-up (PMCF). The frequency of updates is determined by your device’s risk categorization and the PMS’s output.
Why Frequency of Updates in Clinical Evaluation
The manufacturer must specify and justify how frequently a clinical evaluation is required. The following are typical factors that the manufacturer should consider when doing this:
- Whether the device carries any significant risks.
- Whether the device is well-established while considering.
- Innovation, alterations
- Consider the information available from clinical investigations, PMCF studies, registries, or other systematic studies or the total number of devices currently in use on the market and anticipated vigilance system reporting rates.
- Whether there are short-term, long-term, or intermediate-term hazards or uncertainties or any modifications to production processes or design.
The clinical evaluation is update when the manufacturer obtains the latest information from PMS. If no such information is obtained, then a rationale should be given at least every year if the device carries major risks or is not yet well established or every two to five years if the device is not anticipated to cause significant hazards.
General Considerations on Updating the Clinical Evaluation Reports
Manufacturers are expected to set up and maintain a post market surveillance system that routinely tracks the clinical effectiveness and safety of the device. The clinical evaluation and the evaluation report must be routinely updated with post-market surveillance in compliance with the directives.
The evaluators should confirm the following when revising the clinical evaluation:
- Whether the benefit/risk profile, unfavorable side- and risk mitigation strategies are still,
- compatible with a high degree of health and safety protection and acceptable based on current knowledge and the state of the art.
- accurately addressed in the information materials and current PMS plan provided by the manufacturer.
- Whether the already made claims and proposed new claims are justified.
If the manufacturer determines there is insufficient clinical data to certify compliance with the essential requirements, then the manufacturer will need to stop marketing the devices until conformity is restored and take the required corrective and preventative actions.