The literature search protocol and report can be the two most valuable aspects of a clinical evaluation for medical devices. Properly structured literature searches ensure a meticulous and complete search of the data to support clinical assessment of the device. The protocol will include what the authors want to do, search terms, databases searched and inclusion/exclusion criteria for searching literature as well as methodology in screening (selection of relevant articles). The resulting literature search report should detail these results and provide evidence of the safety and performance of the device by critically appraising all studies identified.
Objective: A detailed literature search protocol is only the beginning – start by determining what exactly you are looking for in a medical device, or whether or not it has documented safety, performance, and clinical benefits. Search terms and databases must be chosen to fully capture all relevant studies (including peer-reviewed journals, clinical trial registries, and regulatory databases). Inclusion and exclusion criteria are essential to minimize unrelated studies and enforce high-quality, well-relevant data capture.
Literature search report: These summarize the information available from selected studies and provide a comprehensive evaluation of the literature which supports clinical evidence for the medical device. This report is a critical component in the Clinical Evaluation Report (CER) which helps to show compliance with the requirements under various regulations and can help support your device’s approval onto the market.
Benefits of CER Gap Analysis for Manufacturers
CER Gap Analysis helps evaluate the current Clinical Evaluation Report (CER) according to regulatory expectations and best practices to identify gaps and potential areas of improvement. Manufacturers get many benefits from this analysis :
Gap Analysis for regulatory compliance It helps to ensure that the CER is in line with current and new regulations as applicable preventing any risk of non-compliance which could lead to delays right at the market approval phase.
Risk management: This enables you to evaluate the risk associated with your device which identifies gaps Bridging these gaps enhances the safety and efficacy profile of the device’s global quality.
Better Documentation: A comprehensive gap analysis results in better-structured and more detailed documentation, which provides a significant boost to the quality of CER.
Market Competitiveness – Manufacturers can secure a competitive advantage over peers in the market, as smooth regulatory approval processes result from building robust and compliant CERs.
Accountability: The card shows what are the best resources in certain projects, and which of them could be reallocated to others inside the same organisation.
Clinical evaluator
One of the most important parts is Clinical evaluators they are called clinical evaluation specialists or CERs, and this position plays a critical role in the medical device clinical assessment process. Some of their duties consist of
Literature review: Performing systematic literature searches and reviews to pull together all relevant clinical data on the device.
Data Interpretation -Formation of conclusions from clinical data regarding the safety and functionality of a device.
Create report writing: Create comprehensive clinical evaluation reports that are based on strict regulatory specifications.
Regulatory Compliance – Validate the CER meets regulatory body requirements, including European Medical Device Regulation (MDR).
Continuous monitoring Post-Market Clinical Follow-Up (the market is placed in quotes because the device already has a CE mark) to check that the device remains safe and working.
Benefits of appointing a CER Writer
The former, hosting a dedicated CER writer translates to the following benefits for manufacturers:
Specialized knowledge and experience: CER professional writers are well-versed in regulatory requirements and the clinical evaluation process.
Efficient: This is a key benefit because it can reduce the time that report preparation requires, as good CER writers know how to compile and present clinical data efficiently.
Expertise: Good writers make sure that the CER is well-framed, precise and compliant with regulatory standards.
Conclusion
A meticulous literature search protocol and report along with effective CER gap analysis are essential to successful medical device clinical evaluation. Employing clinical evaluators and CER writers, such as those at I3CGLOBAL, guarantees the procurement of top-notch compliant documentation instrumental in garnering regulatory approval and market success.
