Clinical Data for a medical device appraised in stage 2 of the clinical evaluation process should be analyzed in stage 3 to demonstrate compliance with all the Essential Requirements confirming the safety and performance of the device during its use for the intended purpose. In order to demonstrate compliance, the clinical evaluators should follow some specific considerations, such as sound methods, making a comprehensive analysis, determining additional clinical investigations and PMCFs if required.
- The methods available for analyzing clinical data are mostly qualitative or quantitative, depending on the nature of the medical device and the circumstances. Qualitative methods are more reliable.
- Make a comprehensive analysis by determining compliance with each of the Essential Requirements pertaining to the safety, acceptable benefit/risk profile, and performance of the device, which are explained in detail below:
Conformity assessment with requirements on safety in accordance with MDD ER1 / AIMDD ER1. The information provided by the manufacturer, including IFU, labels, and other promotional materials, should be reviewed to ensure consistency with clinical data appraised in stage 2, and all related hazards, risk mitigations, and other clinically significant information should be identified.
Conformity assessment with requirements for an acceptable benefit/risk profile per MDD ER1 / AIMDD ER1. Any risks associated with the intended purpose must be low and acceptable when weighed against the patient’s benefits, and they must be compatible with a high level of protection for their health and safety. Following points needed to keep in mind:
- The IFU perfectly describes the device’s intended use and demonstrates it with sufficient clinical evidence.
- IFU must contain correct information, like handling instructions, descriptions of risks, warnings, precautions, contraindications, instructions for managing foreseeable unwanted situations to reduce the risk and their management and needs to be supported by sufficient clinical evidence.
- A description of the device’s intended purpose and the device’s benefits to the patient should be reviewed per the IFU provided by the manufacturer and supported by sufficient clinical evidence.
- Evaluation of the clinical risks of devices should be performed by description of risk management, incidents reported in PMS, and also the extent of risk, which includes the nature of severity, number, and rates of adverse events.
- Assessment of the risk-benefit profile’s acceptability.
Conformity assessment with requirements for performance: The ability of the device to achieve its intended purpose should be demonstrated, including direct or indirect effects, along with clinical benefits. The clinical data of the device achieves its intended performance during normal conditions of use.
Conformity assessment with requirements on acceptability of undesirable side- effects is done by weighing acceptable undesirable side effects against the intended performance. The acceptability of the side effects of a device should be evaluated on the basis of the information given below:
- Evaluation of clinical data on the nature, severity, and frequency of the side effects.
- The clinical data should include a sufficient number of observations (e.g., from clinical investigations or PMS) to ensure the scientific validity of the findings about unfavorable side effects and device performance.
- To determine acceptability, consider the state of the art, properties of benchmark devices and medical alternatives, and objective performance requirements for standards.
Additional clinical investigations or other measures are necessary to determine if they are needed in order to generate any missing data and eliminate compliance difficulties.
To determine the PMCF’s requirements, assessors should describe all residual risks, uncertainties, or unanswered questions.