“BREATHMENT” Wellness app or a Medical Device

“BREATHMENT” Wellness app or a Medical Device?

Is “BREATHMENT” a health and wellness app or a medical device app? This question arises with many products in this sector. Because both may measure parameters of physical performance and have a similar area of application. However, there is a fine line regarding the fulfilment of legal requirements and risk classification. The classification strictly follows the claims as well as the proposed usage of the product.

In this publication, we describe the difference by using the example of “BREATHMENT”.  This is an app developed with the background of the increasing worldwide viral respiratory diseases starting in the 2020’s. The technical capabilities and possible claims for the usage are evaluated against the different classification criteria.

Therefore, when evaluating the technical capabilities of “BREATHMENT” reasons can be found for any classification.

According to this, it is extremely important to clearly specify the intended use and functionality of the product. By doing so, the product can either be claimed as a health and fitness product, a class I or class IIa medical device DiGA.

As a result considering the time to market and the current availability restrictions of Notified Bodies (NBs) it is highly recommended to restrict the product functionality for a market launch as a wellness app for a quick win scenario. As the market offers many opportunities to grow without regulatory restrictions.

In the following step, we implement a QMS according to ISO EN 13458 and develop and validate class I medical app functionality in order to market as a DiGA to benefit from the reimbursability within the standard care of the national health insurance system.

After that, diagnostic features that result in a class IIa classification and therefore require more V&V activities should be developed and implemented, based on the need and availability of NBs.

Overview of the classification variety

The following table can serve as a rough orientation of the classification using the example of different pulse measuring functionalities. These tables provide only an exemplary overview. Exact classification may vary by the exact definition of the intended use as discussed later in this paper.

ClassificationIntended usePossible useAssociated risk
No classificationWristwatch with seconds displayUsed for pulse measurement by a medic.none
Health & Wellness devicePulse measurement for a wellness purpose.Used by patient with heart attack risk to control intensity of training.none
Borderline: probable health & wellness devicePulse measurement device for wellness purpose with data logging software.Generated and stored data used by a  medic to evaluate fitness activity of heart attack risk patient.none
Borderline: probable medical class IPulse measurement software for data logging and the claimed possibility to serve a medic for data analysis.Generated and stored data used by a medic to evaluate fitness activity of heart attack risk patient.moderate
Medical class IPulse measurement software for simplest medical purpose.Pulse measurement logging for general medical purpose.moderate
Medical class IIaPulse logging and analysis of pulse pause deviation to assist diagnosis.Diagnose heart function deviation by a medic.medium
Medical class IIbPulse monitoring (vital function)Live monitoring of pulse.high
Medical class IIIPulse monitoring in an intensive care scenario, with threshold alarm.Intensive care unit scenario where pulse falling below a threshold will result in a life-threatening scenario. Medic must be informed by an alarm.very high

For more information on this topic, you can download the whitepaper for free in our shop.

If you need further information please contact us.

Please note that a new version of the “MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under
Regulation (EU) 2017/745 on medical devices” was published after the press deadline.

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