The European Commission’s feedback round is already the second round in which various stakeholders can submit their feedback on the classification of software under the MDR. The first round mainly served to identify implementation problems, while the second round specifically targets the clarification of requirements and suggestions for improvement.
The SVDGV, as the joint voice of eHealth providers and supporters in Germany, has also submitted its feedback together with other representatives of the digital health industry, criticising the fact that even apps with a low risk to users, such as dyslexia tools, are disproportionately classified as class IIa. The associations are calling for risk-appropriate implementation so that DiGA become accessible to patients quickly and efficiently and Europe remains internationally competitive.
Read the joint statement at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules/F33073337_en