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The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a guidance document dedicated to digital health applications (DiGA) intended to be used in the country’s healthcare environment.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers (software developers) to ensure compliance with them.

The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

The scope of the guidance covers, inter alia, the aspects related to the application fees payable by the interested parties requesting the inclusion of their products in the respective register.

Application Fees and Expenses for DiGA

The BfArM imposes specific fees for processing applications and notifications related to DiGA.

These fees are outlined in Section 9 of the Digital Health Applications Ordinance (DiGAV) and are applicable for various procedures including the inclusion of DiGA in the DiGA directory, significant changes notifications, and other related processes.

As of December 20, 2022, the fee schedule (Section 24 ff. of DiGAV) for processing applications and notifications is detailed as follows:

• Application for permanent inclusion in the DiGA directory: 3,000 to 9,900 euro.
• Application for provisional admission to the DiGA directory: 3,000 to 9,900 euro.
• Examination of evidence of positive supply effects after preliminary admission: 1,500 to 6,600 euro
• Application for extension of testing: 1,500 to 4,900 euros.
• Notification of significant changes to the DiGA: 1,500 to 4,900 euro.
• Notification of the need for changes to information published in the DiGA directory: 300 to 1,000 euro.
• Removal of a DiGA from the DiGA directory: 200 euro.

The BfArM also reimburses any necessary expenses as per the Federal Fees Act. After completing an application or notification process, the applicant is issued a separate notice of fees. It is important to note that fees are also applicable if an application is rejected, an objection to a decision is made, or the applicant withdraws the application.

Furthermore, the authority mentions that manufacturers may seek a fee reduction or exemption under certain conditions, as detailed in Section 30 DiGAV.

This particularly applies to DiGA with a small target audience, rare use cases, or when the fees are disproportionate to the expected economic benefits of DiGA.

However, fee reductions are not applicable for applications for inclusion if individual applications are submitted for similar apps across different indication areas that are certified as individual medical devices.

Terms and Definitions 

The document also provides definitions of the most important terms and concepts used in the context of digital health applications.

The glossary included in the guidance covers various terms relevant to the application process and the broader context of DiGA, such as:

• Applicant
  Manufacturer of a DiGA or an authorized representative who applies to DiGA for inclusion in the directory.
  
• Authorized Representative
  A person or entity appointed to submit applications on behalf of the manufacturer, as per Article 2 paragraph 32 MDR or Section 3 Number 16 MPG.
• BfArM
  An independent higher federal authority under the Federal Ministry of Health, responsible for maintaining the DiGA directory and deciding on applications for DiGA inclusion.
• DiGA Directory
  A directory for digital health applications as per Section 139e SGB V, listing DiGA that can be prescribed or approved by health insurance companies.
  
• DiGA
  Class I or IIa medical devices that achieve their primary function through digital technologies, used by patients or jointly by doctors and patients.
  
• DiGAV
  Regulation outlining the procedure and requirements for the examination of the reimbursability of DiGA in legal health insurance.
• GDPR
  General Data Protection Regulation, governing the processing and free movement of personal data within the EU.

The summary also covers other key terms, such as Data Portability, Declaration of Helsinki, Diagnostic Instrument, Digital Supply Act (DVG), Digital-supply-and Care Modernization Act (DVPMG), DIMDI, EU-US Data Protection Framework, and FDA (US Food and Drug Administration).

Conclusion

In summary, the fee structure for DiGA applications and notifications is comprehensive and varies based on the type of application or notification.

The possibility of fee reduction or exemption exists under specific conditions, and the fees are applicable regardless of the outcome of the application.

The glossary provides a helpful understanding of the terms and entities involved in the DiGA application process and the broader digital health regulatory landscape.

Source

https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/diga_leitfaden.pdf?__blob=publicationFile

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