If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical Evaluation Report. However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER). Subsequent posts will feature information on your planning document (the Clinical Evaluation Plan or CEP), conducting systematic literature searches and reviews, post market clinical follow-up (PMCF), and the summary of safety and clinical performance (SSCP). Let’s get started.
CERs are not new under the EU MDR; they existed under the MDD (Medical Device Directive). In June 2016, MEDDEV 2.7.1 was updated to Revision 4. This updated guidance was the first glimpse of what the changing landscape would look like for CERs. The days of running an updated literature search and analyzing for only new or different adverse events are long gone, as analysis of the clinical literature has now placed important focus on safety and performance outcomes as compared to state of the art (SOTA) devices. Moreover, under MDD, a company would be able to show biological, clinical, and technical characteristics between the similar and subject devices and draw equivalence comparisons based upon materials, indications for use, and design. This level of equivalence allowed a company to provide clinical data from similar devices from different manufacturers to support the safety and performance of the subject device.
Claiming equivalence under the EU MDR is much more stringent and requires not only the robust comparison for biological, clinical, and technical characteristics, but also a legal contract to be able to use the clinical data. Very simply, if the manufacturer doesn’t have legal rights to the similar device upon which to claim equivalence, they will need to obtain the legal right to use any clinical data.
A CER under EU MDR is now much more comprehensive and objective, comprising of a series of documents that pull information from many different areas such as clinical, risk management, and post-market surveillance. The Clinical Evaluation Report or CER is a living document with required scheduled updates usually driven by the Periodic Safety Update Report (PSUR), which is dependent upon the EU classification of the device. The higher the classification, the more frequent updates are required.
The CER process begins with a planning document, appropriately termed Clinical Evaluation Plan, or CEP. Planning is vital to the CER to ensure you define the proper scope and obtain the correct data. Considerations include:
This list of questions and considerations isn’t all inclusive but is a good starting place to determine the clinical data you have from existing sources and the clinical data you may need to acquire.
Clinical data is the crux of the CER. As the name implies, the CER evaluates and analyzes all the relevant clinical data pertinent to your device. The ultimate goal is to show that the benefits of your device outweigh any risks associated with your device performed through performance and safety outcome comparisons, which also maintains its state of the art status. Clinical data can be obtained from a clinical trial that the company conducted with the device or may be gleaned from published clinical literature. Clinical data for similar devices cannot be used to support the subject device unless you can claim equivalence. The terminology for similar device and equivalent device is not interchangeable. Capturing on-going clinical data is also achieved through Post-Market Clinical Follow-up (PMCF). We’ll address the specifics of PMCF in a future blog post in this series.
State of the Art focuses on similar devices and benchmarking development. Similar devices share the same intended and/or indications for use, materials, critical design features, patient populations, and users. The clinical data established for similar devices sets the foundation for the benchmarks that your device must meet. Identification and development of the correct benchmarks is critical to the CER, as the benchmarks are the performance and safety acceptance criteria that is set for the specific device and supported robustly by the published literature. Note that some devices are supported by common specifications, but the vast majority of devices do not fall into this scenario.
So, what is the right approach to take for gathering data, developing evidence, and generating the CER overall? The good news is that you don’t have to pick a single solution or approach every CER in the same way. The strategy that makes the most sense for one device or device family may differ from another device. As mentioned above, the class of device and areas of consideration will drive your strategy during the planning stage.
A few tips and takeaways are to:
In conclusion, take the time to plan and assess any gaps in your data. Knowing what data you have and what you need will provide a sound basis for your strategy and enable the best possible Clinical Evaluation Report.
Navigating the complexities of EU MDR and developing a robust Clinical Evaluation Report can be challenging. ProPharma’s experienced team of regulatory experts is here to help you every step of the way. From planning and data analysis to submission, we ensure your CER meets the highest standards of compliance and safety. Contact us today to learn how we can support your medical device's success in the EU market.