Why Clinical Evaluation Reports (CERs) are Challenging and How Celegence Can Streamline the Process

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device Regulation (EU MDR) is mandatory. These reports serve as documented evidence to establish that a medical device meets the required safety and performance standards.

However, for many manufacturers, preparing and maintaining CERs can be a daunting task. From navigating ever-evolving regulatory requirements to conducting rigorous literature reviews, the process of creating a CER is resource-intensive and often overwhelming. In this blog, we explore why CERs present such significant challenges to medical device companies and how Celegence can help streamline the process with expert consulting services and innovative solutions.

One of the biggest challenges in creating CERs is staying up-to-date with the ever-changing regulatory landscape. Different markets have specific regulations, and these go through updates quite often, which add additional complexity to the process. For instance, with the introduction of the EU MDR, the requirements for clinical data have become more stringent, making it difficult for manufacturers to maintain compliance without constant regulatory vigilance and post market surveillance (PMS).

It is the expectation that manufacturers need to continuously monitor any updates to the regulations that are applicable to their devices, any guidance documents that may have to be referred to, and expectations from the Notified Bodies based on previous review experiences. As stated earlier, the EU MDR has heightened the requirements for robust and relevant clinical evidence, particularly for higher-risk devices. There is an increased demand and expectation for post-market clinical follow-ups (PMCF) and systematic evaluations of clinical data, which adds an additional layer of complexity to an already complicated process.

The process of gathering sufficient clinical data for a CER is often one of the most challenging aspects for medical device manufacturers. Many devices, especially legacy devices, and low-risk devices, may lack the clinical data required by the current regulatory standards. Moreover, the collection of high-quality, robust, relevant, and up-to-date clinical data can be a time-consuming and costly endeavor.

Another critical component of CERs is the systematic literature review process. Conducting a comprehensive review that meets regulatory standards requires specialized skills and access to extensive databases. Even then, ensuring that the literature review is thorough and includes all relevant data points can be a significant hurdle. For medical devices that have been on the market for several years, as well as for low-risk devices, and devices used in conjunction with other medical devices, it can be especially difficult to find relevant studies or clinical and technical data that align with the product’s intended use and safety profile.

Creating a CER is not a one-time activity; it requires ongoing efforts to assess relevant clinical data, maintain compliance, update reports, and respond to regulatory body feedback. The process demands a combination of specialized knowledge in regulatory affairs, clinical research, and literature analysis, making it a resource-intensive process for manufacturers.

Furthermore, manufacturers must ensure that the content presented in their CERs are consistent across all documentation that are to be submitted to the Notified Bodies. This means, there is the expectation of close attention to detail, and frequent updates as and when new clinical data becomes available. The need for resources to perform these activities, whether internal or through outsourcing, can place a considerable burden on small to medium-sized manufacturers, who often lack the internal bandwidth to manage these tasks effectively.

The timeline to author and develop a CER depends on multiple factors; most essentially the risk classification of the devices, the amount of available data (both internal and external), whether the device is already established or new to the market, etc. Based on Celegence’s experience, the example depicted below presents a standard timeline that is required for developing a CER.

As per MEDDEV 2.7.1 Rev 4, clause 6.2.3, a CER is required to be updated at least annually for high-risk or newly established devices, and every 2 to 5 years for lower risk, well-established devices. This frequency also varies in the following scenarios:

• New information is received from the post market surveillance that has the potential to change the current evaluation process;
• Any updates to the design of the device or manufacturing process which impacts the safety and performance of the medical device;
• Any new risks identified from literature or other sources of data that affect the safety and performance of the device.

Based on the parameters stated above, the manufacturer must decide the frequency of update of the CERs.

At Celegence, we understand the complexities associated with navigating the regulatory landscape for medical devices. Our team of experts offer tailored consulting services to help medical device manufacturers meet regulatory requirements efficiently. Whether your organization is struggling with data collection, literature reviews, or regulatory submissions, our consultants can guide you and provide the expertise you need.

We specialize in helping clients comply with the most stringent requirements under EU MDR. By partnering with Celegence, you gain access to a team of regulatory professionals who stay up to date with the latest industry regulations and Notified Body expectations. This ensures that your CERs are not only compliant but also tailored to meet the specific needs of your medical device based on the risk classification and market.

One of the standout features of Celegence’s service offering is our AI-enabled systematic literature review solution. Traditional literature reviews are time-consuming and prone to human error. Our AI-powered tools streamline the data extraction process, enabling faster and more accurate reviews, while reducing the burden on your internal resources.

With Celegence’s technology, medical device manufacturers can focus on clinical data that truly matters. Our AI algorithms sift through thousands of documents to identify the most relevant studies and data points, ensuring a more efficient and thorough literature review. This ultimately helps speed up the CER development process, allowing companies to submit their reports faster and with greater confidence with respect to the accuracy and comprehensiveness of the data.

No two medical device manufacturers are the same, and neither are their regulatory needs. To address this individualistic requirement, Celegence offers tailored solutions which combat the unique challenges faced by our clients. Whether you need assistance with the entire CER process or just specific aspects like literature reviews or post-market clinical follow-ups (PMCF), Celegence provides flexible and scalable solutions that can be adapted to your needs.

In addition to providing regulatory consulting and literature review services, Celegence helps manufacturers reduce compliance costs over time. We work with your internal teams to optimize the CER development process, implement cost-effective solutions, and provide insights into how our AI-enabled software can further streamline compliance efforts.

Creating and maintaining compliant CERs is both challenging and resource-intensive, requiring manufacturers to balance stringent regulatory demands with efficiency. However, these hurdles can be overcome with the right expertise and tools.

Partnering with Celegence provides you access to skilled and experienced regulatory consultants, AI-driven solutions, and access to tailored support, to streamline your CER process. From navigating complex regulations to conducting systematic literature reviews, our specialists ensure your CERs are compliant with EU MDR requirements, enabling faster regulatory approvals and confident market entry.

Are you facing challenges with your Clinical Evaluation Reports? Contact Celegence today to learn how we can help you navigate the complexities of CER preparation and ensure regulatory success.