Clinical Evaluation

Achieving a successful submissions is a complex and crucial challenge. In collaboration with your teams, Eurofins Medical Device Consulting can overcome any issue you might face to optimise your Clinical Evaluation (CE) content and time management.

The Clinical Evaluation Plan (CEP) is the first step in finding the best approach to conduct the CE, in accordance with guidelines and regulations.

The CEP defines:

• Scope of the CE
• Clinically relevant standards
• Criteria:
  • Inclusion/exclusion criteria of the clinical data retrieved for the clinical evaluation of the device
  • Criteria for the appraisal of pertinent data.

The CEP identifies relevant documentation and data to support the CE.

The CEP proposes:

• A clinical development plan, indicating the progression from exploratory investigations to confirmatory investigations
• A Post-Marketing Clinical Follow-up (PMCF) as appropriate.

In line with the CEP, a Clinical Evaluation Report (CER) is provided to identify the relevant clinical background and the State of Art necessary to perform a correct evaluation and analysis of clinical data on the device. Thanks to data analysis, the CER reports a clinical development plan, indicating the progression from exploratory investigations to confirmatory investigations and a PMCF as appropriate. It summarises the strategy and results of the clinical evaluation together with overall conclusions on the safety, performance and benefit/risk profile of the medical device.