Case Report: Single Use Products
Our client is a medium-sized, leading manufacturer of single-use products. Our goal was to create a clinical evaluation in sampling for the existing approval under the Medical Device Directive (MDD) according to the MDR criteria. This case report describes our approach to successfully carrying out the company’s first MDR transition in the field of clinical evaluation.
Analysis of the Current Situation: At the beginning, we conducted a thorough analysis of the current situation. We reviewed the existing clinical data and documents. This helped us identify existing data gaps and the necessary updates.
Determination of Clinical Strategy: Based on the findings from the current situation, we developed a clinical strategy for implementing the MDR requirements.
Research Creation: To be able to conduct a well-founded clinical evaluation, we carried out comprehensive research.
Adjustment of the Intended Purpose: An important step in implementing the MDR transition was adjusting the product’s intended purpose. We reviewed the existing intended purpose according to MDD and updated it according to the new MDR requirements.
Creation of Clinical Evaluation: Based on the collected data, the adjusted intended purpose, and the MDR requirements, we created a comprehensive clinical evaluation according to MDR. This evaluation included the analysis of existing data, the review of conformity with MDR requirements, and a detailed risk assessment. Otherwise, all relevant aspects of the product’s c performance and safety were taken into account.