If you have not yet completed the clinical evaluation procedure, you must be wondering how many resources you will need to complete it?
How you are going to complete CER within the stipulated time and according to updated EU MDR guidelines.
Here in this blog, we will discuss some techniques to prepare a CER report on time.
4 Stages to prepare CER report for medical device manufacturers
A CER is a detailed report of pre-market and post-market clinical data related to a medical device. An important factor is the continuous update of data throughout the life cycle of the product. Below are 4 different stages to perform a clinical evaluation of a medical device:
Stage 0: Scope and Plan
In this stage, the manufacturer has to explain the objective and structure of the clinical evaluation, classification of product development, and intended usage of the device.
Stage 1: Identification
Identifying and collecting clinical data, equivalence, possible sources, clinical investigation, academic literature, and clinical experience.
Stage 2: Assessment
Individual Data evaluation and assessment of data according to defined criteria such as:
- Is the source reliable?
- Does the source give information on product benefits and safety?
Stage 3: Analysis
Proper evaluation of relevant data to assess the performance and safety of the medical device is given. Analysis to be done on the below criteria:
- Significance of product data
- Conclusions on product safety and benefit
- Possible qualitative and quantitative evaluation
Stage 4: Finalize the Report
Finally, create a logically structured report on the evaluation including justifications and documentation of the steps. Also document all steps in the CER.
All the above stages are procedures that every manufacturer has to follow to create an effective report. Details of every report may vary according to the type of device manufactured but the architecture of the CER report is the same for all devices.
6 Basic Principals involved in creating an effective CER report
Summary
An effective CER report must summarize:
- Benefit or safety of the product
- Intended target groups
- Medical indications
Scope
The scope of the CER report must discuss the technical and clinical aspects of the devices. This should clearly explain how the device work and what are the technologies used in creating the device. The scope of the report may be lengthy or short depending upon the sophisticated technologies used behind the device.
Scope of any device should:
- Identify the devices including product size, model, accessories, and software version if applicable
- Name and address of the manufacturer
- Include the picture of the device
- Classify the device by group
- Provide the precise description of the device
- Describe any precautions if needed
- Address any changes to the device or major events since the last CER updated
Clinical Background
The clinical background of any device should be in details and address:
- Sources
- Search methods
- Quality control measures
- Results
- Number and type of research literature
- Selection criteria for the literature review.
- Explaining who would be using the device under clinical conditions
For some devices, this section may be quite short and to the point, and for devices, this section may be longer depending on the scope, benefit, and safety of the device.
Device Under Evaluation
This is the last section of the report that should include the following information:
- Evaluation Qualifications
- References of data sets
- A signed statement from the evaluator
- Date of the current CER
- Date of the next CER
- Final release date from the manufacturer
Bottom Line:
The complexity of the CER may vary but the outcome should be the same for all devices. The final report should be able to read and understand by a third party or a notified body. The length of the CER report may vary depending on various factors including the device being evaluated.
