European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturers fall under the purview of the regulatory framework, which is established to provide confidence to the clinicians, and the patients that the medical and implantable devices used in the region have been validated for their potential benefits and certified as safe for usage. The European regulatory framework’s MEDDEV guidelines promote a uniform approach to the conformity assessment procedures for the medical device manufacturers and the notified bodies associated with the evaluation process. MEDDEV 2.7.1 Rev 4 guidelines provide guidance relating to the proper evaluation of clinical safety and the performance of the medical devices for the manufacturers.
Clinical Evaluation Report (CER) is an important document that is a part of the conformity assessment process, which is carried out throughout the life-cycle of the device. The CE reports provide conclusive information about the clinical safety and the performance of the medical device by bringing together all relevant clinical data and making proper analysis of the data.
CER and Pre-market phase
Clinical evaluation is undertaken in the initial phase of the conformity assessment, which is conducted for the purpose of obtaining CE mark, the marketing license to market the products in the European Union region.
The CE report needs to be revised periodically to update the concerned authorities whenever the manufacturers have made changes to the device’s design, manufacturing process or its intended use. The CER is also needed to inform the authorities about the risk analysis of the device, which is done to identify potential risks and areas of concern, and to update them on the risk mitigation measures undertaken by the manufacturers.
CER and Post market phase
In the post-market phase, clinical evaluation of the device is continued with the maintenance of surveillance programs to monitor device safety and performance. The updated CER can include adverse incident reports, results from published literature reviews on the actual device or similar products, and clinical investigations.
Post Market Clinical Follow-up (PMCF)
The medical device’s clinical data collected during the pre-market phase may be too limited and might not be sufficient to identify events or incidents with rare occurrence. Post Market Clinical Follow-up involves an ongoing collection of clinical data based on the user experience of the device after its introduction in the market. Regulatory requirements mandate medical device manufacturers to conduct Post Market Surveillance plan that includes PMCF with the objective of identifying new risks that cannot be predicted during the pre-market phase. The manufacturers needs to analyze the clinical data obtained from the PMCF to arrive at meaningful conclusions about the benefits and the risks of the device. They also have to report the current understanding to the relevant authorities in CER on a periodic basis.
CE report is needed to update the results of the Post-market Clinical follow-up along with the vigilance and complaints to comply with the regulatory requirements.
Thus, CE Report is an important prerequisite for introducing and continuing to market medical devices in European Union regions, which requires high expertise and sufficient time allocation for initial preparation and subsequent updating process.
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