BfArM provides advice for medical app manufacturers as of April

As already reported previously, the DVG (“Digitale-Versorgungs-Gesetz”, law for medical apps) is effective since December 2019.

The federal institute for pharmaceuticals and medical devices (BfArM) is responsible for the admission of requesting manufacturers’ medical apps as so-called “DiGAs”. With this admission, they can be reimbursed by the statutory health insurances.

How this admission should look like, was unclear so far.

During the health innovation hub on March 31st, BfArM and the federal ministry of health (BMG) will inform about the DiGAV, the process and the requirements regarding evidence.

Expectedly as of April, BfArM will advise potential applicants concerning their medical apps/DiGAs.

Due to the recent situation of the Coronavirus, the complete health innovation hub event will take place online. please find here more information.

We will take part in the event and will keep you up to date for any news and developments.

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