Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school, you had to earn good grades and maintain a solid record to impress college admissions officers? Well, in the world of medical devices, there’s a similar report card of sorts that can make or break a product’s chances of hitting the market: the Clinical Evaluation Report CER. Think of it like a high school transcript, but instead of grades, it’s a comprehensive evaluation of a product’s safety and performance based on clinical data. And just like how you wouldn’t want to submit a lackluster transcript to your dream college, you definitely don’t want to submit a subpar CER to regulatory authorities. So, let’s dive into what exactly a Clinical Evaluation Report is all about!
What is a clinical evaluation?
As the name suggests, the CER is the report of clinical evaluation. What’s that? Let’s see.
The official definition of clinical evaluation is:
“a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for use.”
You pretty much get an overall summary from this definition. But here is a breakdown in simple everyday language.
- The clinical evaluation is an ongoing process. Meaning it’s a process, not a one-time thing. One of the most common mistakes we see our clients make is deciding to the CER at the last minute. You literally can’t write a CER if you do not have the data of the CE or clinical evaluation process! Plus, you will have to have a plan for doing the evaluation itself as part of the CER. So, really, the CER starts at the very beginning of the process.
- It’s methodologically sound. So, this process has to make sense: not just to you but also to the people reviewing it. You will need to make sure the data is collected how data is supposed to be collected. A definite method has to be followed, with exact parameters and other details.
- CER involves collecting, appraising, and analyzing clinical data. There is some background work you need to do on this. Before you start a clinical investigation to collect clinical data, you need to be sure you are collecting the “right” ones. The term clinical data is defined separately in the MDR, along with how much data you need and which sources you can use. However, as the term clinical is there, you can expect clinical data generated from human tests and trials. Although whether you have to do them or you can follow other substantially equivalent devices depends on your medical device and which classification it falls in. You also have the appraisal criteria, performance requirements, and risk class.
- You have to provide sufficient clinical evidence. This, like the clinical data, is a bit tricky. You will need to ensure you have provided the people reviewing your clinical evaluation report think it is enough at least. But you don’t have to take a completely blind guess! There are several guidance documents given by the EU to help you understand what they will be looking for.
- The safety and performance of the device are pretty much at the center of the clinical tests and data collection you will be doing.
- As the manufacturer, you will give the instructions for the use of the device. However, you will also choose the intended use or the desired effect the device should have. It goes without saying that the device should be able to reproduce the desired result each time, given the instructions were followed properly. Otherwise, it will all be for nothing!
- There are lots that aren’t mentioned in the definition as well. For example, you will need to do post market surveillance, risk management activities, and literature reviews as well.
The clinical evaluation report is simply a report on all the work you have been doing to ensure your device conformity to the medical device regulations set by the EU.
What is the importance of a clinical evaluation report?
CER’s importance is simply in its purpose. It is a technical file. You can’t get your medical device in the market without conforming to the EU standard, and the declaration of conformity is made through the CE marking, which you obtain after your CER report is approved.
It’s the ultimate tool for demonstrating a device’s suitability for use in a specific patient population or clinical setting and helps regulatory authorities to make informed decisions about its safety and efficacy.
Apart from this, you also learn a lot about your device from the CER process. Often, unseen and unexpected mistakes will come up during the process, and you will be able to correct them before placing the device on the market.
But the CER isn’t just for the regulatory bigwigs – it’s also a critical tool for professionals of clinical background who need to make informed decisions about the use of a medical device in their patients. After the CER process is done, you will have to upload parts of the research in the EUDAMED (it will be fully active soon). Doctors and other manufacturers can assess its potential benefits and risks from there.
Does the FDA require a clinical evaluation report?
Like any other regulatory organization, the FDA does require some paperwork on clinical data analysis. Unfortunately, the classification of devices and the requirements from the FDA and MDR aren’t exactly the same. So, you can’t submit the same report to both and call it a day.
What are the requirements of CER?
The requirements of the CER are quite a few. It’s a long report with many parts and divisions. Usually, the report follows the clinical evaluation plan. As per the MDR guidelines, a good clinical evaluation report has 4 parts or stages of clinical evaluation it must describe. These are:
- Stage 0, the scope of the clinical evaluation.
- Stage 1 is the identification of pertinent data.
- Stage 2 is the appraisal of pertinent data.
- Stage 3 is the analysis of the clinical data.
These stages will have all the data obtained during the clinical evaluation and sent to the notified body for approval.
Who Reads the CER?
A group of people selected by the EU who are qualified to check the CER report for regulatory compliance is in charge of reading the CER. They are called the Notified body. The notified body will conduct a conformity assessment of the medical device and decide whether the device conforms to the EU standard.