What is a clinical evaluation report?
Clinical Evaluation Reports are a must for all medical devices in Europe. They must submit your CER to your Notified Body as an attachment to your European CE Technical File.
The Technical File is an essential step to obtaining CE Marking for your device, which is necessary to sell or distribute medical devices.
CER shows that your device achieves its intended purpose without exposing users and patients to further risk without exposing you to further risks.
Submit the report as a follow-up to an EU Clinical Evaluation technical file. Within six months of the European licensing process, it must be submitted to obtain the Marking of any medical device to sell your device or distribute it in the EU market.
Required updates to your clinical evaluation report
Europe’s new Medical Device Regulation (MDR) will impose even stricter requirements for Clinical Evaluation Reports. MDRs will impose stricter requirements, such as the basis of.
Establishing an equivalence with another device. MDR’s will consider the quality of data in your clinical evaluation in the final analysis.
Failure to update your CER could jeopardize your conformity with the Medical Devices Directive.
Failure to do so could jeopardize your compliance with the new regulations, say European authorities.
Requirements and aims of the clinical evaluation
A medical device must be safe and perform well in clinical use in its use. After placing on the market, must update the evaluation through continuous monitoring of clinical performance and safety.
It is required to update the clinical evaluation, which can also update to comply with MDCG 2020-5 and 2020-6 requirements from ISO 14155.
According to risk management experts, the evaluation justifies certain measures within risk management, and therefore it is an essential part of the risk management process.
Manufacturers must reevaluate the product through technical adaptations and optimization of the product. Manufacturers must also consider Data from the product’s post-market surveillance of the own product and data from the observed product group.
MDCG Guidance Structure
The MDCG has provided additional clarifications on how the manufacturer should use the guidance document. However, the final guidance document exclusive to the clinical evaluation reports is still to be issued.
There is no requirement of including all information in the report – final results and conclusion would be sufficient.
The final report should also have information on any non-compliance identified during the assessment and the particular action taken by the medical device manufacturer to fix it, the advisory body states.
At the same time, everything included in the guidance could be subject to changes reflecting amendments to the applicable regulations.
The body also utilizes the concept of the minimum content – the lowest threshold of the information’s completeness and its applicability to the particular purpose.
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) documented by Notified Bodies (NBs) as a part of its conformity assessment procedures.
Through the CEAR, the MDCG aims to standardize the NBs’ assessment of manufacturers’ clinical evaluation and related documents.
Post assessment conclusions of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation procedure conducted must be clearly articulated by Notified Bodies (NBs) through this document.
How will the new European Medical Devices Regulation (MDR 2017/745) affect the industry
MDR 2017/745 and revised CER guidance released. Both documents reflect more stringent requirements for clinical data. The three-year transition period to the MDR will be three years before MDR becomes applicable.
The new regulations will be made effective in mid-2021. For more info on MDR or the new CER regulations, visit the European Health Agency’s website.
UK and more details about the new regulations and how MDR is to be implemented in Europe.
Notified Body Clinical Evaluation Assessment Reports:
The clinical evidence presented by the manufacturer should address the following objectives:
- Evaluate whether the data from claimed equivalent devices is suitable or not; while considering factors such as new indications and innovations.
Functions of the NB:
Conclusions on the claimed equivalence and the relevance and adequacy of the data to demonstrate the NB must clearly document conformity.
Through pre-clinical and clinical data and risk analysis, the NBs must assess the extent of specific claims, if any feature has been claimed as innovative, or if the device has new indications.
- Verify the adequacy of the clinical evidence, clinical evaluation, and conclusions. This all will have to be prepared by the manufacturer in conformity with the relevant general safety and performance requirements.
Functions of the NB:
The NB should evaluate if the benefit-risk determination, risk management, instructions for use, user training, and the manufacturers’ post-market surveillance plan are sufficient.
The NB’smust also review the need for and adequacy of the PMCF plan proposed, wherever applicable.
