Medical device manufacturers need to subject their products to a clinical evaluation.
This article briefly describes the objectives of the clinical evaluation, the regulations that you must meet to in this standalone software, and where to get the special support.
All medical devices must meet the essential requirements, which is demanded by the Medical Device Directive and thus also the Medical Devices Act MPG. These requirements include the following in a clinical evaluation.
The clinical evaluation of medical devices serves the following objectives:
Renounce of a clinical evaluation
For some products, even with many standalone software or Mobile Medical Apps, the question arises whether a clinical evaluation is at all reasonable and possible. The Medical Device Directive gives in Appendix X, paragraph 1.1d the opportunity to pass it up:
Where demonstration of conformity with essential requirements based on clinical data is not deemed necessary, such an exception shall be duly explained; this justification shall be based on the result of risk management and consideration of the specifics of the interaction between body and product, the clinical performances intended and the manufacturer's specifications. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and preclinical evaluation alone has to be duly substantiated.
Standalone software applications often implement algorithms to determine scores. Here one would not entirely do without a clinical evaluation, but prove that the algorithm has been clinically validated on the basis of the literature data shown. In addition, it would need to be verified, that the algorithm was implemented properly to validate the usability.
Clinical assessment and risk management
The clinical evaluation is also an essential prerequisite for risk management. Only the clinical evaluation justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio. The clinical evaluation will have to confirm the assumptions in the risk management file regarding the risks.
Clinical evaluation and validation
With standalone software the question is often raised about what could be clinically validated. The validation of the suitability for use shall be deemed by independent validation. Thus, the validation rather focuses on the effectiveness of algorithms, for example whether an image processing algorithm can detect tumors with reasonable certainty. In many cases for standalone software, similar to patient data management systems, the risks / side effects are in the foreground, rather than the clinical benefit. This clinical benefit is then determined from the avoidance of risks that one would have with an alternative, for example, with manual prescription of drugs instead of a computer-assisted one.
Clinical evaluation of Medical Apps
Many companies that develop apps can understand and implement the requirements of the IEC 62304 fairly quickly. Risk management is more difficult, especially when it comes to assessing the clinical benefit. This is necessary, because without benefit no risks are acceptable.
Each clinical trial (on patients), would wipe these manufacturers out of business, because the financial and time burdens would be too big. This is usually not necessary because the literature carries enough information. The crucial factor is the search strategy.
This search should concentrate, on the one hand, on the risks posed by the app (eg wrong medication caused by a programming error), on the other hand, they should concentrate on the benefits, eg on the risks that exist without the app, which the app reduces (eg medication errors due to incorrect calculation by hand). Hence there is the search strategy.
Part of the search could be to form two term classes and to link both with AND. The class includes phrase tags such as computers, CPOE, app or Electron *, the other includes phrase tags such as Adverse Event, Problems, Risk or Safety.
In order not to run into audit trouble, not only is the quality of the search crucial, but also the documentation and traceability. Excluding results without further explanation contradicts the principle of scientific work.
Since the auditors always take the careful clinical evaluation and their interaction with the risk management under the microscope (which, incidentally, I find very good!), I've decided to expand our team with a doctor: Dr. Matthias Werner MD immediately helps me and, more importantly, our customers when creating and checking these documents.
Do you have any questions regarding the clinical evaluation? Are you unsure whether your clinical evaluation meets the legal requirements? Do you want to know if you make too much or too little? Whether your clinical evaluation is congruent with your statements in the risk management file?
Let us know if we can help. We can not offer a complete review of your file for free. But we can answer many questions quickly, competently and free. Send us a message via web form or email (christian.johner [at] johner-institut.de).
The clinical evaluation is based on clinical data. This data may already be present - the clinical evaluation is then carried out on the basis of literature data - or they have to be collected as part of a clinical trial. These clinical trials in the form of clinical studies are laborious, time-consuming and expensive.
The notified bodies expect that you are using multiple sources / databases, for example
We all have no shortage of information. Least of all doctors. The medical literature database PubMed contains more than 20 million items. More than 150 items are added. Per Hour. And 365 days a year, 24 hours a day. No doctor can overlook this anymore, even if it focuses on the products of its own compartment. I understand that.
What I do not understand, or find difficult to accept, is the fact that it takes over 12 years until a published and correct discovery finds itself in the medical everyday practice. Over 12 years. This almost borders on bodily harm.
There are numerous regulations and standards that provide requirements for a clinical evaluation of medical devices. These include
These demands are particularly stringent on the clinical investigation of medical devices or in clinical trials. Further rules apply here:
The clinical evaluation of medical devices must be part of the technical documentation of every medical device.
With Auditgarant you get to learn these regulatory requirements for clinical evaluation in detail, and get specific tips on how to create this review quickly, condensed and in compliance with standards.