What Is the Purpose of a Clinical Evaluation Report?
In 2020, the European Union medical device market is estimated to be worth $122 billion dollars each year in revenue, which accounts for one-third of the world market annually. Due to the size and projected growth of the market for medical devices, there is obviously a need to expand upon the existing regulation of this market.
The European Union has enormous power in establishing global regulations, which can drive the harmonization of regulations around the world, a stated goal of the Global Harmonization Task Force (GHTF). Because of the sheer size of the multinational market, a medical device manufacturer is advised to comply with the regulations of its largest markets–this is because a medical device sold in Japan is often the same device sold in Europe. Therefore, many device manufacturers are ensuring that their devices are manufactured in accordance with strict European Union regulations, regardless of where they are sold.
In 2017, the European Union passed the landmark EU MDR (European Union Medical Device Regulations). This piece of legislation repealed and updated the EU MDD (Medical Device Directive) passed in 1993. Let us look at how EU MDR has affected the steps a medical device must take before it enters the market and how one of the most important components is the CER (Clinical Evaluation Report).
However, before the CER can be completed, a clinical evaluation must be completed. We will also take a brief look at what a clinical evaluation consists of and the importance of a literature review for medical devices.
What Changes Did EU MDR Make to the Medical Device Market?
The European Union Medical Device Regulations prioritized patient safety and performance as a key part of their policy. They also updated lists to cover new devices previously not covered, including products not intended for medicinal use such as cosmetic devices like liposuction and skin lasers, as well as cosmetic contact lenses.
One of the ways the EU MDR focused on patient safety was by updating the requirements for clinical evaluations. This includes not only a pre-market assessment but also a post-market assessment, known as a Post Market Clinical Follow Up (PMCF). Device Manufacturers must proactively and continually collect clinical data regarding the use of the device in the market after it has been released. This ongoing process is done to validate the performance and safety of the device against claims made of the device by manufacturers while identifying potential present or emerging risks that may arise as a result of the clinical data collected.
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Why Is Clinical Evaluation Important, and What Is the Purpose of the Clinical Evaluation Report?
The bottom line is that without a clinical evaluation, there can be no clinical evaluation report. Medical devices that have not completed a clinical evaluation report are not considered for release on the European Union market. The completion of the clinical evaluation and the following report is therefore crucial steps in this process.
The clinical evaluation report (CER) itself is a compilation of the clinical data gathered during the clinical evaluation. It shows the clinical evidence for the device’s efficacy in treating any claimed disorder, condition, or disease the patient may have. Additionally, the report will contain safety data regarding the devices used in a clinical setting to ensure it has no adverse effects on the patient.
Should irregularities be found, or if the device to be marketed and sold is a medium or high-risk device, additional requirements must be met. One of these is a clinical investigation. One might think that a clinical evaluation and a clinical investigation are the same, but the clinical investigation is a much deeper assessment of the device and includes the systematic investigation of the device in one or more human subjects. Clinical investigations may also be required if an existing device is updated with additional technology and has added a new use for the device to treat a condition for which it was not previously approved.
Tools to Assist in Clinical Evaluations and Reports
Part of the process of evaluating and reporting on any device will often involve examining prior clinical evaluations and reports regarding similar devices. This is an extremely time-consuming process and requires a lot of literature review for medical devices. Fortunately, software such as DistillerSR can make the process of searching and examining clinical reports much easier and can help devices reach the market faster by expediting the clinical evaluation process.