Our cases
Clients about us
DiGA development: from the idea to the BfArM directory
The BfArM fast track assesses the application. Listing in the DiGA directory is the institute’s decision, not the vendor’s.
What a DiGA is, and what it is not
A DiGA is a medical device that insured people use to detect, monitor, treat, or alleviate a disease. Section 33a of the German Social Code, Book V, defines it, and the DiGAV sets the assessment. Reimbursement by the sickness fund starts only when the application is listed in the BfArM DiGA directory. A wellness app without a medical purpose, software used only by the practice, and a class III device are not a DiGA.
DiGA development here means building the application and preparing the technical file. The manufacturer files the application. The BfArM decides. The guide, dated 10 December 2025, version 3.6, is published by the BfArM. The requirements are in the DiGAV.
Requirements for listing
Four conditions have to be in place before the application. If one is missing, the BfArM three-month clock does not start.
Medical device
The application needs a completed conformity assessment. Classes I, IIa, and IIb can be a DiGA. Class III cannot. Classes IIa and IIb involve a notified body.
Used by insured people
The DiGA supports the insured person, alone or together with the treating provider. Software that only serves the practice or the hospital does not meet this condition.
Positive care effect
A positive care effect is a medical benefit or a patient-relevant improvement in structure and process. Permanent listing needs the proof. Provisional listing for the lower classes needs an evaluation concept.
Product properties
Privacy, data security, and interoperability must be evidenced with the application. Those duties do not fall away because the care effect will be shown only during the trial period.
A project from our work
Connect with students for live 1-on-1 college insights and tours
EXPERTISE
Education
TECHNOLOGIES
After listing: price negotiation and operation
Price in the first year
In the first year the manufacturer sets the price. Group caps and the threshold published by the National Association of Statutory Health Insurance Funds limit it. From 1 October 2026 the threshold is €0.84 per calendar day including VAT, in force until 31 March 2027.
Price in the first year
In the first year the manufacturer sets the price. Group caps and the threshold published by the National Association of Statutory Health Insurance Funds limit it. From 1 October 2026 the threshold is €0.84 per calendar day including VAT, in force until 31 March 2027.
Agreed price after that
After the first year the manufacturer and the association agree a reimbursement amount. If they do not agree, the arbitration board sets it. The published caps fall after more than 2,000 and after more than 10,000 redeemed activation codes.
Changes are notified
The manufacturer notifies the BfArM of significant changes to a listed application. The risk class remains an MDR question. That classification is covered on software as a medical device.
The app itself
We build the application, accounts, history, and activation in the project. That scope is custom mHealth app development. Listing does not replace the build.
Not every therapy app
Digital therapeutics without the German reimbursement path are not a DiGA. That wider scope is digital therapeutics development.
Operation without a listing promise
We do not promise a listing and we do not lower the evidence requirements. Interfaces to the record are a separate topic. The German page planned for that scope is Interoperabilität im Gesundheitswesen.
The BfArM fast track, step by step
Each line names the step, the deadline in the BfArM guide of 10 December 2025, and who is responsible. The deadlines are not a promise of listing.
Set the intended purpose
Before filing, the manufacturer defines which disease the application addresses and which class applies. Classes I, IIa, and IIb can be a DiGA. Class III cannot.
WhoManufacturer
Set the intended purpose
Before filing, the manufacturer defines which disease the application addresses and which class applies. Classes I, IIa, and IIb can be a DiGA. Class III cannot.
WhoManufacturer
Finish CE marking
Conformity assessment must be complete before the application arrives. For classes IIa and IIb a notified body assesses it. Section 3 of the DiGAV treats the CE mark as proof of safety and performance.
WhoManufacturer
Evidence the properties
Privacy, BSI security requirements, and interoperability are filed with the application. From 1 January 2025 a BSI certificate shows data security. The BfArM has set the privacy test criteria since 1 August 2024.
WhoManufacturer
Effect or concept
Permanent listing needs proof of a positive care effect. Provisional listing for the lower classes needs an evaluation concept. Class IIb needs the medical benefit with the application.
WhoManufacturer
File the application
The manufacturer files in the portal and chooses permanent or provisional listing. The BfArM runs the procedure under section 139e of the Social Code, Book V. An incomplete first filing does not start the review clock.
WhoManufacturer to BfArM
Make the file complete
If documents are missing, the BfArM asks for them. The deadline for that is up to three months. Only the complete application starts the review period.
WhoBfArM and manufacturer
Assess the application
The BfArM assesses a complete application in three months. In justified cases it can extend the period by up to three further months. The extension is the institute’s decision.
WhoBfArM
Decision and trial
The decision is permanent listing, provisional listing, or rejection. The trial lasts at most twelve months and can be extended once, twenty-four months in total. The manufacturer requests the extension at least three months before the period ends.
WhoBfArM, then manufacturer
What the BfArM checks
The left column is the DiGAV requirement, the middle is the evidence, the right is who supplies it. The table follows the guide. It is not a decision.
