In the field of medical devices, ensuring compliance with regulatory standards is preeminent. Notified bodies play a crucial role in the approval process for CE mark, providing feedback on the technical file documents, most importantly, the Clinical Evaluation Report (CER).
A CER serves to demonstrate the safety and performance of a medical device when compared to the current state-of-the-art in medicine and competitor devices, and to show conformity with the General Safety and Performance Requirements (GSPRs). But what are the most common flaws found in CERs? What should manufacturers do to avoid them and increase their chances of CE mark approval?
Flaw #1: Many CERs fall short in conducting a comprehensive literature review of the current state of the art in medicine, either by missing relevant studies or by failing to critically appraise the quality of the included literature.
Solution: Manufacturers should ensure a thorough and up-to-date review of scientific literature, including a critical evaluation of study methodologies and relevance to the device in question. This comprehensive literature review should also include a thorough analysis of competitor devices, also known as benchmark devices or similar devices. Data from competitor devices can be used to set acceptance criteria for the safety objectives, performance objectives, and clinical benefits for the device under evaluation. Consecutively, the data from the device under evaluation can be assessed against the data from the competitor devices to determine whether the acceptance criteria have been met. Such a comparison requires statistical support for qualitative and quantitative analyses.
Flaw #2: Clinical evaluations often include limited clinical data on the subject device. The CERs rely too heavily on nonclinical data or data from devices that used to be equivalent to the subject device under the Medical Device Directive. Due to the more stringent criteria under the Medical Device Regulation, claiming equivalence is challenging and no longer an option for most manufacturers.
Solution: Manufacturers must prioritize the inclusion of relevant and sufficient clinical safety and performance data on their own device.
Flaw #3: Inadequate assessment of the device’s risk-benefit profile can be a critical flaw, with some reports failing to clearly demonstrate the favorable balance between risks and benefits.
Solution: A comprehensive risk-benefit analysis should be a central component of the CER, considering both short-term and long-term outcomes for patients. Such an analysis should be a combination of quantitative and qualitative methods. These methods should be clearly described and include a list of clinical parameters, based on the state-of-the-art in medicine, to determine the acceptability of the risk-benefit profile for the intended purpose and all indications of the subject device.
Flaw #4: Neglecting the importance of post-market surveillance data can result in an incomplete evaluation, as it provides valuable insights into the device’s real-world performance and safety.
Solution: Manufacturers should actively gather and analyze post-market surveillance data, incorporating it into the CER to demonstrate ongoing safety and efficacy.
Flaw #5: Some CERs lack a well-defined plan for post-market clinical follow-up activities to fill gaps that arise from the clinical evaluation.
Solution: To resolve those gaps, manufacturers should engage in targeted post-market clinical follow-up activities. Such activities are not limited to clinical investigations but can also include surveys, literature searches, and searches in public registries. Such searches should be directed towards the subject device and can also include the competitor devices. Those activities should lead to sufficient evidence in support of the clinical safety and performance of the subject device. Therefore, manufacturers should carefully plan and execute post-market clinical follow-up activities, adhering to appropriate methodologies and ensuring that the study design aligns with regulatory requirements.
Navigating notified body feedback for clinical evaluations requires a proactive approach from medical device manufacturers. Manufacturers can enhance the quality of their submissions by addressing common flaws, incorporating key considerations, and establishing clear acceptance criteria. This approach improves the likelihood of regulatory approval by notified bodies but more importantly, ensures that the medical devices on the market are safe and perform as intended.
If you need additional information or are looking for assistance with your CER, our expert team is here to help. Contact us today.