Wound Market Consulting

Clinical Evaluation Report

Clinical Evaluation Report

If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with MDR-EU 2017/745 expected to be in force 26th May 2021 and MDD-Council Directive 93/42/EEC of 14 June 1993.

Clinical evaluation reports are an important element in obtaining and maintaining CE Mark. A compliant CER should provide strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.

CERs require a high level of personnel time that may stretch the capacity of some companies working to ensure MDR Compliance. Wound Market Consulting offers a bespoke outsourcing service to help you meet your deadlines.

We can…

  • Collect and analyse the appropriate scientific literature applicable to your device
  • Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER
  • Develop a protocol to methodologically search and evaluate journal articles and provide a synopsis
  • Compile and draft the CER in compliance with EU Regulatory requirements
  • Review the final draft by a Senior Regulatory Director