Business owners often struggle with the section of the MDR requirements that explains what must be included in a medical device clinical evaluation report. This tutorial should help address many of the questions you may have about the report, which is necessary for selling medical devices on the EU market. You must be familiar with this process if you manufacture medical devices and intend to sell them in the EU.
Exactly what is a clinical review of medical equipment?
To ensure their effectiveness and safety, medical devices must undergo testing before they may be put into clinical use. Clinical settings are suitable for this kind of testing and may even involve trials on actual humans.
Continual clinical evaluation is the systematic gathering and analysis of relevant clinical data. A clinical evaluation aims to confirm that a medical product is safe and effective for its intended purpose.
The clinical evaluation report consists of the following sections:
This report aims to objectively convey the information acquired during the clinical examination of the medical equipment. The article features contributions from a wide range of professionals, including manufacturers, quality specialists (for complaint data), safety experts, librarians, and scientists. There are a few things that must be included in the CER:
Condition of the medical gadget and the clinical setting as a whole. How does this thing work, and what is it made of? What can we learn from analysing the results of published studies and conducting follow-up research after a product has hit the market? How does one arrive at a conclusion using the risk-benefit analysis? The length of such a summary typically goes beyond two pages.
Clinical evaluation’s scope
Where can I get information on the objectives, criteria, and benchmarks used in CER assessments? The scope should support the device’s ability to fulfil the MDR’s basic safety and performance criteria. The purpose of the CER is also specified in the scope, such as whether it is for a first-time CE marking, a CE mark renewal, or because of a request from a notified authority.
We used it to gauge the effectiveness of the existing apparatus. Research on the current state of the art for similar devices led to this conclusion. This investigation was carried out apart from the gadget’s examination.
Device under evaluation
Provides enough information about the medical gear’s specifications to guarantee it meets the essential requirements. Images, graphics, and usability test findings are welcome content additions. Functional equivalence must be demonstrated through the utilisation of the biological, technical, and clinical qualities of the device being sold as an equivalent to another device, as well as through pre-clinical studies, post-market surveillance, and pre-market clinical examinations. Finally, the report concludes with a systematic review of the relevant clinical literature. It can take as much time to write as the rest of the CER itself.
This part gives a concise technical and physical description of the device in light of the available clinical evidence and a summary of the therapeutic or diagnostic claims made for the device. The medical device clinical evaluation is summarised, and the data forms and analysis of the clinical data are provided.
The next scheduled medical examination date
CERs must be updated at regular intervals, and this must be communicated to stakeholders alongside the notified body’s audit and certification renewal process. These may be revised within five years, depending on the severity of the threat posed by the medical device in question.
When it comes to proving that medical equipment is both safe and effective, nothing beats having a clinical assessment report as part of the CE technical file. This is not a non-essential piece of paper. A separate CER document will make it easier to update it regularly as required by the agreement with notified companies. Remember that getting your medical device certified depends on the CER being finished or updated.