An Overview of the Clinical Evaluation Report
Also abbreviated as CER, a Clinical Evaluation Report is compulsory for all manufacturers who want to put their medical instruments in the European Union’s market. It is important to obtain your European CE technical file to get your CER.
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. Manufacturers should approach the CER as a standalone document. The CER comprises various elements, which makes it easy for the Union to approve your medical device.
MDR’s will consider the overall data quality 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 be updated 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 experimental 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.
The Medical Device Coordination Group (MDCG) released a guidance document in July 2020. The key requirements, along with the format of the Clinical Evaluation Assessment Report (CEAR), have been recorded by Notified Bodies (NBs) as part of their conformity analysis processes.
The MDCG, via the CEAR, aims to regulate the evaluation of manufacturers’ clinical evaluation by the NB.
Post assessment inferences of clinical evidence furnished by the manufacturer in the CER must be articulated by NBs via this document. Moreover, the clinical evaluation procedure executed should also be articulated by 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 manufacturer, when submitting the clinical evidence, should be able to define the below-mentioned objectives.
- Assess whether the data obtained from devices is ideal or not; while considering aspects like evolving symptoms and innovations.
NB and its Functions:
Inferences and relevancy of the data obtained from evaluations should comply with the rules and regulations formulated by the NB.
With the help of clinical data, pre-clinical data, and risk assessment, the NBs should evaluate the originality of the manufacturer’s claims. For instance, it is the responsibility of the NBs to ascertain the new indications or innovative features of medical devices.
- Confirm the suitability of the clinical proof, clinical assessment, and conclusions. This all will have to be prepared by the medical devices’ manufacturer by complying with the pertinent general safety and requirements related to performance.
Roles 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.
- It is the responsibility of the NB to assess user training; user instructions and the surveillance plan of the manufacturer are compliant with the latest rules.
- NB’s must also analyze the requirement and suitability of the proposed PMCF plan in functional areas.
- The NB also has to consider the results of the clinical examination and benefit-risk determination. It can recommend the possible definition of clear indicators to allow the NBs to assess updates emanating from PMCF and PMS data.
- CEARs will always recommend the final review. The NB will take this decision.
- CEARs will also support the particular additional requirements. From clinical examination consultation to the reviews from authorities, the CEARs support different requirements.
- While the fully completed CEAR report may not be enough proof of non-compliance, the NBs can utilize this document to record the irregularities. CEARs will record the results and inferences of the evaluation.
- The NBs are also liable for their analysis. Note that the authorities will have full access to the audit trail of the NB. The designated authorities have the full right to assess whether or not the NB executed the clinical evaluation assessment properly.
- Usually, the expert panels will have access to the CEAR. However, they are prohibited from accessing the full conformity assessment and device documentation. The CEAR must contain vital information like determinations based on benefits and risks and the evidence’s consistency.
For The Completion of Report Below Points Are Mandate
- All relevant units need to be complete, with conforming boxes marked, deducing appropriate conclusions.
- Complete all the indicated boxes only after closure of the entire non-compliances to depict the positive evaluation.
- Suppose more than one is open; minor non-compliances stay at the conclusion of the assessment. You will need accurate details and detailed elaborations in the template with ideal recommendations on the actions to culminate them appropriately.
- Need to follow the manufacturer’s stipulated completion deadlines under the regulation of the NB, which must be mentioned in CEAR.
- The sources of data evaluated should comprise –
- The report of the clinical evaluation
- The plan related to clinical investigation
- Report of clinical investigation
- Approval of the ethics committee
- Approval of the competent authority
- Data based on post-market surveillance
- Relevant publications.
- Based on the risk management of the manufacturers and consideration of the data derived from the interaction between the human body and the medical device and the manufacturer’s claims, the clinical performance should happen. Moreover, the clinical data summary should be present and provide clear insights into the benefits of using a medical device.
- An integral element of the CEAR is the examination of quantitative and qualitative factors of clinical safety. A suitable assessment is required by calculating the risks and side effects. The examination of quantitative and qualitative factors should also illustrate the compliance with proper safety and performance parameters.
- It is important to ascertain the rationale and source of equivalence. The assessment must show which devices are equal and possess minimal risks in the medical environment. The data associated with devices that are not equal should be kept out from clinical data assessment to showcase performance.
CiteMed: Thoughts on CEAR’s:
The introduction of EU MDR will implement stringent requirements for medical device manufacturers. The deployment of EU MDR will allow governing bodies to leverage the management of risks and post-market clinical assessment. Furthermore, it will also ensure conformity to the evolving specifications across the lifecycle of the device. That’s why a concise and extensive template to prepare documentation of the clinical evaluation will assist in easing the pressure on NBs.
This will also help the manufacturers to recognize and focus on the important elements which affect the Clinical Evaluation process. Hence, clinical evaluation is now an integral component of the quality control process of the manufacturers. Instructions for users along with PMCF and PMS should comply with clinical evaluation.
The primary purpose is to calculate whether or not the risks are acceptable when compared with the benefits. An important inference related to clinical evaluation is validation and demonstration of the capabilities of the medical device.