Clinical Affairs
Clinical evaluation of medical devices under the MDR
Clinical evaluation is becoming more of a relevant topic for authorities, notified bodies, and the manufacturers of Medical Devices, due to the Medical Device Regulation (EU) 2017/745.
Unfortunately, the clinical evaluation is often misinterpreted as an obstacle, and the meaning behind it is often lost. The clinical evaluation represents the core philosophy of the MDR, which secures the safe and performance-based application of Medical Devices through measures such as planning or documentation of standard operating procedures.
Your device is safe. Are you able to confirm this?
Every Medical Device has a risk-benefit ratio. With this risk-benefit ratio, the benefit must outweigh the risk. This relationship can be more or less clear. With a normal scalpel, this ratio is pretty obvious. But what about a laser scalpel? Does the risk factor still clearly outweigh the benefit? Is the device state of the art?
These exact facts are the kinds of topics that the clinical evaluation report researches. The report analyzes the risk-benefit ratio and questions the indications which can be used on the device. At the same time, the risks are studied. To aid this, scientific articles, clinical studies, and information from the Post-Market Surveillance System are used.
Subsequently, all risks are set against the benefits and compared with the state of the art. From this, one can confirm or deny if a device is safe, and if the intended therapy is appropriate for the time. The most important question to be asked in this situation is if there is an alternative that will provide the same outcome with less of a risk factor. One example is the insulin therapy pen pump or shot.
Definition of Clinical Evaluation in the MDR
The MDR defines the term “clinical evaluation” in article 2 (44) as follows:
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
The clinical evaluation is also a continuous process that continuously checks the safety of a Medical Device and the benefits that have been found through the usage of a medical product and will weigh up the resulting risks.
Hereby, a systematic, scientific literature review takes place which in some cases must be supplemented with clinical trials or clinical studies with the Medical Device that is to be evaluated.
The legal relevance for the clinical evaluation results from Article 61 and Annex XIV Part A of the MDR. Manufacturers of Medical Devices, whose device is being distributed in the EU, are required to create technical documentation which accompanies the clinical evaluation report. The clinical evaluation has to be made regardless of the product classification and is a requirement for all Medical Devices.
Because of the immense differentiation between medical products, the MDR has generalized the requirements, so as to allow them to be applicable to all Medical Devices.
Therefore, the MDR requires in Article 61 (1):
“The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.“
Here the term “clinical evidence” is not defined. As a manufacturer of a Medical Device, you must be able to recognize what a literature search must entail so that you can be sure that the basic safety and service requirements are sufficient according to the MDR Annex I. Additionally, you must decide if a clinical trial is necessary and justify your reasoning. Adequate management does not only require regulatory knowledge but also experience in the field of clinical evaluation.
Basic constellations of clinical evaluation
Four basic constellations can be distinguished that must be taken into account when preparing a clinical evaluation and that significantly determine its scope.
- Evaluation of a device already on the market
- Evaluation of a successor of a device already on the market
- Evaluation of a completely new product, which is comparable to already existing devices on the market, and that is used for an established medical procedure.
- Evaluation of a device that is not comparable to other products in the market, or of an established product that is to be used for a completely new indication/application.
Which guidelines are currently applicable?
The golden standard for creating a clinical evaluation was long set by the MEDDEV-Guideline 2.7/1 Rev. 4. But this standard is no longer sufficient for the MDR. So what can one refer to? The MDCG regularly creates new guidance documents that pertain to the topic of clinical evaluation and thereby replaces the MEDDEV document, but not all gaps are yet closed. This makes it all the more important to work in a scientifically sound and comprehensible manner and to have a good overview of the requirements that the clinical evaluation report must meet.
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