Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2018
Review[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?]
Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector. For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device. ⋯ This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2018
Review[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].
Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy. Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. ⋯ The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device. Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2018
[Requirements for CE-marking of apps and wearables].
Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. ⋯ Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.