Clinical Evaluation Report

Clinical Evaluation Report

A Clinical Evaluation Report (CER) documents the conclusions of the clinical evaluation of a medical device at a certain time. It consists of analyzed clinical data from previous studies and publications and demonstrates that this device achieves its intended purpose and that the balance benefit/risk is positive. Regular updates to CERs are required as part of the post-market surveillance to document any changes that may impact previous conclusions.

Medical and regulatory documentation developed by experienced medical writers plays a pivotal role in the success of a clinical research project. Our medical writing team works closely with key operational departments including Biostatistics, Analytics, Medical Affairs, and Clinical Operations to produce comprehensive and fully integrated deliverables.

High-Level Clinical Expertise Assisted by Technology

The Medical Device regulatory landscape is constantly evolving. This requires development of agile and innovative technologies. Through ELCEVAR MedTech, ECLEVAR is developing methods that semi-automate several steps of the CER pipeline via machine learning. We have developed state-of-the-art natural language processing (NLP) algorithms to drastically reduce the time and costs required to produce standard CERs while enhancing comprehensiveness and quality.

Our technology accelerates the work of medical writers and enables them to harness and focus their expertise and experience to produce high-quality standard CERs. Automation help them expedite most steps of the systematic review process including search, screening and data extraction.

Our Methodology

A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:

  1. a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device.
  2.  a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
  3. a consideration of currently available alternative treatment options for that purpose.

Our offering

Write your CER

Preparing a new CEP and CER

Update your existing CER

Do you need help updating your CER with PMS and PMCF data?

GAP-analysis

Conducting a gap analysis of your existing CER aiginst MDR

Upgrade your existing CER

To comply with the recent regulatory requirements

CEP / CER Training

Training your staff on how to write, improve CER preparations or review

Clinical Expert Review

A literature review is a mandatory part of each Clinical Evaluation.

How can we help you?