Overview
In the ever-evolving landscape of medical device regulations, Elexes undertook a transformative journey with a renowned cochlear implant manufacturer, to craft a meticulous Clinical Evaluation Report (CER) adhering to the stringent requirements of the EU MDR.
Problem Statement
Prior to engaging with Elexes, the Client faced significant challenges in navigating the complexities of the EU MDR requirements for the creation of a Clinical Evaluation Report (CER) for their cochlear implants.
- DEFINING DEVICE FEATURES AND ALTERNATIVES
- CRAFTING THE CLINICAL EVALUATION PLAN
- LITERATURE SEARCH EXCELLENCE
- INTEGRATION OF REGULATORY COMPONENTS
- ACCELERATED CE MARK ACQUISITION
Literature Search Excellence
Recognizing the significance of a thorough literature search, Elexes navigated various databases such as PubMed, Embase, and Cochrane Library. This approach ensured a comprehensive review of existing data, contributing to a more informed CER.
Integration Of Regulatory Components
Elexes seamlessly integrated Post-Market Surveillance (PMS), Post-Market Clinical Follow- Up (PMCF), Safety and Performance Report (SSCP), and Periodic Safety Update Reports
(PSURs) into the fabric of the CER. This holistic approach not only met regulatory mandates but also fortified the clinical evidence supporting the cochlear implant’s safety and efficacy.
