Search
Close this search box.
Logo Asphalion
Clinical Evaluation Report (CER)

Key Tips for Drafting a Compliant Clinical Evaluation Report (CER)

Aspects to be considered and practical tips for writing a compliant clinical evaluation report (CER)

Aspects to be considered and practical tips for writing a compliant clinical evaluation report (CER)
August 10, 2023

💡CLINICAL EVALUATION REPORT

In the realm of medical devices, a well-structured Clinical Evaluation Report (CER) is an indispensable document that scrutinizes pre-market and post-market clinical data. It assesses both clinical performance and safety, offering a comprehensive evaluation of relevant clinical data to ensure the device’s adherence to regulatory requisites. In this post we will give you some aspects to consider and practical tips for writing a compliant clinical evaluation report. Interested? Keep on reading.

 

Stage 0: SCOPE AND PLAN

Understanding the anticipations of a Notified Body for medical devices is paramount. A solid starting point is employing the Clinical Evaluation Report template (MDCG 2020-13) developed by the MDCG Group, which outlines the essential sections and details necessary for a Notified Body submission. Additionally, leverage available guidance, including typical specifications, MDR harmonized standards, international standards, and MDCG guidance documents. Remember, quantifying your benefit-risk ratio substantiates your performance claims effectively.

 

Stage 1: IDENTIFICATION OF THE DATA

Discerning between pre-market and post-market clinical data is crucial. Classifying these data sets, including clinical data from investigations and other sources, ensures a well-structured CER. For data that doesn’t fit these categories, a rationale should be provided for its inclusion.

 

Stage 2: APPRAISAL OF CLINICAL DATA

Thoroughly assess each identified data set for scientific validity and relevance to the clinical evaluation. To ensure a comprehensive assessment, use at least two literature and adverse event databases. This approach offers a holistic understanding of the device’s safety and performance within the market landscape.

 

Stage 3: ANALYSIS OF CLINICAL DATA

The analysis phase encompasses key elements such as the benefit-risk profile, residual risks, and uncertainties or unanswered questions. A comprehensive exploration of these aspects contributes to a robust evaluation.

 

Stage 4: FINALIZING THE CER

Concluding the data analysis phase, the CER should succinctly summarize the findings. This summary plays a pivotal role in presenting compelling clinical evidence to facilitate the device’s approval for European market distribution. This final stage encompasses a range of data sets, including:

  • Technical documentation
  • Post-Market Surveillance (PMS) reports
  • Post-Market Clinical Follow-up (PMCF) data
  • Risk management files
  • Clinical data
  • Clinical literature

 

Be OBJECTIVE. Every assertion made within a clinical evaluation report should be firmly grounded in scientific evidence. Objectivity is paramount; therefore, ensure that each claim is substantiated by accurate references.

 

Drafting a compliant Clinical Evaluation Report demands meticulous planning, a keen understanding of regulatory expectations, and a judicious assessment of clinical data. Following these practical tips can significantly enhance the quality of your CER, ultimately leading to successful approval for European market distribution.

📌For more information about our comprehensive clinical evaluation process services, please contact us at info@asphalion.com. Our team of experts is dedicated to ensuring your medical device regulatory compliance journey is seamless and successful.

Search News & Events

  • Filter by category

Share

Related news and events

NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting