A Clinical Evaluation Report (CER) records the determinations of a clinical evaluation of your medical device. A CER comprises of examined clinical data that was gathered either from a clinical investigation of your device, or the aftereffects of different investigations on significantly equivalent devices. The CER shows that your device accomplishes its expected reason without uncovering clients and patients to additionally chance.
Clinical Evaluation Report is required for all medical devices in Europe. You should present your CER to your Notified Body as a connection to your European CE Technical File. The Technical File is a basic advance to acquiring CE Marking for your device, which is needed to sell or disperse medical devices in Europe.
Medical device manufacturers need to evaluate clinical data from their own medical device or an equivalent device, whose security and clinical execution is the same. Under the MDR, the medical device manufacturer needs to consider three elements to demonstrate an item is identical: biological, technical and clinical.
The MDR places great accentuation on Clinical Evaluation Reports or CERs. The Clinical Evaluation Report shapes part of the Technical File, which is the primary documentation which exhibits regulatory compliance and gives all the information about the device. Medical device organizations need to take a few measures to ensure that their CER is solid and steady and very much kept up. Clinical Evaluation Report documentation ordinarily includes 4 phases:
- Defining the extent of the device, its intended usage and therapeutic / diagnostic claims.
- Identifying and validating clinical data.
- Analyzing the data and interpreting it to check whether it meets all the necessities.
- Identifying risks and uncertainties, this might be replied during post-market surveillance (PMS).
Clinical Evaluation Report for Medical Device
A Clinical Evaluation Report (CER) for Medical Device is a document that contains the finishes of the clinical evaluation performed on the medical device dependent on all important clinical data accessible.
The CER and the clinical data are utilized together to demonstrate the similarity of the medical device to the general safety and execution necessities. The CER incorporates the details of the clinical foundation, current information, and best in class which can be utilized to assess the security and execution of the device for comparing to its expected reason.
If a settled CE marked device which is like the device under evaluation, at that point the reports of that device can be utilized to demonstrate the security and execution of the device under evaluation by asserting equivalency, given an agreement is set up between the two manufacturers. Details of the post-market activities directed are additionally given in the CER, which is utilized to address any unanswered inquiries or residual risks that are not secured by the accessible clinical data.
Also, the aftereffects of the various tests directed are listed to demonstrate the wellbeing and execution of the gadget. During the investigation of the appraised information, the prerequisites on security, execution, agreeableness of advantage/hazard profile, and symptoms are surveyed to set up adjustment to GSPR.
The conclusion of CER includes the acceptability of the risk-benefit profile according to current knowledge/ the state of the art in the medical fields concerned and according to available medical alternatives. It also includes the adequacy of the information materials supplied, whether the intended purpose and risk reduction measures are adequate and any discrepancies.
Summary of the suitability of the device, including its IFU, for the intended users and usability aspects, any discrepancies are also included along with the adequacy of claims and its discrepancies. If there is consistency between the clinical data, the information materials, the risk management documentation for the device under evaluation; discrepancies should be summarized. The CER is used to ultimately evaluate and prove the device is safe for use on humans and that it performs as expected when used according to the manufacturer’s instructions.
Also, the CER shows that the presence of the device on the market is justified because of side-effects and risks, if any, are outweighed by the benefits of the device.
Device under Clinical Evaluation
The device under evaluation section is intended to describe the device, yet additionally depict the techniques utilized for the CER and the data investigation. It ought to incorporate a few segments, including a reason for the clinical evaluation, a showing for equality (if pertinent), and the clinical informational indexes utilized. This segment must address whether the clinical evaluation depends on logical writing and legitimize proportionality if clinical information isn\’t proper for the device.
Type of evaluation
Demonstration of equivalence
Data generated and held by the manufacturer
– Post-market surveillance
– Post-market clinical follow up
– Relevant Pre-clinical studies
– Biocompatibility testing (biological and clinical equivalence)
– Bench testing (technical and clinical equivalence)
– Electrical safety
– Software verification and validation
Data retrieved from literature
Summary and appraisal of clinical data
Analysis of the clinical data
– Requirement on Safety
– Requirement on acceptable benefit/risk profile
– Requirement on Performance
– Requirement on the acceptability of undesirable side-effects
Preparing a clinical evaluation report (CER) is time-consuming, but the report is also a living document. Therefore, you need to have 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..
