Jusletter

Table of contents

• 1. Qualification of software and health apps as medical devices
• 1.1. Legal sources for software as medical devices
• 1.2. The notion of software
• 1.2.1. General terminology of software
• 1.2.2. Experts’ use of terminology
• 1.3. Software for specific medical use
• 1.4. Software with data processing: not limited to storage, archiving, communication, and simple search
• 1.5. The software can provide information about a specific patient
• 1.6. Wellness and lifestyle software
• 1.7. Mode of action of the medical device and distinction from the concept of a medicinal product
• 2. Medical device classification of software
• 2.1. General principles
• 2.2. Example of the contraceptive application
• 3. The challenge of conformity assessment and certification of health apps
• 4. Monitoring software as medical devices
• 4.1. Principles
• 4.2. Monitoring health apps
• 4.3. User confidence
• 5. The legal status of online platforms under MedDo
• 5.1. Online platforms as gatekeepers
• 5.2. Distributors or importers under MedDO
• 5.2.1. Natural or legal person established in Switzerland
• 5.2.2. Distributor or importer?
• 5.2.3. Making available on the Swiss market until putting into service
• 5.3. Impact of the Digital Service Act in the European Union
• 6. Conclusion