Proposal to Simplify Regulations for Medical and In Vitro Diagnostic Devices

Proposal to Simplify Regulations for Medical and In Vitro Diagnostic Devices

Simplify Medical device regulations under EU MDR and IVDR.

Europe, 16 December 2025 — The European Commission has officially adopted a proposal to amend Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the EU Medical Device Regulation aims to simplify the regulatory rules, reduce administrative burden, and prevent shortages of critical medical devices. The proposal acknowledges that the current regulatory framework has created […]

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