MedTech Europe publishes ‘Urgent call for action’ infographic over MDR/IVDR shortcomings

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:

• Lack of notified body capacity
• SMEs finding it difficult to access notified bodies
• Fragmented MDR/IVDR implementation across Europe
• The new regulations are a disincentive to innovation in the EU
• Supply chain issues related to COVID-19 and the ware in Ukraine

MedTech Europe proposes several possible legally binding solutions which would help ease access to safe medicala devices, including:

• Extend the validity of expiring MDD/IVDD notified body certificates
• Allow conditional or temporary MDR notified body certificates
• Remove the deadline for ‘sell-off’ of MDD/IVDD compliant devices (which would be difficult, if not impossible, to police in any case)
• Allow more weight to compliance evidence from MDD/IVDD compliant devices, especially for clinical evidence
• Permit more dialogue between manufacturers and notified bodies while avoiding ‘consultation’
• Commission level coordination of any local derogations that might be EU-wide applied

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.”