Clinical Evaluation Report

In the highly regulated medical device industry, a Clinical Evaluation Report (CER) is essential for demonstrating the safety and performance of medical devices. We offer specialized Clinical Evaluation Report consulting services to help medical device manufacturers navigate the complex requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

With CERT3Global, you benefit from expert guidance, tailored solutions, and seamless regulatory compliance, allowing you to focus on innovation and patient care. Trust us to be your partner in achieving successful CE marking through robust clinical evaluations.

A Clinical Evaluation Report for Medical Devices is a Compilation of all the clinical data gathered during Clinical Evaluation. It is mandatory to obtain if you want to market your devices in the European Union. [Clinical data is the safety and performance knowledge generated from the use of a medical device]

It shows the clinical evidence for the device’s efficacy in treating the claimed disorder, condition, or disease the patient may have while ensuring their safety respectively. This is the core objective and serves as a vital component in the regulatory process for Medical devices in Europe (MDR)

A clinical Evaluation Report is required for all medical devices (except for custom-made devices) in the EU and is a major part of the Medical Device Regulation (MDR) 2017/745 Technical Documentation, which is essential for getting a CE marking for a device (which is needed for marketing your devices in the European Union).

Clinical evaluation is an ongoing process, and the CER being a ‘living’ document has to provide periodic snapshots of medical devices’ performance on patients or (if any) over time. Also when new clinical data is available or there is a change in the device’s intended use or technology. If the manufacturer becomes aware of any (PMS) Pre Market Surveillance or (PMCF) Post-Market Clinical Follow-Up data that could affect the current evaluation or its conclusions.

Without Clinical Evaluation, there can be no Clinical Evaluation Report. Continuous generation, collection, analysis, and assessment of the clinical data of a device with the objective of verification of safety and performance when the medical device is used as per the intended purpose. The Main Objective of the Clinical Evaluation Report for Medical Devices is to show compliance with the general safety and performance requirements and fulfilment of the intended use. It begins at the development stage and continues throughout the device lifecycle.

You know that CER is an important and complex process to go through before starting to market your medical devices legally in Europe. For a smooth sail through the intricacies of CER, our team has helped many manufacturers (whether small, medium, or big) across the globe. Reach out to us and we will help you in a personalised way to ensure your Clinical Evaluation Report is a quality one.

A CER report writing is a very crucial step in your regulatory filing process and it is best left to a Consultant who has a team of experienced medical writers and regulatory experts. It is essential that the Consultant is reliable and uses best practices to ensure your Evaluation Report gets approved.

Cert3global has worked on many successful CE Mark applications and our team will work closely with your company to ensure your products comply with EU Legislations and guidelines. For any query regarding the preparation of a Clinical Evaluation Report or CE marking, reach out to us.