MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices

 

CER as per MEDDEV 2.7.1 Rev 4 - Why this is more complex now than before?  

A good Clinical Evaluation Reports should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.

The clinical evaluation report as per MEDDEV 2.7/1 Rev 4 should adress: any design features that pose special performance or safety concerns; the intended purpose and application of the device; and the specific claims made about the clinical performance and safety of the device. It is important to describe the merit and limitations of any data cited or included in the evaluation.

The manufacturer's risk assessment documentation is of very important to ensure that resudal risk after control meures addressed in it. The instructions for use (IFU) for the device are reviewed during the process to ensure that data is gathered from the same population using the device in the same way for the same indications, as described in the IFU. Finally, conclusions are drawn about whether the Essential Requirements relevant to clinical safety and performance are met.

What we do for CER Report? 

  • Literature Search Protocol .
  • Selection of Databases
  • Selection of Key Words .
  • Inclusion & Exclusion Criteria
  • Addressing Risks .
  • Review of Post-Market Surveillance
  • Appraisal of Clinical Literatures .
  • Review and Update of Clinical Evaluation Reports (CERs)
  • Developement of Procedures & Templates .

Review and Update of Clinical Evaluation Reports (CERs)
Preparing a clinical evaluation report (CER) is time consuming and requir deep passion and skil. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report.

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