Clinical Evaluation Assessment Report
What your Notified Body wants to see in the CEAR
A Clinical Evaluation Assessment Report (CEAR) is a comprehensive document that provides an in-depth analysis of a medical device’s clinical data and its ongoing safety and performance. It is a crucial component of the regulatory process for medical devices, particularly in the context of the European Union Medical Device Regulation (EU MDR).
It’s required for all manufacturers who want to sell medical instruments in the European Union. You must first obtain your European CE technical file to earn your CEAR. The Technical File is a critical step in acquiring CE marking for your product, which must be sold or distributed. CEAR demonstrates that your product accomplishes its intended purpose without endangering users or patients, and the manufacturer’s reputation or financial prospects.
The CEAR is being filed as a follow-up to a technical file evaluation by the European Union. You must be able to submit it within six months following the European licensing process to receive the CE marking of any medical device to sell or distribute it in the EU market.
How will the new European Medical Devices Regulation MDR 2017/745 affect the industry?
Stricter standards for clinical data are reflected in MDR 2017/745 and amended MDCG CEAR advice. Clinical evaluation is a critical component of the technical documentation required for regulatory compliance of medical devices sold in the European Union (EU). Therefore, having a well-designed and clearly written clinical evaluation assessment report is critical for both existing and new medical device manufacturers. EU MDR requires enhanced clinical evidence to support the device, whether you have Class I or Class III products.
Update Requirements for your CEAR's
The CEAR is a document that documents a device’s whole clinical evaluation process and is required for EU marketing compliance. Essentially, the CEAR summarises the evaluation and clinical data used to determine if the evidence satisfactorily confirms the medical device’s clinical safety and performance. Manufacturers must regularly update the CEAR as a living document during the life cycle of the device.
Under Europe’s new Medical Device Regulation, they will hold clinical evaluation assessment reports to far higher standards (MDR). Manufacturers should treat the CEAR as a stand-alone document. MDRs will consider the full data quality in your clinical evaluation in the end. The CEAR consists of numerous parts that help the European Union approve your medical product quickly. According to European authorities, your compliance could be jeopardised if you don’t keep your CEAR up to date.
Clinical Evaluation Requirements and Goals
A medical device must fulfil its intended purpose, while being safe and performing well in its indicated use. Following the launch of the product, the evaluation must be updated through ongoing clinical performance and safety monitoring. The clinical evaluation must be updated, and it can also be changed to meet the MDCG 2020-5 and 2020-6 requirements from ISO 14155. According to risk management experts, the evaluation supports specific risk management actions and is therefore an important aspect of the risk management process. Manufacturers must reassess the product by making technological adjustments and optimising it. Manufacturers must consider data from the product’s post-market surveillance, as well as data from the experimental product group.
Systematic Literature Reviews (SLRs), are a fundamental part of the clinical evaluation process. They involve a structured and systematic approach to identifying, analyzing, and summarizing all relevant published literature on a specific medical device or a related clinical topic. SLRs help establish a comprehensive understanding of the existing body of evidence, which is essential for informed decision-making during the clinical evaluation process.
In essence, a CEAR relies on the findings and insights derived from systematic literature reviews to form a robust assessment of a medical device’s clinical performance. These reviews serve as a critical source of data and information, helping regulatory authorities, manufacturers, and healthcare professionals make well-informed decisions regarding the device’s safety and effectiveness.
What can the MDCG Guidance tell you?
The MDCG has offered additional explanations on how the maker should use the advice paper. The final guidance paper, applicable only to clinical evaluation assessment reports, has yet to be released. Currently, MEDDEV 2.7.1 rev4 still applies, and the European Union has issued no templates for the CEAR. It is unnecessary to include every section in the report. However, the final results and conclusion would be comprehensive enough to justify your benefit to risk assessment and how you meet the GSPR for the SoTA.
According to the advisory board, the final report should include information on any non-compliance discovered during the assessment and the specific action taken by the medical device manufacturer to correct it. Simultaneously, everything in the guidance could be subject to change due to changes to the applicable regulations. The body also employs the concept of minimum content, which is the lowest level of completeness and usefulness of information to a specific purpose.
