DiGA - digital health
applications
For manufacturers and programmers of digital health applications (DiGA), the path to successful approval in Europe and Germany is a complex process. MEDAGENT guides you through the jungle of requirements to make this process transparent and navigable.
Here is a detailed presentation of the requirements and steps necessary for the
conformity assessment and CE approval of DiGA.
Steps for the development and approval of a DiGA
The first step is to develop a clear concept that defines the medical purpose of the DiGA. This is crucial for the subsequent risk classification.
The DiGA must comply with the requirements of the MDR. These include clinical evaluation, safety, performance and quality management.
DiGA are divided into classes according to risk potential (I, IIa, IIb, III). The classification depends on the purpose, the duration of use and the extent of contact with the body.
In Europe, the risk classification of DiGA according to MDR is as follows:
– Class I: Low risk, e.g. health apps to promote a healthy lifestyle.
– Class IIa: Medium risk, e.g. apps for monitoring physiological processes.
The classification influences the conformity assessment procedure and the requirements for clinical evaluations and technical documentation. Other applications, e.g. for monitoring physiological processes or controlling medical devices for life support, are regarded as independent software and may be assigned to risk classes IIa, IIb and III.
Development in compliance with regulatory requirements
Development must be based on the applicable standards and guidelines to ensure conformity:
- Conducting a clinical evaluation Proof of the clinical efficacy and safety of the DiGA
- Preparation of technical documentation. This documentation includes all details on the development, function, manufacture and testing of the DiGA.
- Implementation of a quality management system. A QMS is required to ensure compliance with the MDR and other relevant standards.
- Application for CE marking and implementation of the conformity assessment procedure. If the DiGA is assigned to risk class IIa, IIb or III, an application must be submitted to a Notified Body to carry out a conformity assessment. DiGAs that are assigned to risk class I must be assessed under the manufacturer's own responsibility as to whether the requirements of Regulation (EU) 2017/745 are met. This is documented in the technical documentation.
- Market access and post-market surveillance. After receiving the CE marking, the DiGA can be marketed in the EU, whereby continuous post-market surveillance is required.
Additional requirements for DiGA in Germany with regard to eligibility for reimbursement
Legal basis
Since December 19, 2019, the Digital Healthcare Act (DVG) has regulated that insured persons in statutory health insurance are entitled to receive DiGAs that can be prescribed by doctors and psychotherapists and reimbursed by the health insurance company.
The prerequisite for this is that the DiGAs have successfully passed a test procedure at the BfArM and are listed in the DiGA directory. This directory summarizes key information on the DiGA for doctors, psychotherapists and users. This ensures comprehensive transparency so that well-informed decisions can be made and trustworthy use is possible.
The procedure and requirements for checking the eligibility for reimbursement of the DiGA are regulated in the DiGAV
A high standard of data protection and data security is mandatory, whereby the DiGA must comply with both the German Federal Data Protection Act (BDSG) and the EU General Data Protection Regulation (GDPR). In addition, the DiGA should be designed to be user-friendly to ensure ease of use for a wide range of patients, including people with disabilities.
The role of the BfArM in the approval of DiGAs
The Federal Institute for Drugs and Medical Devices (BfArM) evaluates the submitted evidence for the medical benefit and safety of DiGA. This includes an assessment of whether the DiGA achieves the claimed health benefits. Through the fast-track process, the BfArM aims to evaluate and approve applications in a short timeframe. This process ensures that innovative digital health solutions can reach patients quickly.
Once approved, the DiGA is listed in the official DiGA directory. This listing is crucial as it enables doctors to prescribe the DiGA and get it reimbursed through statutory health insurance. Once approved, the BfArM continues to monitor DiGA to ensure ongoing compliance with regulatory standards and to reassess its medical benefits and safety.
Understanding and navigating the specific requirements of DiGA in Germany, particularly the role of the BfArM, can be complex. MEDAGENT is dedicated to guiding developers through this complicated process and utilizing our expertise to facilitate the smooth approval and integration of your DiGA into the German healthcare system.