24
Nov
2022
Watch
Revision of the Medical Devices Regulation – how to ensure the availability of medical devices (debate)
Mr President, colleagues, I absolutely want to see the full and effective application of the Medical Device Regulation, because it is extremely important for patients and for those providing their medical care to give assurance on the safety and the effectiveness of these devices. But I do not want to see a situation develop whereby there will be a shortage – or, as some fear, an unavailability – of vital products. Doctors say that they are already struggling with shortages and they are fearful that this situation will become much more serious. The slow implementation of the medical device legislation and the limited capacity of notified bodies has led to this situation. Without urgent action, this situation will only get worse and these shortages will impact on patients and on the healthcare system. So, Commissioner, I welcome your statement today that in December you’re going to bring forward clear proposals to address this situation. I would hope that this will include proposals for a targeted legislative solution that will protect those devices that are already on the market. What we need, as well, is a targeted or tailored transition period for some devices.