In today’s age, every device used within the medical industry must be clinically evaluated to be approved and declared as safe, this applies to all medical instruments even those that would be perceived as low-risk. When you choose to work within the medical technology field, it is vital that you must be knowledgeable and up to date with the EU regulations that were implemented in 2017. The regulations set out changed the way that medical devices are approved, to be sold within the medical market.
What Does a CEV Include?
Now for those who have never completed a clinical evaluation report, the thought of doing so can be incredibly daunting and a challenge, to say the least. Being responsible for providing this report can be extremely overwhelming, as you may be concerned about just how much detail the report needs to hold and how many resources you will require to finalize it. The amount of information needed to complete this crucial report all depends upon the device, the more a device may hold significant risk to a patient, the more detailed it will need to be.
Clinical evaluation reports all need to consist of analyzed clinical data, that has been collected from conducting a clinical investigation on the device or by the results of the studies that have been carried out on devices that are considered to be equivalent. The clinical evaluation report will demonstrate that the instrument achieves the intentional purpose without leaving patients vulnerable to facing any further risk. It is essential that you understand just how much important detail a clinical evaluation report must include, here are some vital details to remember when writing a CEV.
Imagine Your CEV As a Single Document
The clinical evaluation report will be presented with a technical file or a design dossier. However, it is important to look at your CEV as the sole document, the document that holds all the power to hopefully approve the device with flying colors or unfortunately be denied. It is important to create your CEV to be as direct and incisive as possible and to begin with the basic structure, which should include information such as details of the device and the manufacturer.
It is essential to include information on the device’s intended purpose, the clinical evaluations, its intended application, and other specifications. Bear in mind, you need to comply with the EU’s ISO standards, so it is imperative that you add this relevant information.
Compare Your Device to Products Alike on the Market
When creating your clinical report, you will have the opportunity to compare your device to similar medical products that have already received the stamp of approval and have CE marking. It is imperative that you provide the data documenting and outlining the differences you have discovered between your device and those of similarity, particularly if you intend on using a number of different products to establish your device’s features. It is essential that you can provide the justification of just where and how you have found a correlation between your product and the other medical devices.
Include the Relevant Literature
In some cases, you will need to include clinical data that has been taken from the literature in your report. It is important that you follow an efficient and methodical process to ensure that you can provide relevancy to your document. Making sure in hiring a writer or choosing an individual to write the clinical evaluation report, who possesses the relevant knowledge and a clear understanding is imperative. They will know which information to include that will support your investigative findings and claims.
Establish If Clinical Investigation Is Needed
When you are dealing with a medical device that is considered to be high-risk, these specific instruments will need additional research to be conducted, to be able to finalize the clinical evaluation report. This is required especially if your device entails innovative features or exhibits new uses. It is the best idea to share your investigative findings and your clinical plan with the notified party before beginning further investigations.
Plan How to Monitor Post-Market Activities
Activities must be sufficiently planned and documented in the clinical evaluation report under the MDR and PMS. This also must include processes for when evaluating any continuous clinical data and also the updating of clinical evaluation reports must be recorded in the documentation. This ensures that the CER continues to be relevant all through the duration of the device’s lifespan. It is important to keep the CEV regularly updated, by evaluating the relevance of equivalent devices and documenting essential data.
Yes, writing a clinical evaluation report and knowing just what to include can be extremely complex and challenging. When writing your CEV make sure to include all the important details mentioned to help you ensure that your device is successfully approved.