The EU’s Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) Regulations were introduced to strengthen public health protection and patient safety. However, a recent…
Commission publishes a Proposal for a Regulation to simplify MDR and IVDR
On 16 December 2025, the European Commission published a proposal for a Regulation to reduce and simplify rules on medical and in vitro diagnostic devices.…
The Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new transitional provisions for certain medical devices and in vitro diagnostic…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong the transitional provisions for certain medical devices and in vitro…