To Ensure Continued Availability Of Self-Care Devices In Europe, EU Commission Must 'Stop The Clock' On MDR
Executive Summary
As the implementation deadline for the European Union's Medical Devices Regulation creeps ever closer, substance-based medical devices such as nasal sprays and throat lozenges are in danger of slipping through the net of re-certification. TÜV SÜD, one of only four notified bodies to be approved for re-certification under the new rules, says the EU should "stop the clock" on implementation to ensure these products continue to be available in Europe after the deadline.