What is the definition of a medical device?

Why it is important

It can make a world of difference if you know what the definition of a medical device is – and is not. This is true both if you are selling a product that you don’t think is a medical device when it in fact is, and the other way around. This may also be true if you plan to sell a product that is a medical device, that you think is a medicinal product or drug, or vice versa.

If you are selling a medical device in the EU or US, you are required to fulfil certain regulatory requirements. Not to do so is a criminal act; thus it really makes sense to get your product correctly classified. Furthermore, the advantage of ending up with a medical device as opposed to a drug is that the cost and time required to gain market access is in most cases significantly less for a medical device compared to that of a medicinal product.

In layman’s terms, a medical device is something that is used for surgery, therapy, or diagnosis. In the EU, some contraceptives are also considered as medical devices, as well as stand-alone software.

Medical device definition EU

The more formal definition in EU of a medical device can be found in the medical device directive, 93/42/EEC Article 1 §2:

(a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

Medical device definition US

In US, the definition comes from Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
– recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
– intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

There are some products that you may believe to be drugs, but when looking at them in more detail you may discover that they do not achieve their primary purpose by pharmacological, metabolic, or immunological means. This means that the product may not be a medicinal product, but rather a medical device. This is true for some IVF media, tissue and organ preservation solutions, and products using enzymes or bacteria that have an effect on viruses and bacteria but not on the body itself.

More reading

If you are in doubt about whether your product is a medical device or not in the EU, you may consult the current versions of the following references:

– Meddev 2.1/3 Borderline products, drug‐delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative
– Manual on borderline and classification in the community regulatory framework for medical devices
– Meddev 2.4/1 Classification of medical devices

FMEA and Risk management according to ISO 14971

Risk management vs FMEA

Risk management for medical devices is a comprehensive approach, including requirements for planning the development of a device, to the requirements for a device that is no longer on the market. Even though the standard in application of risk management to medical devices has been around for almost 15 years, there is still some confusion on what is risk management and FMEA.

What is risk management according to ISO 14971?

Risk management according to ISO 14971 should include a process that comprises everything from management’s involvement in risk management, to how one should manage risks after a device has been put on the market.

ISO 14971 indicates that the risk analysis is part of the risk management process, which is designed to identify hazards, decide what they can lead to and how much risk is associated with different hazards. Thus, risk analysis is only one part of several in the process as a whole. Often, however, the term risk analysis is used for risk management as a whole. In addition to that, risk analysis is sometimes used synonymously with Hazard traceability matrix.

What is FMEA?

FMEA stands for ”Failure mode and effects analysis”. There is an IEC standard that describes what FMEA is (IEC 60 812). If you turn to the ISO 14971 standard it states:

“Failure Modes and Effect Analysis (FMEA) is a systematic procedure for the analysis of a system to identify the potential failure modes, their causes and effects on system performance (performance of the immediate assembly and the entire system or a process).”

From this perspective of the ISO 14971 standard, FMEA is a reliability tool. The method is based on how failure of components or sub-systems of a product affect the system as a whole, and that is an important difference from risk management according to ISO 14971.

ISO 14971 is based on the hazards that may exist in the product, e.g. virus, gas at high pressure, radiation or a sharp edge. Based on these hazards, a number of events can be identified, which can lead to hazardous situations and harm to people, property or the environment.

Risk management video course

Take the free 30-minute introductory course of risk management for medical devices according to ISO 14971

SEE ALSO: Full online ISO 14971 training course

FMEA according to IEC 60 812 takes the position of how a component may malfunction (local effect), such as break apart, fall out, change shape, and then analyses what kind of system effect it results in. This means that you cannot successfully work with FMEA until relatively late in the process of product development, because you need to have designed most components and sub-systems in order to determine how the components can fail and the consequences of that. As long as they are not designed, it is difficult or principally impossible to do the analysis.

The main difference between risk management according to ISO 14971 and FMEA is that FMEA is tended to only find the risks associated with something broken. In addition, FMEA does not deal with acceptable and unacceptable risks, but only provides a priority order in which to work with risks. The RPN number (Risk Priority Number) is derived from the FMEA method.

A generic process for risk management according to ISO 14971 compared with the steps in Failure Mode Effects Analysis.

A generic process for risk management according to ISO 14971 compared with the steps in Failure Mode Effects Analysis.

In FMECA, an extension in the form of the term ”Criticality” has been added to the abbreviation, i.e. one also studies the severity of harm to a patient/user due to a faulty component. With its addition, the method is more similar to risk management according to ISO 14971 as it identifies the harm. However, the method still emanates from component failures, and not hazards, which ISO 14971 does.

FMEA’s role in medical device risk management

If the product you are working with has essential performance, i. e. it has to function to be safe. If the product needs to function to be safe, the reliability is important, thus the FMEA should be considered. Even so, the FMEA will only be part of the overall risk management process and primarily focus on parts of the system that are essential to the performance.

If you perform only FMEA as defined in IEC 60812, you will not comply with the requirements of ISO 14971.

You can download a free template for risk analysis and risk management for ISO 14971 here.

Where to buy and download the ISO 14971 standard as pdf

The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971 on Risk Management is to purchase it from a web-store and download it as a pdf. But the prices may vary greatly depending on where you choose to buy the standard. Below I have listed some different sources/stores where you can buy the standard together with pricing information (correct as of June 2014). The prices are stated without subscriptions or memberships in the various web-stores:

Store URL Price
British Standards Institution www.bsigroup.com 395 USD
ANSI www.ansi.org 259 USD
Swedish Standards Institute www.sis.se 192 USD
Estonian Centre for Standardization www.evs.ee 30 USD

Buying the standard from the British Standards Institution will cost you a staggering 13 times more than buying it at the Estonian Counterpart. And the content is the same, that is the whole idea with standardization!

SEE ALSO: Free online ISO 14971 training course

Not only is the Estonian Centre for Standardization offering the ISO 14971 standard (and many other standards) at a much lower price than their larger European and American competitors, but they also have an excellent service that allows you to access the full text of the standard for 24 hours for 2€ or a little less than 3 USD. That is an excellent way of checking whether or not a standard applies to your product.

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