- Last but not least. The clinical evaluation and the benefit-risk determination need to consider. It can recommend the possible definition of specific milestones to enable the NBs to review updates to the clinical evidence from PMS and PMCF data.
- CEARs will make a recommendation to support a final review. The NB will take this decision.
- CEARs in this format will also support specific additional requirements. Such as the clinical evaluation consultation procedure and reviews by designating authorities.
- While the completed CEAR may not necessarily be a completely comprehensive record of the non-compliance/deficiencies, NBs may use this document to record the non-compliance/deficiencies and queries raised during the assessment and the assessment of responses received. CEARs will document the outcomes and conclusions of the assessment.
- NBs, too are responsible for their assessment. As designating authorities will have access to the complete “audit trail” of the NB. Designating authorities will, in turn, assess if the NB conducted the clinical evaluation assessment properly after consideration of the procedures, assessment, and associated documentation and conclusions.
- While expert panels conducting a clinical evaluation consultation procedure will assess the CEAR, they may not have access to the complete conformity assessment, related procedures, and documentation for the device. Hence, the design of CEAR is to provide adequate information about the clinical evidence provided by the manufacturer. The CEAR shall contain essential information such as benefit-risk determinations, the consistency of that evidence with the intended purpose, including the indications for use and the PMCF.
For The Completion of Report Below Points Are Mandate
- All pertinent sections need to be complete, with corresponding boxes ticked, arriving at relevant conclusions.
- Complete all tick boxes only after closure of all the non-compliances to indicate a positive assessment.
- Suppose one or more open, minor non-compliances remain at the end of the assessment. Need proper details in the template with suitable suggestions on follow-up actions to close them out adequately.
- Need to follow the manufacturer’s expected corresponding completion timelines under the supervision of the notified body and must specify in the CEAR.
- The data sources assessed would include –
- The clinical evaluation report
- Clinical investigation plan
- Clinical investigation report
- Ethics committee approval
- Competent Authority approval
- Post-market surveillance data
- And relevant publications.
- According to the manufacturers’ risk management and consideration of the specifics of the interaction between the device and the human body, the clinical performance intended, and the claims of the manufacturer, an assessment of clinical performance must take place. Here a summary of the clinical data, which demonstrates the ability of the device to achieve its intended purpose according to the manufacturer, must be present and should provide a description of the clinical benefits.
- A vital component of the CEAR is the assessment of the qualitative and quantitative aspects of clinical safety. A proper assessment is needed by determining residual risks and undesirable side effects and confirming compliance with relevant safety and performance requirements.
- One must establish the source and rationale for Equivalence. For instance, according to clinical investigations, if equivalence is shown or other studies reported in the scientific literature; The assessment must indicate which devices are equivalent or not. And confirm that data relating to devices that are not equivalent are keeping out from the analysis of clinical data to demonstrate safety and performance.
CiteMed: Thoughts on CEAR’s:
The implementation of the EU MDR will bring in stricter PMS requirements. It can cause laying more emphasis on risk management, post-market clinical evaluation, and ensuring conformity to new specifications through the device lifecycle.
Thus, a clear, comprehensive template for the documentation of the Clinical evaluation assessment will not only help ease the ever-increasing burden for NBs with audits, timelines, and assessment guidelines.
But will also help manufacturers identify and focus on the crucial elements that critically impact the Clinical Evaluation Assessment.
Therefore, Clinical evaluation is now a critical component of the manufacturer’s quality management process. The PMS, PMCF, and Instructions for use should align with the clinical evaluation.
This is to determine whether the risks are acceptable when weighed against the expected benefits. Thereby eliciting any corrective and preventive actions involving the device.
The key takeaway concerning clinical evaluation for manufacturers and NBs; is a demonstration and validation, respectively, of intended clinical benefits to patients, with relevant and specified clinical outcome parameters.
At the same time, adhering to general performance and safety requirements with minimal residual risks.