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Clinical
Evaluation Report

The EU Medical Device Regulations(MDR) 2017/745 states that a Clinical Evaluation Report is essential for all medical devices and is a major part of Technical Documentation. Its main objective is to show that the device fulfils its claimed promise with a safe benefit-to-risk ratio for the intended purpose. This page aims to provide you with a crucial overview of CER if you are looking to market your Medical Device in the European Union.
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What is a CER?

  • Definition
    • 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]
  • Significance
    • 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)
  • Is it Mandatory?
    • 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).
  • CER is a Continuous Process:
    • 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) PreMarketSurveillance or (PMCF) Post-Market Clinical Follow-Up data that could affect the current evaluation or its conclusions.

What is Clinical Evaluation?

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.

Cert3global: Team of Experienced Medical Writers and Regulatory Professionals

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.

Why is CER Required?

  • For the Manufacturer to obtain CE Marking, the Evaluation Report is crucial as it serves as proof that the device meets the regulatory standards set out by the European Medical Device Regulations(MDR) (which aims to ensure the safety of patients)
  • Demonstration of efficacy and clinical results when used as intended by the manufacturer.
  • Ensures that the device has an acceptable risk-benefit ratio for its intended purpose./li>
  • Serves as a validation of whether the claims mentioned by the manufacturer match the actual result.
  • The Clinical Evaluation aims to provide an independent opinion on the clinical safety and performance of the product.
  • For conformity of compliance with relevant safety and performance requirements. It is a one-stop source for comprehensive analysis of premarket and postmarket clinical data relevant to a medical device.

Clinical Evaluation Report Consultant

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.

Clinical Evaluation Report Consultant

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.

What are the Contents of a CER ?

The Contents of the Report vary from device to device and are different for every device according to their regulatory demands and the nature of the risk they possess.
However, there are general contents which are to be included in the report to ensure the report is exhaustive:
  • Basic Info
    • Device’s intended to use information, Classification, and Regulatory History along with a summary of clinical background.
  • Clinical Data
    • From the Clinical Investigation of the concerned device or an equivalent device. Relevant post-market surveillance (PMS) data with emphasis on post-market clinical follow-up (PMCF)
  • Scientific Literature
    • – Studies reported in the scientific literature for an  equivalent device
    – Peer-reviewed reports on the clinical experiences of the concerned or equivalent device
  • Summary of
    • Device usability and Non-clinical testing data, benefit-risk determination, sales, complaints, clinical data held by the manufacturer, and other post-market surveillance data.
  • Other Data
    • Conclusions, Evaluator qualifications As mentioned, the list is not exhaustive, you can contact our team to know more personalised requirements for your particular device.

Best Clinical Evaluation Report Consultant

A thoroughly prepared Clinical Evaluation report by a competent Authority is the surest way possible for smooth regulatory sailing in the growing European Union Market. We at Cert3global have the experience and expertise to develop and regularly update your Report with high-quality practices and a streamlined writing process, which is done by our proprietary Technology. Contact Us now and we are happy to help you.

Conclusion

For any medical device manufacturer looking to market their products in the European Union Market which is estimated to be worth $122 billion each year in Revenue and accounts for more than 30% of the market worldwide, we at Cert3global are a team that can be relied upon for your Products to be marketed legally in the EU.