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.
If you are also struggling with this kind of question and the “MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under
Regulation (EU) 2017/745 on medical devices”, you can find more information in the PDF. And also get an overview with some examples.
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 wellness product, a class I or class IIa medical device DiGA.
For more information on this topic “wellness app or a medical device”, you can download the free pdf in our shop.
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Baturay Yalvac –
In diesem Artikel wurden die verschiedenen Angaben und ihre Auswirkungen auf die Einstufung einer Software als #Wellness-Produkt, als #Medizinprodukt der Klasse I oder als #Medizinprodukt der Klasse IIa im Fall von Breathment und seinen technischen Möglichkeiten untersucht.
Obwohl der Schwerpunkt des Artikels auf dem Produkt “Breathment” liegt, kann der Artikel als sehr guter Ausgangspunkt für jeden dienen, der die Auswirkungen verschiedener Angaben auf die Risikoklassifizierung einer “Software als Medizinprodukt” gemäß der Verordnung (EU) 2017/745 (MDR) verstehen möchte.