Evaluation Strategy Tailored to Your Device

Clinical Evaluation Plan

Proper planning is key to success – this also applies to clinical evaluation. A carefully prepared Clinical Evaluation Plan (CEP) enables finding the most efficient strategy for the clinical evaluation of legacy devices. For new developments, a CEP helps define the clinical benefit of the device and establish it based on the current state of the art. Additionally, it helps identifying open questions that need to be addressed through clinical data.

• Description of the state of the art
• Definition of safety and performance parameters based on this state of the art
• Evaluation of available data sources for your device

Clinical data serves as the cornerstone of nearly all medical device clinical evaluations. This data may come from published clinical literature about the device itself, equivalent devices, or from Post-Market Clinical Follow-Up (PMCF) activities and clinical studies.

Our literature analysis follows a systematic, transparent, and methodologically rigorous approach. Since the MDR came into effect, the evaluation of individual sources (Literature Appraisal) and documentation of search results have become increasingly important. At novineon, we've developed streamlined processes that minimize administrative burden while maintaining comprehensive documentation.

• Systematic and reproducible literature search
• Evaluation of all data sources according to current regulatory requirements
• Concise documentation of the literature search and its results

The Clinical Evaluation Report (CER) serves, among other purposes, to demonstrate conformity with the General Safety and Performance Requirements (GSPR).

Within the CER, we thoroughly assess the safety, performance, and risks associated with your medical device. This assessment incorporates data from instructions for use, device specifications, technical testing results, proprietary clinical data, and published literature. The critical focus is on weighing clinical benefits for the patient against potential risks, using the safety and performance parameters established in the CEP.

We carefully align any risks identified during clinical data analysis with your risk management documentation and instructions for use. Regulatory compliance demands consistency across these three key documents. We identify any outstanding questions regarding the benefit-risk ratio of the device, which might be resolved through future PMCF activities.

• Comprehensive assessment of device safety and performance using parameters defined in the plan
• Verification of technical documentation consistency
• Documented evidence of GSPR compliance