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Do apps need a CE mark?

Apps have rapidly become 'front and centre' in many people's lives. What started as a consumer oriented move has developed into other areas and now many companies have apps which provide their customers with ready access to information and more. It's likely to be the case that users wonder how they ever managed to get by without them.

The first apps were launched alongside the Apple iPhone 3G in June 2008 and could be downloaded from the App Store, which opened at the same time. The number of apps available for download has mushroomed. At the beginning of 2010, the App Store listed around 140,000. Today, that number has risen to more than 1million. In 2013, Google's Play Store listed 1.3m apps and claimed more than 50billion downloads by users of Android phones. Windows phones, however, are less well supported – only around 300,000 are available.

The rise of apps, however, would not have happened without the development of smartphones, whose large touchscreens enabled the interactivity required.

A range of apps has been developed for users in the electronics world. Examples include Electronics Toolbox Pro, iCircuit and Circuit Lab. Distributor RS Components has created a 'cut down' version of Electronics Toolbox Pro, which it calls the RS Toolbox App. It features colour codes, calculation tools, look up tables and is free to download. Digi-Key says its app is an engineer's tool which allows users to search for components, create parts lists, place orders and learn about new products.

On the face of it, apps are simply software and, as such, unlikely to be governed by any particular standard or directive. But one area where problems can arise is with an app that addresses a medical issue. So when is an app simply fun and when does it need to be regulated as a medical device?

Only a few years ago, joggers would monitor their heart rate using some kind of chest strap. Today, wearable electronics devices are taking over, offering such functionality as heart rate, distance travelled and calories burned, with the data transmitted to the smartphone using Bluetooth Low Energy, where it is analysed by the app. Such is the popularity of these apps, the market is estimated by Research2Guidance to be worth $58.8bn by 2020. Already, more than 4m such apps are being downloaded per day.

Seppo Vahasalo is product line manager, medical devices, with SGS Fimko. He said that, in many cases, a medical device is made for a particular use. "The distinction between a life style device – for example, a sports watch – and a medical device depends upon how the manufacturer describes that device.

"The statement 'Track your pulse rate to adjust your training to an optimal level' implies a completely different device from one which is said to allow you to 'Monitor your pulse rate to get an early indication of heart problems'. The same distinction also applies to software."

Developers of medical apps – but also developers of which address such areas as Directives – which might appear to give advice to the user, need to pay close attention to how they describe their apps.

Vahasalo gave an example of wordings. "A manufacturer is not always able to take cover behind the stated intended use. As one competent authority has observed: 'If it talks like a medical device, walks like a medical device and looks like a medical device, it does not help that you call it a recreational device'.

"There are apps used to measure heart rates and their variations. If the supplier intends to provide interpretations and diagnosis of the results, it may not be enough to state that 'This application does not replace real medical devices. All measurements made with the help of this application are introductory and should not be used for a medical conclusion of any sort'."

Crossing into the medical realm

Vahasalo said a well known example of an app which has been classified as a medical device is uChek from Biosense Technologies. The pack consists of test strips approved by the US FDA, a reference colour chart and an app for iPhone.

"People will use the test strip with a urine sample, then take a photo of the strip with the reference colour chart. Software will give interpretation of the test results," he said.

"But, according to the FDA, 'Since your app allows a mobile phone to analyse the dipsticks, the phone and device as a whole functions as an automated strip reader'. This means that the app is not just for fun, but is seen to be part of a regulated medical device.

"In Europe, a higher risk class medical device requires a CE mark certified by a notified body; in the US, such a device requires presales approval from the FDA."

According to Vahasalo, Medical Device Directive 93/42/EEC gives a good definition of what is a medical device. "It should be noted that standalone software will always be classified as an active medical device and, because of that, classification rules 9 to 12 in Annex IX of the Medical Device Directive will apply."

MEDDEV 2.1/6:2012, meanwhile, states that standalone software is considered to be an active medical device and adds that standalone software is defined as 'software not incorporated in a medical device at the time of its placing on the market or its making available'.

Alberto Paduanelli, lead auditor for medical health services with TüV SüD Product Service, said: "When it comes to apps, the question is will the software be considered a medical device? This document has a very good flow chart which guides users through the process. It asks what the software does and what is the intended use. The flow chart will tell you whether or not you need to comply with the Medical Directive."

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is said by Vahasalo to have some 'excellent web pages on the subject'. "Amongst the advice from MHRA is that whenever a manufacturer will use words such as 'amplify', 'analysis', 'interpret', 'alarms', 'calculates', 'controls', 'converts', 'detects', 'diagnose', 'measures' or 'monitors', it raises the probability that the app will be considered to be a medical device."

Of course, doctors, as well as members of the public, are using apps. According to the UK's Royal College of Physicians, in guidance to its members: "If you are using an app that should have a CE mark, but it is missing, then you are leaving yourself open to problems and possible litigation."

What about other apps?

Medical devices and software are, understandably, subject to extensive legislation and safety requirements. But if you have developed an app – or are in the process – do you need to make sure it doesn't fall foul of other European Directives?

Richard Poate, senior manager at TüV SüD, said: "If someone came up with an app to control something like a press, it would involve functional safety and the software would have to be tested rigorously. But it's hard to think of an app outside of the medical world that would need to comply with EC Directives," he concluded.

Author
Graham Pitcher

Related Downloads
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