MDR
In forceRegulation (EU) 2017/745
EU framework governing the placing on the market and conformity of medical devices. A targeted MDR/IVDR simplification revision (COM(2025) 1023) is before Parliament and Council. The legacy-device dates below, marked conditional, apply only to devices that meet the conditions of Art. 120(3c) MDR as amended by Reg (EU) 2023/607.
- : Signed by Parliament and Council Source
- : Date of application Source
- : Targeted MDR/IVDR simplification proposed (COM(2025) 1023) Source
- : First four modules of the European database on medical devices (EUDAMED) mandatory (Reg (EU) 2024/1860) Source
- : Legacy transition ends for class III and class IIb implantable devices, except listed IIb implants such as screws and plates (conditional) Source
- : Legacy transition ends for other class IIb, class IIa, Is and Im devices, and for self-declared devices that now need a notified body (conditional) Source
- EU MDR Compliance for Swiss MedTech: The Dual-Track Reality
- EU Authorized Representatives for Swiss Manufacturers Under the MDR and IVDR
- Clinical Evidence for SaMD: What Swiss and EU Regulators Actually Expect
- Post-Market Surveillance for SaMD: When Software Keeps Changing