CHALLENGE:
In March 2022, our client sought EU MDR 2017/745 compliance and CE-marking for their single use overtube. The product was intended to be used with an endoscope for intubation, changing endoscopes, and/or treatment in the gastrointestinal tract in adults. Clinical evaluation planning and reporting was an area where support was needed. Navigating the EU MDR regulation is complex and requires up-to-date awareness of the guidances that are still being issued. Given the complexity of the regulation, and without internal resources with the knowledge or experience, our client chose AlvaMed to support their EU submission.
Clinical evaluation is a critical part of an EU submission and the EU MDR outlines requirements for Clinical Evaluation Planning (CEP), Clinical Evaluation Reports, Literature Searches and Analyses, Clinical Studies, and Post-Market Clinical Follow-up. The AlvaMed team has the detailed understanding of the requirements, and the experience with Notified Body reviews, necessary to complete all of these aspects in a compliant manner.
APPROACH:
AlvaMed’s team of clinical and regulatory specialists drafted the Clinical Evaluation Plan, defining the scope, objectives and methodology for the clinical evaluation ensuring compliance with EU MDR requirements. Once approved, AlvaMed completed the activities defined in the CEP:
- Literature Searches: Identified and analyzed relevant scientific data.
- Post-Market Clinical Follow-up Plan: Outlined a proactive approach to gathering real-world clinical data.
- Literature Search Report (with pdf articles and appraisal documents): Delivered a comprehensive analysis of identified studies, including individual appraisals.
- Clinical Evaluation Report: Integrated all findings into a cohesive report, demonstrating device safety and performance.
RESULTS:
Through our collaborative approach, the client received a robust clinical evaluation package, positioning them for a smooth path towards EU market access. All components of the Clinical Evaluation were completed within the time and budget needed by the client to keep their submission goal on target. The client successfully received the CE mark and 510(k) clearance.
IMPACT:
This case study exemplifies AlvaMed’s ability to guide clients through intricate regulatory landscapes, ensuring compliance and accelerating market entry.
KEY TAKEAWAYS:
- Navigating the EU MDR’s clinical evaluation requirements can be challenging.
- AlvaMed’s expertise simplifies the process and ensures regulatory compliance.
- AlvaMed streamlines the clinical evaluation process through our collaborative approach and the use of data analysis tools such as AI.
- Our comprehensive approach delivers high-quality clinical evaluation packages.
