How to get your Digital Health Application reimbursed in Germany? (DIGA)
In Germany, a new law was issued for Digital Health Application. To help us understand the content of this law, I have asked Stefan Bolleininger who is helping companies to send an application for it. The name of this application is called DIGA. The acronym will be explained to you in this episode. And we will also explain which app is in and out of scope. What is important to understand if the fact that this law requires you first to be a medical device and then to have your CE mark for it before to get approved for DIGA.
Who is Stefan Bolleininger?
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Stefan’s LinkedIn Profile: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Be-on-Quality website: http://www.be-on-quality.com/
- The german law http://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&jumpTo=bgbl120s0768.pdf
- The German Institute https://www.bfarm.de/DE/Medizinprodukte/DVG/_node.html
- The DIGA guidance: https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Beratungsverfahren/DiGA-Leitfaden.pdf;jsessionid=E7B0133B29FAF6555378DC6063271D7E.1_cid507?__blob=publicationFile&v=2