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.