The pan-European industry association for medical technology manufacturers, MedTech Europe, has developed and published an infographic to bring attention to its ‘Urgent call for action’ to European legislators to support high-level solutions to the delays, bottlenecks and other problems that have beset the introduction of the new Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746).
The Introduction to the Infographic states: “Europe is facing the imminent threat of shortages of medical devices needed by hospitals and physicians to care for patients. This situation is critical and affects both new and existing devices. Immediate and urgent action by the EU institutions is needed.” Some of the obstacles to a smooth implementation of the new regulations, threatening the availability of medical devices in Europe, are then highlighted, including:
MedTech Europe proposes several possible legally binding solutions which would help ease access to safe medicala devices, including:
The final message from the Infographic is: “MedTech Europe urgently calls on legislators to support the adoption of bold EU-level legislative solutions that help ensure patients and health systems have access to all categories of medical devices.”