Bitkom has contributed to the public consultation on the revision of the Medical Device Regulation (MDR/IVDR) highlighting in particular the regulatory implications for digital health solutions and AI-based medical devices.
In principle, Bitkom supports the proposal to shift the MDR and IVDR into Annex I, Section B of the AI Act. This can help avoid double regulation and reduce unnecessary additional burdens on AI-based medical devices. Furthermore, Bitkom sees a significant need for improvement in Rule 11. In its current form the rule would often lead to the systematic overclassification of even low-risk digital solutions. This creates legal uncertainty, increases regulatory burdens, and can unnecessarily hinder innovation in the field of digital health applications
