The new article highlights the aspects related to the timeframes the applicants should follow.
Table of content
The German regulating authority of Healthcare Products (BfArM) has published a guidance document dedicated to the regulatory requirements for digital health applications (DiGA) intended to be used in the country.
The document provides an overview of the existing regulatory framework, as well as additional clarifications and recommendations to be considered by medical device manufacturers (software developers) to ensure compliance thereto.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
The application process for the Digital Health Applications directory is a detailed and structured procedure, exclusively conducted through the BfArM application portal.
This comprehensive process not only involves the initial submission for inclusion in the DiGA directory but also extends to various other aspects such as submitting documentation at the end of the trial period, applying for an extension of this period, and notifying significant changes to the DiGA following Sections 18 and 19 DiGAV.
The present guidance provides an in-depth look into the practical and administrative elements of this application process.
Timeframes for Applicants and BfArM
The application process begins with the manufacturer’s submission through the BfArM portal.
Once the application, complete with all mandatory information and required attachments, is received by the BfArM, an entry check is initiated. This check is crucial as it determines the formal completeness of the submitted documents and evidence.
The applicant is assured a response from the BfArM within a 14-day timeframe. In cases where the application is deemed incomplete, the applicant is granted up to three months to submit the necessary additions or changes.
The processing of the application formally commences once the BfArM receives these complete documents, triggering a legally stipulated maximum evaluation period of three months.
This period concludes with either the application’s inclusion in the directory or a rejection notification.
Life Cycle of a DiGA in the Directory
After a DiGA is successfully included in the directory, it enters a new phase where specific rights and responsibilities apply.
This phase is critical as it governs how the manufacturer must proceed, especially in instances of changes to the DiGA.
The authority additionally emphasizes that understanding the implications and requirements post-inclusion in the directory is essential for the manufacturers.
Changes to the DiGA
In the event of necessary changes or additions to a DiGA, these modifications are only permissible when approved by the BfArM, and only provided a decision from the BfArM is received.
This stipulation ensures that any modifications are in line with the regulatory requirements and are adequately documented.
If the BfArM’s additional requests for information or documentation are not satisfactorily met within the prescribed deadline, the application faces the risk of rejection.
Advice from the BfArM
The BfArM’s advisory services are a valuable resource, especially after the application process is completed.
These services are particularly beneficial for DiGAs listed for testing purposes, as they guide critical aspects such as the extension of testing periods and the categorization of changes to the DiGA under Section 18 DiGAV.
Application Process via the BfArM Portal
The central hub for all application-related activities is the BfArM portal. This portal streamlines the process, making it straightforward for manufacturers to submit initial applications, provide necessary documentation at the end of the trial period, and communicate significant changes to the DiGA.
Response and Processing Periods
Upon submission of an application, the BfArM is committed to responding within a 14-day window.
This response is followed by a maximum evaluation period of three months, which is a crucial time frame for the application’s processing.
During this period, decisions, including potential rejections, are formulated and communicated.
Additionally, there is a provision for lodging objections to these decisions within a month of their publication.
Additional Requests and Subsequent Deliveries
The evaluation period often involves additional requests from the BfArM for more information or documents.
According to the guidance, the manufacturer’s ability to respond adequately within the set timeframes is critical.
Failure to meet these requests can result in the application being rejected, highlighting the importance of timely and comprehensive responses.
Withdrawal and Resubmission of Applications
Manufacturers have the flexibility to withdraw their application, which can then be resubmitted at any time, provided no final decision has been issued.
In cases where a DiGA, initially included for testing, receives a negative decision for final inclusion, a new application can only be submitted after a twelve-month interval, and that too with new evidence.
Conclusion
In summary, the DiGA application process managed through the BfArM portal is a detailed and regulated procedure requiring strict adherence to guidelines and timeframes.
The present guidance emphasizes the importance of comprehensive documentation, understanding the lifecycle of a DiGA post-inclusion, and being responsive to the BfArM guidelines and additional requests.
For manufacturers, this journey demands meticulous attention to detail and proactive engagement with the BfArM requirements to ensure a successful application.
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