In July 2020, the Medical Device Coordination Group (MDCG) issued a guidance document. Notified Bodies (NBs) have recorded the major requirements, as well as the format of the Clinical Evaluation Assessment Report (CEAR), as part of their compliance analysis processes. The MDCG, through the CEAR, strives to govern the NB’s clinical review of manufacturers’ products. NBs must articulate post-assessment judgments from clinical evidence provided by the manufacturer in the CER via this document. NBs should use this paper to clarify the clinical evaluation procedure they used.
What to Expect from the Notified Body Clinical Evaluation Assessment Reports
The manufacturer should be able to define the General Safety and Performance of the device against the State of the Art. Clarify whether the data collected from devices is ideal or not, while taking into account factors such as growing symptoms and innovations, in contrast to the EU guidance.
NB and its Functions
The NB’s rules and regulations should be followed while making inferences and using data received from evaluations. The NBs shall assess the originality of the manufacturer’s claims using clinical evidence, preclinical data, and risk assessment. The NBs, for example, are responsible for determining new indications or unique features of medical products. Confirm the clinical proof, clinical assessment, and conclusions are appropriate. All of this will have to be prepared by the medical device manufacturer in accordance with the relevant general safety and performance requirements.
Important Points
- CEARs always recommend the final evaluation. The NB will make this decision.
- CEARs will also support the new needs. The CEARs support various requirements, from clinical examination consultation to authority reviews.
- While a fully completed CEAR report may not be sufficient proof of non-compliance, NBs can use it to highlight any abnormalities. CEARs will keep track of the evaluation’s findings and conclusions.
- NBs are also responsible for their research. Authorities will have complete access to the NB’s audit trail. The designated authorities have complete authority to determine whether the NB completed the clinical evaluation assessment correctly.
The CEAR is usually accessible to the expert panels. They are however unable to view the full compliance evaluation and device paperwork. The CEAR must include critical information, such as conclusions based on benefits and risks, as well as the consistency of the evidence.
Critical Aspects
- Clinical performance should occur based on the manufacturers’ risk management and analysis of data produced from the interaction between the human body and the medical device, as well as the manufacturer’s claims. Furthermore, a clinical data summary should be available, providing clear insights into the advantages of employing a medical device.
- The study of quantitative and qualitative clinical safety aspects is an important part of the CEAR. Calculating the risks and side effects is necessary for a proper assessment. The analysis of quantitative and qualitative criteria should also show that suitable safety and performance parameters are being followed.
- It is critical to determine the rationale for equivalence as well as the source of equivalence. The evaluation must demonstrate which gadgets are comparable and pose minimal hazards in a medical setting. To demonstrate performance, data connected with devices that are not equal should be excluded from clinical data analysis.
A Clinical Evaluation Assessment Report and Systematic Literature Reviews are intertwined processes, with the latter serving as a foundational element in the compilation of comprehensive and evidence-based clinical evaluation reports for medical devices.
CLIN-r+ Recommendations
- Medical device producers will face stricter regulations because of the introduction of EU MDR. This does not only affect the Clinical Evaluation workflow. Getting experienced CEAR writers and consultants onboard early on not only improves the likelihood of a successful NB audit. But also saves resources and time that the manufacturer can focus on other areas. As the Clinical Evaluation is a key workflow that automatically audits your QMS system and highlights areas of concern, it’s the most efficient and cost-effective area to bring in experts. Experienced CEAR consultants will not only identify problems upstream, but also advise on solutions, best practices deployed by the medical device industry, and efficient workflows to overcome problems later on. Consultancies also come with resources such as systematic review software, access to literature databases, and industry expert reviewers, helping expand your companies’ capabilities cost-effectively.
- Consider partnering with a consultancy to maintain your CEAR. When you have certification, you still have more work to do. CLIN-r+ can update documents and create reports as new data arises—and periodically as required—so that you always comply. Investing in ongoing maintenance also helps streamline updates to risk management and SSCPs, and the creation of PSURs.
To learn more about CLIN-r+ services for medical devices and IVD manufacturers, get in touch!
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