If you want to revolutionise the medical equipment market and have an amazing device ready to change people’s lives, you have to go through the obstacles of getting it approved first. A CER (clinical evaluation report) is very important to get your medical device approved for use in any member nation of the EU. Without a properly produced CER, you can rest assured that your device will not be sold to the public. The level of detail of your CER will hugely vary with the complexity of your device. However, getting a CER made isn’t difficult, and you can easily get your device approved with a properly designed CER.
There are numerous other benefits to having a professionally made CER which is why we’re going to take a look at what exactly a CER is and the other advantages of this report. We’ll also be looking at how you can get a comprehensive and convincing CER made for your medical device so that your chances of approval are maximised. So, let’s get to it and clear all of your doubts about the CER.
What is CER?
A CER is used to document all the results from a clinical evaluation of medical devices. The data that a CER elaborates is gathered from the properly conducted clinical evaluations of your device. The results published in a CER don’t always need to be of your medical device, you can also include the results of other similar devices that already exist. The main goal of CER is to showcase the safety of your device for the end-users, this safety guarantee is taken rather seriously by the buyers as it comes directly from your end. If you wish to see your device being used inside Europe, you need to get a CER done which will help you obtain a CE marking, which is the European equivalent to the FDA approval. With the help of a CE marking, you’ll be able to market and sell your medical devices all over the EU without any restrictions.
Clarifies the background
The CER usually involves a comprehensive clinical background of your medical device which essentially summarizes all the research that has gone into the device. There are numerous components mentioned in the clinical background including the sources, the search methods used, the quality control measures that are undertaken, the selection criteria you utilized for literature review, and the findings. These multiple components make your CER very complicated, and you need someone experienced in formulating CERs for various companies to help you out. This will help you avoid any mistakes in the report so that the entire process is smoothly sailing. It becomes even more complicated due to the elaboration needed on various other topics like the target demographics, potential hazards, conditions treated, and many more.
Summarises your device
A CER is very crucial since it summarises all the functionalities and the associated risks of your device. This summary can be accessed by the notified bodies, agencies, and anyone else who wishes to understand your device better. The summary usually involves the medical indications of your device which help the users understand the adequate use of your device. Your readers will also get to know about the associated benefits and the possible risks of using your device. This is helpful since you’re clarifying the possible complications from the start, which will help save you from any future issues. You’re also supposed to mention the targeted groups of people at whom this device is aimed, this provides an additional layer of information to those who might potentially utilize your device.
These are some main points regarding a CER that you should be aware of before you start formulating one for your device. The CER can appear to be very lengthy and cumbersome at first but with the right assistance and data at your disposal, you’ll realize that it’s not that big of a deal. It’s a critical part of getting your device approved by European standards so that you can market and sell your product in every country in the EU. This is one of the biggest benefits of the CER; you get access to the multiple member nations of the EU, which is a vast market that can help you skyrocket your sales and profits. It also helps you get the CE marking which is one of the most recognisable and reputed markings in the medical device industry. All these reasons are enough to understand the importance of this report and going through a little trouble is acceptable if you’re getting the immense benefits that come along with it.
Ellen Diamond did her degree in psychology at the University of Edinburgh. She has an ongoing interest in mental health and well-being.
Psychreg is mainly for information purposes only; materials on this website are not intended to be a substitute for professional advice. Don’t disregard professional advice or delay in seeking treatment because of what you have read on this website. Read our full disclaimer.