Clinical and Performance Evaluation Process (CEP/CER – PEP/PER)

Clinical evaluation for medical devices (MD) and performance evaluation for in vitro diagnostic medical devices (IVDs) are essential elements for obtaining and maintaining CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). CEP/CER and PEP/PER documents must be scientifically robust, continuously updated, and fully integrated into the company’s quality management system.

We offer a comprehensive service for the drafting, review, and updating of CEP, CER, PEP, and PER documents, aligned with the latest regulatory requirements, MDCG guidelines, and notified body expectations.

• Clinical Evaluation Plan (CEP) e Clinical Evaluation Report (CER): Analysis of the intended use and classification of the device; evaluation of available clinical data and gap analysis; PMCF (Post-Market Clinical Follow-up) planning and drafting of the CER in accordance with guidelines..
• Performance Evaluation Plan (PEP) e Performance Evaluation Report (PER): Support in the scientific, analytical, and clinical assessment of performance as per IVDR; strategies for IVDs with predictive purposes or integrated algorithms; assistance with clinical data generation and collection; PER drafting in line with applicable guidelines.

Why choose FTR ADVISOR? Because we rely on a methodology grounded in scientific evidence, consistency with the literature, and a proactive approach to the device lifecycle..