Patient safety must prevail
Alarming messages in the international media yesterday and today confirm the need to ensure that patient safety is at the heart of the EU Medical Devices Regulation. At different moments before the new regulatory framework came into force in May 2017, AIM has been asking for high risk medical devices to go through a similar approval process as currently exists for pharmaceuticals. Only on that basis we can protect patients from defective and dangerous products. Medical devices should be tested and approved in accordance with uniform criteria, and only by one European approval authority, for example the European Medicines Agency (EMA). In one of our press releases, published in June 2015, we stated that the current authorization procedure by private, so-called “notified bodies” is by far not sufficient to eliminate the main problems in the current approval of high-risk medical devices. Please find that press release here.