- No ranking, only the requirement that is checked
- Evidence under the DiGAV, not a score
- Without the evidence there is no listing decision
Timeline and cost
The periods come from the BfArM guide of 10 December 2025. The amount is the published threshold of the statutory-fund association, not a quote from WTT and not a development budget.
Review
3 months
after a complete application
- Supplements: up to three months
- Extension: up to three further months
- The clock starts only when the file is complete
- Version 3.6 of 10 December 2025
- No price list for listing
Trial
12 months
provisional listing
- Extendable once by up to twelve months
- Cap of 24 months including the review
- Extension request at least three months prior
- Class IIb: this path does not apply
- Class IIa: a concept can be enough
Threshold
€0.84
per day, 1 Oct 2026 to 31 Mar 2027
- Published by the fund association
- Including VAT
- First year: manufacturer price within the caps
- Then an agreed reimbursement amount
- Not the development budget
What clients say
INDUSTRY RECOGNITION
Luklabs
Acting CEO
The team is smart, creative, nice, calm, and professional, and they are problem solvers.
WTT Solutions paid attention to details. Most of their first iterations were very close to our intended designs. Consequentially, we didn’t have to do a ton of revisions in the QA phase.
I greatly enjoyed working with them.
Requirements for privacy, security, and interoperability
Sections 4 to 6 of the DiGAV apply in addition to the CE mark. From 1 January 2025 the BSI security requirements replace the earlier data-security annex. The source is the DiGAV.
Privacy
Personal health data need consent under GDPR Article 9(2)(a) and a narrow purpose limitation. The BfArM has set the test criteria for this since 1 August 2024.
BSI security requirements
The manufacturer shows data security with a certificate from the Federal Office for Information Security. We do not issue that certificate.
Interoperability
The application must export processed data in interoperable formats. The benchmark is the specification for the electronic patient record. Until that exists, recognised open standards apply.
Export into the record
Section 6a of the DiGAV requires export into the electronic patient record, in a human-readable form and under the current semantic and syntactic specification.
The duties stay
We do not lower the requirements for privacy, security, and interoperability. If a piece of evidence is missing, the application stays incomplete.
Proof of positive care effects
01
Two kinds of effect
Section 8 of the DiGAV recognises medical benefit and a patient-relevant improvement in structure and process. Either can carry the positive care effect. For class IIb the benefit has to be included.
02
Comparative study
For the medical benefit of a higher class, the DiGAV requires a prospective comparative study. Where suitable comparative data do not exist, the same applies to the care effect more broadly.
03
A 90-day example
An example of the design, not a completed study: class IIa, two arms, DiGA plus usual care versus usual care alone, 90 days of use, endpoint on day 90.
04
Registration and publication
The study is registered before the first enrolment and published in full. The BfArM receives the design and the results. This page does not set a sample size. The protocol does.
05
Class IIb has no trial listing
Provisional listing is not provided for class IIb. The study of medical benefit is already attached to the application. The BfArM states this in its DigiG questions.
06
A concept is not a waiver
The evaluation concept for provisional listing describes how the proof will be produced. It does not cancel the study. If the effect is not shown, the listing ends.
MDR classification of a DiGA
Since the Digital Act, classes I, IIa, and IIb can be a DiGA. Class III cannot. This summary follows the BfArM questions on class IIb and can change.
Class I
The lower class. Provisional listing for a trial remains possible when the other requirements are met and an evaluation concept is sufficient.
Class IIa
A notified body completes the conformity assessment before the application is filed. Provisional listing can still be open here.
Class IIb
Medical benefit must be shown with the application. A patient-relevant improvement in structure and process can be added. It does not replace the benefit.
Class III
The DiGA directory does not list class III devices. Naming another class in the application does not change the intended purpose.
CE first
For IIa and IIb the conformity assessment must be finished at filing, and the product must be able to be placed on the market.
Notified body
Classes IIa and IIb go through a notified body. That body does not grant the listing in the DiGA directory.
Intended purpose
The class follows from the intended purpose under the MDR. It is not chosen because one class makes the fast track look shorter.
The manufacturer stays the manufacturer
We build the software. The manufacturer under the MDR, and the applicant at the BfArM, remains the company that places the product on the market.
Example of a comparative study
An example of the design, not a completed study and not a result: a class IIa DiGA, a prospective comparative study with two arms, DiGA plus usual care versus usual care alone, use over 90 days, a patient-relevant endpoint on day 90, registration before the first enrolment. That is how section 10 of the DiGAV describes the proof. The protocol sets the sample size. The guide is published by the BfArM, and the caps by the statutory-fund association.
OpenAI
Google Gemini
Anthropic Claude
LangChain
LlamaIndex
Perplexity API
RAG / Pinecone / Qdrant
PostgreSQL
MySQL
MongoDB
Redis
Docker
Kubernetes
Terraform
GitHub Actions
Hi, I’m Serge!
CEO & Co-founder at WTT Solutions
Do you have a new project? Or want to say "Hello"...
