Clinical Evaluation Report as per Meddev 2.7/1

Clinical Evaluation Report (CER) as per MEDDEV 2.7/1 Rev 4 is considered a tool to provide Notified Bodies with a complete overview of the continuous clinical evidence of safety and performance of the medical device. During the clinical evaluation process, all data that could provide information on the clinical safety and performance of the device is analyzed and assessed.

Due to this reason developing and maintaining Medical Device CER Reports became a higher priority for CE Marked Medical Device manufacturers across the globe

A good CER Report should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The report must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical 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 Clinical Evaluation Report by Notified Bodies.

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

What should be included in the Meddev 2.7/1 Rev 4 Clinical Evaluation Report?

  • Clinical Evaluation Procedure
  • Scoping
  • SOP for Stages of Clinical Evaluation
  • Clinical Evaluation 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 Clinical Data
  • Data Suitability Appraisal
  • Appraisal of Criteria for Data Contribution             
  • SOP for Analysis of the Clinical Data
  • Analysis of Clinical Data      
  • Clinical Evaluation Report with below supporting evidences
  • Risk Analysis procedure + Risk Management File
  • Post Market Surveillance (PMS) procedure + Records Templets + PMS Plan templets
  • PMS records
  • Post Market Clinical Follow (PMCF) procedure + Records Templets
  • PMCF records
  • IFU            

When a Clinical Evaluation Report (CER) have to be 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 of the Medical Device. In all cases the Clinical Evaluation Report has to be completed during the pre-market phase, to support the demonstration of safety and performance of the device before placing it on the market followed by Clinical Evaluation Report 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 & III high risk or case of new devices. In other cases yearly every 2 years.

Should manufacturer need to demonstrate qualifications of evaluators?

The person or team conducting 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 fulfills a "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 Clinical Evaluation Report service:

We support small, Medium and large organization. No matter the type of organization and the customer location.

  • 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/m, Class IIa, Class IIb & Class III)
  • Documents developed in cloud so clients can view and comment at any point of time anywhere from the world.
  • Economic & Fast (Normally projects completed in 60-90 days)
  • Project Handover after Notified Body approval (We newer leave you in dark)
  • Friendly consultants.
  • Payment based on progress.
  • Access to various clinical evaluation publications, large data bases of clinical 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 Post Market Clinical Follow up documents which is an essential for the successful completion of Clinical Evaluation Report
  • High quality Risk Management File we develop along with Clinical Evaluation Report, is very much essential for the successful completion of Clinical Evaluation Report and annual Clinical Evaluation Report updation.
  • Help manufacturers with Vigilance and product complaint data.
  • Inhouse and associated Medical practitioners / physicians and surgeons to oversee & guide on critical requirements on end to end deliverables

Some of the questions answers you can find from the below useful links.

Clinical Evaluation documentation fees as per Meddev 2.7/1 Rev 4 (Click here>>)
Existing Medical Device Clinical Evaluation Report GAP analysis (Click here>>>)
Download an useful article about Medical Device Clinical Evaluation Report (Click here>>)

If you need more information about Medical Device CE Marking Clinical Evaluation Report(s) as per Meddev2.7/1 Rev 4, please write to Our team will understand more about your device and guide you accordingly.

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+ 91 994 591 2081
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