Clinical Evaluation Report

Medical Device Clinical Evaluation Report


Medical Device Clinical Evaluation Report as per MEDDEV 2.7/1 Rev 4 is considered as a tool to provide the Notified Bodies with a complete overview of the continuous evidence of safety and performance for the Medical Device.

During the clinical evaluation process, all data that could provide information on the safety and performance of the medical device is analyzed and assessed.

Due to this reason developing and maintaining clinical evaluation medical device report became a higher priority for CE Marked manufacturers across the globe.

A good Clinical Evaluation Report report should support strong evidence that your device achieves its intended purpose without exposing users and patients to risk.

The CER Report must be based on data, which may include data from existing literature, human usage experience, human trials, or any combination of the three.

Compared to earlier Rev 3, MEDDEV 2.7/1 Rev 4 has some more requirements that are very difficult to interpret and those new. It may cause delays in the Notified Body review process if just updating based on literature strategy without Equivalence device analysis will increase your risk of rejection of report by Notified Bodies..


We offer the right strategy starting with GAP analysis of your existing CER report. If required we are here for you to take up the job for updating your present report or develop a new Evaluation report as per Meddev 2.7/1 Rev. 4.

What should be included in Medical Device Clinical Evaluation Report?

  • In-house Procedure
  • Scoping
  • SOP for Stages of Evaluation
  • CER Plan
  • Declaration of Interest (LO Inc. must organize as per our guidance)
  • CV of the Evaluator (LO Inc. must organize)
  • Identification of Pertinent Data
  • Identification of Pertinent Data
  • SOP for Literature Search and Review
  • Search Results
  • Search Report
  • SOP for Demonstration of Equivalence
  • Demonstration of Equivalent Devices
  • SOP for Appraisal of Data
  • Data Suitability Appraisal
  • Appraisal of Criteria for Data Contribution
  • SOP for Analysis of the Data
  • Analysis of Data
  • Risk Analysis procedure + Risk Management File
  • Post Market Surveillance (PMS)procedure + Records Templets + PMS Plan templets
  • PMS records
  • PMCF procedure + Records Templets
  • Post Market Clinical Follow up records
  • IFU
When should the Clinical Evaluation Report prepared and how often does it need to be updated?

In Clause 6.2, Clinical Evaluation is a process that must be carried out throughout the life-time for the Medical Device.

In all cases the CER Report has to be completed during the pre-market phase, to support the demonstration of safety and performance of the medical device before placing it on the market followed by Report, which must be actively updated in order to demonstrate the continuous safety and performance of the device.

The Report need to be updated at least annually for Class 11b & Class III high risk or case of new devices. In other cases every 2 years.

Should manufacturers need to demonstrate qualifications of evaluators?

The person or team creating the report (CER authors and evaluators) must be properly qualified and evidences must be documented.

MEDDEV 2.7/1 Revision 4 requires that each evaluator should fulfil "Statement of Interest" and must also have a higher education degree with 5 years' experience in similar field of the device in question or 10 years of experience, if the degree is not required. Deviations from these requirements have to be duly justified and documented.

Benefits of using our services:

We support small, medium and large organization. No matter which type of organizations and customer locations.

  • We are dedicated and experienced team of 26+ consultants, biomedical engineers and medical writers working from Germany, India & USA.
  • Strong experience in various type of devices Class I, Class Is, Class Im, Class IIa, Class IIb & Class III Medical Device
  • Documents are developed in cloud so that the clients can view and comment at any point of time anywhere from the world.
  • Economic & Fast (Normally projects are completed within 60-90 days)
  • Projects will be handed-over after Notified Body’s approval (We never leave you in dark)
  • Friendly consultants.
  • Payments will be based on progress.
  • Access to various publications, large data bases of human usage evidences for various medical devices.
  • High quality and detailed inhouse developed procedures, protocols, templets which are modified several times as per comments from multiple Notified Bodies.
  • Strong Post Market Surveillance and PMCF documents which is an essential for the successful completion of CER
  • We develop high quality Risk Management File along with Clinical Evaluation Report which is very much essential for the successful completion of Report and annual updation.
  • Help manufacturers with Vigilance and product complaint data.
  • In-house and associated Medical practitioners / physicians and surgeons to oversee & guide on critical requirements on end-to-end deliverables

If you need more information on Medical Device Clinical Evaluation Report as per Meddev 2.7/1 Rev 4, please write to enquiry@i3cglobal.com. Our team will understand more about your device and guide you accordingly.

Resources about Medical Device Clinical Evaluation Report



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