Digital Healthcare Treatments
The Digital Supply Act (DVG), which came into force on 19.12.2019, aims to digitize healthcare in Germany
the DVG stipulates that the decision on the provision of services in standard care lies with the “Federal Institute for Drugs and Medical Devices” (BfArM). According to § 33a SGB V, have the right to be supplied with medical devices according to the new “Medical Device Regulation” (MDR). According to the legislator, these are all medical devices of class I and II a. The main function of these “health applications” must be based on digital technologies and must help or support the patient or provider to recognize, monitor, treat or alleviate illness or compensation of injuries or disabilities.
We can advise and support you in implementing such projects in accordance with the new legislation and ensure that your software represents a medical device of the appropriate class and is compliant. In us, you have a competent partner who, in you, is pushing the digitalisation of health care.
In addition, we will happily advise you in a global context when it comes to software as a medical device.