European Commission Publishes Proposal to Simplify MDR and IVDR Regulations
On December 16, 2025, the European Commission adopted a new proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The proposal aims to streamline the regulatory landscape for medical devices in the EU is expected to transition from a phase of implementation challenges to a more structural, streamlined, …