Can software be a medical device

When is software a medical device - and when is it not?

Everyone can imagine at least something under the term “medical product”. Most people would unequivocally identify a blood glucose meter for diabetics or a blood transfusion device as a medical product. However, items such as reading glasses, surgical gloves or cough syrup are also considered medical products.

However, what very few people know: Software can also be a medical product and is therefore also subject to the laws and standards that apply to ventilators or implants, for example. A classification is quite difficult, especially with software, and is often a matter of design. We clarify the terminology and explain why a correct classification is just as important as the product idea itself.

According to the Medical Devices Act and Regulation (EU) 2017/745 (also called Medical Device Regulation, MDR), medical devices include all products that are used for diagnosis, therapy, monitoring and prevention of health conditions. This does not include cosmetics, pharmaceuticals, blood, human transplants and animal tissue from living cells.

The trinity of medical devices

According to Regulation (EU) 2017/745, medical devices are divided into three subgroups:

  1. Active medical devices: Devices that are operated using an external energy source. This includes, for example, X-ray or inhalation devices. Software is also almost always classified as an active medical device.
  2. Non-active medical devices: Devices that are driven by gravity or muscles, for example, such as an ergometer for rehabilitation. But reading glasses or plasters also fall into this category, as no external energy source is required.
  3. Medical devices with a measuring function: Devices that measure blood pressure or body temperature, for example.

By the way: implants can be active, inactive or equipped with a measuring function.

Classification of the risk

The risk of medical devices is based on the vulnerability of the human body due to the product, which in turn is directly related to the location and duration of use. The higher the classification, the higher the risk, the more invasive the product or the longer the duration of use. There are a total of four "main classes" of medical devices:

Class I.

Low risk and non-invasive. These include reading glasses, wheelchairs and bandages, for example.

This also includes classes Ir (reusable surgical instruments), Im (e.g. manual blood pressure monitors) and Is (sterile products with lower risk)

Class IIa

Medium risk, invasive or non-invasive, short-term use. Disposable syringes, ultrasound or hearing aids fall under this classification.

Class IIb

Increased risk, implantable and / or invasive for long-term use. This class includes B. ventilators, defibrillators or infusion pumps.

Class III

High risk, implantable and / or highly invasive for long-term use. These include catheters, artificial joints and other implants, among others.

By the way: For all classes, with the exception of class I, manufacturers must consult a so-called notified body. Whether a medical product is approved by such a private, state-monitored test center can be seen, among other things, from the product's CE mark: If the CE mark is followed by a four-digit number, this clearly indicates a notified body.

When does software become a medical product?

The definition of classic medical devices should now be clear. But what about software? In contrast to hardware, this cannot be described as an independent device or object. Within the medical context, a general distinction is made between four types of medical software:

  • Software as part of a medical device (so-called embedded software)
  • Software as an independent medical product (so-called standalone software)
  • Software as an accessory for a medical device
  • Software that is not a medical device (health software)

Accordingly, software can be described as an independent medical product if it is standalone, i.e. not part of a classic medical product (such as a program that is built into ventilators). It must also be used for therapeutic or diagnostic purposes.

Attention: If software is part of a medical device, it is subject to the same specifications and regulations as the product in which it is embedded.

Why classification is so important

As a manufacturer of software in the medical context, you absolutely have to know whether it is a medical device or not. As with a defibrillator, the function of software must be ensured under all circumstances. For this reason, there are numerous guidelines, ordinances and standards that manufacturers must observe during development in order to protect patients and users. In addition, the manufacturer must prove the clinical performance, among other things, with studies and also consider aspects such as data protection.

The following standards are particularly relevant for this area:

  • ISO 13485 specifies that a comprehensive quality management system is required for both the design and manufacture of medical devices.
  • ISO 14971 regulates the application of risk management for medical devices.
  • IEC 62304 determines the life cycle requirements for software as a medical device.

The EU regulation MDR (Medical Device Regulation or European Medical Device Regulation) plays a central role for manufacturers, which will be mandatory in May 2021. In addition to the MDR, the IVDR, which deals with the area of ​​in vitro diagnostics, is relevant.

First think about it, then start

When it comes to developing software as a medical device, this aphorism is more than just a nice phrase. The classification of the program should be defined too early rather than too late, i.e. before the first line of program code is even typed. If the decision cannot be clearly made internally, it is worthwhile to seek external advice or an expert opinion.

We accompany you from the idea to the market launch

Most of our customers did not come to us with an initial algorithm, but rather earlier, with their idea for medical software - and that's a good thing! Because a medical program is worthless without taking into account the relevant standards, guidelines and regulations.

We not only take care of the programming of the software, but also accompany your product development process from the start: developing ideas, risk management, programming, launching and monitoring the software (keyword: post market surveillance and pharmacovigilance). With us you will not only find IT experts, but also a team of regulatory professionals who are always up to date on all matters relating to medical devices.

Do you have an idea? We look forward to your exciting projects!