Medical technology manufacturers fully support the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which aim to “establish robust, transparent, predictable and sustainable regulatory frameworks for medical devices which ensure a high level of safety and health whilst supporting innovation”. However to date, these objectives have not been fully met. The availability of medical technologies – both IVDs and medical devices – to patients in Europe is at stake and therefore broad and comprehensive reforms are needed in the short- and mid-term to support public health, patient safety, and the future sustainability of Europe’s health systems.
Positions
Technical Regulatory Affairs
Medical Technology Industry stands ready to support work on the future of the Medical Technology Frameworks
The availability of medical technologies – both IVDs and medical devices – to patients in Europe is at stake and therefore broad and comprehensive reforms are needed in the short- and mid-term to support public health, patient safety, and the future sustainability of Europe’s health systems.