MedTech Europe issued an MDR/IVDR statement after EPSCO meeting discussing the MDR and IVDR.
Whereas clinical evidence forms the foundation of patient and user safety, clinical is not mentioned anywhere. While supporting this statement in general, the phrase that the EU commission should act swiftly – indeed they should – and implement solutions to “Significantly reduce certification time and costs” is worrying since clinical trials to collect the evidence that the devices are safe are expensive and typically the first thing that ‘ falls outside the boat’. So lets keep our fingers crossed that any reform is indeed “safeguarding patient safety and public health”.