DIGITAL HEALTH APPLICATIONS

A DiGA is considered a medical device with certain characteristics:

• It falls under risk classes I or IIa, according to the Medical Device Regulation (MDR) or the Medical Device Directive (MDD - until the end of the transition period).
• Their main function is based on digital technologies.
• It is more than an application for reading or controlling a device, the medical benefit must be achieved primarily through the main digital function.
• It is designed to recognise, monitor, treat or alleviate illnesses and to recognise, treat, alleviate or compensate for injuries or disabilities.
• They are not used in primary prevention.
• It is used either by the patient alone or together with medical staff, whereby applications that are used exclusively by doctors for patient treatment ("practice equipment") do not count as DiGA.
• It does not include any services that are excluded in accordance with the third chapter of SGB V or for which the Federal Joint Committee has already issued a negative decision in accordance with Sections 92, 135 or 137c.

DiGAs therefore act as "digital assistants" in the hands of patients.

• The "medical device" status is a basic requirement for a DiGA.
• In contrary to "pure" medical devices, DiGAs can also have positive effects that go beyond medical benefits. These are so-called "patient-relevant structural and procedural improvements" (e.g. increase in health literacy or adherence). On the other hand, a "pure" medical device (i.e. not a DiGA) that claims no medical benefit and only structural improvements would not qualify as a medical device at all.
• While in some cases, medical devices can demonstrate their benefits without actually conducting a clinical trial, DiGAs are always required to provide evidence with their own clinical data.

Rule of thumb - add them up:

• Your development time
• For class IIa: The certification period (approximately 10-15 months)
• Approximately 6-9 months for clinical trial
• 3-4 months for the application process

Manufacturers must provide sufficient clinical evidence. In contrast to CE labelling, clinical evidence based purely on literature or equivalence is not sufficient. For listing, manufacturers must generate their own clinical data. While a statistically positive trend is sufficient for provisional listing, statistical significance must be achieved for permanent listing. Although the source of the evidence is legally open (e.g. real world evidence data), the procedure has so far shown that a randomised clinical trial is the most promising method for confirming the postulated effects.

No detailed justification for the price is yet required as part of the provisional listing, which is why the price range sometimes goes up to around €2,000 per prescription.

The following factors should be considered:

• Effect impact
• Temporarily or permanently listed
• If the DiGA falls into groupings such as diseases of the musculoskeletal system
• Number of prescriptions
• Is it an orphan disease?
• Involvement of AI

The price may vary accordingly. Details can be found on the website of the GKV-Spitzenverband. Prices for permanent listings are currently levelling off at around €200.

No, this is not necessary.

In principle, the BfArM requires studies to be conducted in Germany. In rare cases, studies from other countries may be accepted. However, the manufacturer must provide sufficient argumentation regarding comparability with the German healthcare system.

The German Authority (BfArM) provides a comprehensive page with detailed information, including certification deadlines, technical information regarding connected infrastructure and further more: https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA-und-DiPA/DiGA2/Wissenswertes/_artikel.html

We offer comprehensive assistance:

• DiGA Fit Analysis
• DiGA concept development
• SW development
• AI support
• Assumption of the manufacturer function (Contract Manufacturer Service)
• Regulatory strategy
• Clinical strategy
• Fast Track Support
• Consultation with the BfArM
• DiGA Annex I: Data protection
• DiGA Annex II: Interoperability
• Price strategy