SGS Debates on Mobile Medical Apps: Recreational or Medical Devices?

Popularity of smartphone applications – or "apps" - has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in.

Helsinki, Finland, February 02, 2015 --( Today the trend in healthcare is "patient centric care model." This is an addition to the previous five ‘P’s of modern healthcare: Prevention, Prediction, Personalization, Preemption and Personal Responsibility. The rise of smartphones as a ‘Swiss knife’ of personal healthcare matches extremely well with this trend.

What Is a Mobile Application?

History of applications developed for smartphone started with Apple iPhone 3G that was launched on 10 June 2008. At the same time, the App Store opened for developers and customers. Development has been rapid.

Recreational vs Medical Apps - Different Intended Uses

In many cases, a medical device is made of intended use. Distinction between a life style and a medical device depends on how the manufacturer describes the device. "Track your pulse rate to adjust your training into an optimal level" is completely different device from "Monitor your pulse rate to get an early indication of heart problems." The same distinction applies also to software.

Medical Apps Crossing into the Realm of Medical Devices

A well-known example of an app classified as a medical device is uCheck from Biosense Technologies, Inc. The pack consists of test strips, approved by FDA, reference color chart and an app for iPhone. User will use the test strip with urine sample and take a photo of the strip with the reference color chart. Software will give interpretation of the test results.

Conclusion made by FDA: "Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader." This means that the app is part of a regulated medical device. In Europe, a higher risk class medical device requires CE mark certified by a notified body, in the US, pre-sales approval from FDA.

Medical Device Directive and Classification of an App as a Medical Device

Medical Device Directive 93/42/EEC states a medical device should be noted that stand-alone software will always be classified as an active medical device and because of that classification rules (Annex IX in MDD) of 9-12 will apply.

The classification and interpretations have been further clarified by MEDDEV 2.1/6:2012 document: "Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices." The document describes that stand-alone software can directly control an apparatus, provide immediate decision triggering, or can provide support for healthcare professionals.

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has excellent web pages on the subject, such as "Guidance on medical devices stand-alone software."

Medical Devices and Mobile Medical Apps - Further Recommendations and Guidance

Instructions on when software will be regulated as medical devices, has been slow to progress. The FDA reacted first in 2011, when it published, "Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff." In short, the guidance states that apps to be regulated are those that meet the definition of a medical device:

1. Accessories to a regulated device
2. Transform a mobile device into a medical device

In the development of medical device software, a key standard is IEC 62304 Medical device software: software lifecycle processes. It provides requirements for the development and maintenance of medical software.

About SGS Medical Devices Services

SGS is one of the premiere organizations accredited for the certification of electro-medical equipment ( SGS experts can help executive level management, engineering professionals, compliance executives, legal departments, and medical professionals to better understand and comply with recent changes to standards and directives on medical devices safety.

For further information on SGS Medical Devices Services, please contact the SGS experts.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.
SGS Consumer Testing Services
Seppo Vahasalo
358 40 560 9500
Product Line Manager - Medical Devices
SGS Fimko Ltd
Särkiniementie 3
P.O.Box 30
FI-00211 Helsinki, Finland