Beschreibung
The European Commission began reviewing the MDR and IVDR in 2024. The results of this review are expected to lead to concrete legislative proposals. In particular, the aim is to reduce bureaucracy, speed up procedures, increase predictability and cost efficiency, and secure the future viability of Europe as a location for medtech and in vitro diagnostics. In order to provide solid facts for this discussion, the survey outlines the current situation regarding the impact of the MDR and IVDR on innovation, competitiveness, resilience, product availability and the special situation of orphan devices. Between 15 June and 31 August 2025, 267 companies from the D-A-CH region took part in the online survey, including 245 manufacturers whose responses were included in the evaluation.
