One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that demonstrates the safety, performance, and efficacy of your device.
What is a CER?
CER is a report of the assessment and analysis of a medical device’s clinical data which is typically collected to verify the performance and safety of the device. A CER is a live document that is created, using published literature, clinical studies, etc., for the first time before regulatory approval is obtained for a medical device, and is consistently updated post this approval with additional post-market and other relevant data which is obtained for the device throughout the lifecycle of the medical device. Creating a CER is a complex, time-consuming, and resource-extensive task irrespective of the device classification or how well-established the company is.
Why is a CER needed?
A CER is a much-needed element not just for a regulatory submission but also for post-approval compliance. It is the responsibility of the manufacturer to include a CER in the technical documentation of the device. Depending on the classification of your device, the extent and precise content of the clinical evaluation can be determined.
What kind of information should be included in a CER?
The information that goes in a CER is governed by the regulatory requirements, risk classification of the device, MEDDEV 2.7/1 Revision 4, and well-appraised data which may be obtained from the published literature, retrospective or prospective clinical studies performed for the subject or equivalent devices, or from any other relevant investigations or testing.
What are the general steps involved in a CER?
A Clinical Evaluation Report involves the following steps in general:
- Create a detailed Clinical Evaluation Plan (CEP) for the activities to be conducted
- Procure the right literature to demonstrate the safety and performance of similar devices
- Undertake the review and evaluate the results in an objective and scientific way
- Collect clinical data in an organized manner and appraise the data found
- Draft a detailed CER based on the literature review
What are the Stages that a CER undergoes?
A Clinical Evaluation Report should be well-structured and precisely drafted to ensure that the report demonstrates that the technology used in the device is well-established and reliable. While the specifics of an effective report differ depending on the class of device, the layout of an effective CER remains the same. In order to have a CER that presents a robust and objective scientific analysis of clinical evidence should undergo the following major stages:
Stage 0 – Identification of Scope
A clear understanding of the intended use, classification, and technological characteristics of the subject device is crucial. Determining whether the device requires a literature route or a clinical route or a combination of both to perform a clinical evaluation is also important. The scope of the evaluation has to be clarified and clearly laid out in the Clinical Evaluation Plan. A CEP should provide an identification of the general safety and performance requirements that require support from clinical data, which shall be subsequently addressed in the CER. Considerations for the scope of CER and other details for constructing a CEP generally vary depending on the level of the product’s lifecycle.
Stage 1 – Identifying Pertinent Data
The data may include the clinical data from pre-market clinical investigations, PMS reports, details of field safety corrective action, and many more, depending on whether the CER is a new CER or an update. It is important that a CER is in line with the CEP; after determining the keywords and inclusion and exclusion criteria in the CEP, the relevant literature must be collected and summarised. The summarized literature must demonstrate the safety and efficacy of the device and/or the technology used. In addition to this, information or relevant data on the etiology of diseases, current knowledge, and state of art, must be provided.
Stage 2 – Appraising the data
Here, the data obtained is appraised in terms of relevance, applicability, quality, and significance. The clinical data collected from the literature review must be appraised considering various parameters that help quantify the significance and relevance of that data. This includes the criteria for inclusion of the relevant data in clinical evaluation such as device type, study type, study size, and the statistical significance of the data. It is important to ensure that all the finalized data/literature results demonstrate the safety and performance of the device in question.
Stage 3 – Analysis of Clinical Data
Discussions on the summarised scientific literature with respect to the subject device should be provided in the CER. This stage focuses on articulating the conclusion of whether a further clinical evaluation is required and determining the PMCF needs. Additionally, the gaps and discrepancies are identified and summarized with a risk-benefit profile in perspective.
Common Pitfalls of a CER
- Choosing the wrong time to start
Manufacturers should have evidence preparedness before starting to draft a CER. This evidence includes holding the details of pre-clinical bench tests, clinical evidence, and PMS data, as applicable. Additionally, an experienced eye on regulatory framework is also essential. So it is better to wait until the right time!
- Failing to follow the MDR requirements
CER needs to be updated with the latest requirements and MDCG guidelines. While following MEDDEV 2.7/1 rev 4 is acceptable, it is also critical to check for the latest requirements before drafting a CER.
- Lack of strategy for literature search
The literature review is the most cumbersome of all the processes of CER drafting. However, having a sturdy CEP and the right strategy can accelerate the time to completion.
- Unsubstantiated language and data
It is of essence to draft a CER in the third person, especially to avoid the inclusion of irrelevant and unsubstantiated data in CERs which can inevitably lead to non-conformities.
Importance of a strong team to draft a CER
A company may sometimes operate on the misconception that CERs are a one-off task. However, CER is a resource-extensive task and the work associated with it is not over after the initial approval. It needs to be updated annually based on the data from Post Market Surveillance or at least every two to five years for low-risk devices. A large percentage of manufacturers do not understand MDR sufficiently and do not have a strategy in place to correct gaps in their clinical data, nor do they have a process in place to collect the data required. Elexes, having experienced CER writers who integrate complex regulatory requirements with the device’s specific characteristics and present the information clearly can help companies save time and money.
Demystify your worries on CER formulation!
For any ambiguity in a Clinical Evaluation process, a company can contact us at email@example.com, we will be happy to assist you!
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