The position paper emphasizes the need for a balanced approach — one that ensures a high level of patient protection while remaining practically applicable for economic operators, with particular focus on introducing a recognition mechanism for CE-marked devices to avoid redundant regulatory assessments and enable faster patient access to products already available on the EU market. Through a structured set of recommendations, AmCham seeks to support the establishment of a predictable, efficient, and European-aligned regulatory system for medical devices, while remaining a committed partner to the relevant institutions in the continued dialogue and finalization of this legislation.
