Learn how to safely pass the medical device approval process

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Introduction
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Prof. Dr. Christian Johner
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Quality Managers, Developers, Usability Engineers, Regulatory Affairs Managers, Risk Managers, Project Managers
Foundation
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veröffentlicht am 14.09.17
Is your product a medical device? The answer to this crucial question will have a major impact on the way you can develop, market and service your product. If your product falls under the definition of medical device, you have to comply with laws and standards, and implement quality management systems, software life cycle processes, usability and risk management. You must also provide comprehensive documentation. Your customers might even be affected, since the operation of medical devices is regulated as well.
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Start

Is your product a medical device? The answer to this crucial question will have a major impact on the way you can develop, market and service your product. If your product falls under the definition of medical device, you have to comply with laws and standards, and implement quality management systems, software life cycle processes, usability and risk management. You must also provide comprehensive documentation.

Your customers might even be affected, since the operation of medical devices is regulated as well.

Content

In this introductory training course you will learn:

     

  • the definitions of the term ‘medical device’ in both European und US regulations.
  • who will decide whether your product is a medical device.
  • what are the impacts of this decision.
  • how to classify products as a medical device and
  • what to do if you are uncertain.
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EU definition

The Medical Device Directive defines a ‘medical device’ as follows for the European market:

Let’s start with the first part of this definition: “‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software.” If we only read this first section, almost anything is a medical device. Even a table, a tree, a plane or a street would fall under this definition. All these are materials or articles.

Obviously, this definition is too broad, and we actually find the restriction in the next part of the text: “, intended by the manufacturer to be used for human beings for the purpose of…

It is crucial what the manufacturer intends will be done with the device. This is known as the ‘intended use’ or ‘intended purpose’. If the manufacturer intends that a table—to stick with the example—is used to have lunch, then it does not fall under the definition of medical device, since this has nothing to do with

     

  • diagnosis, prevention, monitoring, treatment or alleviation of diseases,” nor with
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,” nor with
  • investigation, replacement or modification of the anatomy or of a physiological process,” nor with
  • control of conception”.
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However, if the manufacturer intends the table to be used for surgery, i.e. for the treatment of diseases or injuries, then the very same table would fall under the definition of a medical device.

There are some exclusions: The definition only includes any product “which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means …”. Drugs, in particular, do not fall under the definition.

With a little bit of simplification, we can conclude that a product is a medical device if it is intended by the manufacturer to diagnose, monitor or treat diseases or injuries.

FDA

The US legal system uses almost the same definition of medical device: According to the United States Federal Food, Drug, and Cosmetic Act, it is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, which is intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

The main difference is that the FDA includes animals. Drugs are excluded, as in Europe, as they “achieve the primary intended purpose through chemical action.

Examples

Some examples will help us understand the difference between a medical product and a nonmedical product:

     

  • A CT scanner is a medical device since it is meant to diagnose diseases or injuries.
  • A hip implant is a medical device since its intended use is to compensate for a handicap.
  • A blood pressure meter is a medical device since its intended use is to diagnose diseases and, in particular, to investigate physiological processes.
  • An aspirin pill is not a medical device, even if it is meant to treat diseases. It achieves its intended action by pharmacological means.
  • A blood gas analyzer is a medical device. Its intended use is to diagnose diseases. Lab devices are called in-vitro diagnostic medical devices, a sub-group of medical devices.
  • A cross trainer is not a medical device, even if it prevents diseases, as it achieves its intended purpose by metabolic means.
  • And software, such as a hospital information system? This is exactly what we will be looking at in our next training course.
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End

By stating the intended use of a product, the manufacturer implicitly decides whether it is a medical device or not. He might express his intention in a user manual, in a product description, with marketing materials or websites. And sometimes it is just obvious.

However, there are manufacturers selling products that are medical devices by definition, but who claim they are nonmedical devices, and, conversely, there are manufacturers claiming their device to be a medical device, even if it does not fall under the definition.

Jail

If somebody files a lawsuit, you, as a manufacturer, may face legal implications: fines, jail, market banishment or publication on authorities’ websites.

Interview

Remarkably, in most cases, it is not the authorities or customers who file charges, but competitors. -- If you are uncertain whether your product is a medical device, ask a notified body, ask us or ask the responsible authorities. Unfortunately, the latter frequently do not respond promptly or only with nonbinding information. In the worst-case scenario, a judge will make a decision—eventually. However, this judge will refer back to exactly the definition of a medical device you have just learned.

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