In EU MDR, clinical data plays a crucial role in evaluating the safety and performance of the subject devices. However, deficiencies in clinical data can arise, leading to the need for further investigation and evidence collection. In this blog post, we will explore a recent deficiency related to indications and the subsequent response involving Post-Market Clinical Follow-up (PMCF).
Deficiency: Lack of Differentiation in Clinical Data
A deficiency was identified regarding the justification of sufficient clinical data on the endpoint of bone consolidation. The deficiency highlighted the lack of differentiation between different indications and sub-types (e.g. fracture types). This raised concerns about the comprehensiveness and specificity of the clinical evidence provided.
Response: Detailed Information and PMCF Plan
To address this deficiency, the response included the addition of more detailed information on indication and fracture types in the Clinical Evaluation Report (CER). This involved the inclusion of tables presenting demographic information, the number of patients treated per indication, and AO fracture classifications per study.
However, it was also acknowledged that there were low numbers of cases for rarer indications, such as pathologic fractures, impending pathologic fractures, tumor resections, non-unions, and pseudoarthroses of the femur. To gather further evidence and address these deficiencies, a specific Post-Market Clinical Follow-up (PMCF) activity was established.
PMCF: Gathering Additional Evidence
The PMCF activity, initiated and conducted by the Investigator and financially sponsored by the manufacturer, aims to collect additional clinical data. An interim study report is being finalized by the Investigator and will be provided to the manufacturer upon completion. The data and findings from this PMCF activity will be analyzed and included in the next periodic update.
Importance of PMCF in Addressing Deficiencies
Post-Market Clinical Follow-up (PMCF) is a crucial aspect of ensuring the ongoing safety and effectiveness of medical devices. It allows for the collection of real-world data, identification of potential issues, and the gathering of additional evidence to address deficiencies. In this case, the PMCF activity will provide valuable insights into the performance outcomes and safety of the device, specifically focusing on the rarer indications.
Conclusion: Addressing deficiencies in clinical data is essential for demonstrating safety and performance of medical devices. The response to the deficiency regarding indications involved the inclusion of more detailed information in the CER and the establishment of a PMCF activity. This demonstrates the commitment of the manufacturer to gather additional evidence and ensure the ongoing evaluation of the device’s performance. Through PMCF, valuable insights will be gained, contributing to the continuous improvement of the device.
*Disclaimer: Please note that the information provided in this blog post is based on the given context and past experience and may not apply to your specific situation as each audit and submission is unique.