European doctors ask European Commission to ensure availability of medical devices in Europe
European doctors are concerned about the availability of many medical devices on the European market. An internal survey showed that doctors are already struggling with shortages that could become much more serious in the near future.
One of the main reasons for these disturbances is the slow implementation of the Medical Devices Regulation (MDR) 2017/745 and the limited capacity, or even lack, of notified bodies.
This situation is unacceptable for patient safety and quality of care. For European doctors, medical devices are indispensable tools for the effective provision of safe and evidence-based patient care.
If no other solution to increase the capacity of Notified Bodies and to make economic operators comply with MDR rules can be found, legislative steps must be considered. This includes permitting continued use, beyond what is currently foreseen in the Regulation, of selected classes of medical devices which do not present unacceptable health risks under the Council Directives 90/385/EEC and 93/42/EEC certificates. This may be permitted for a limited period of time until the MDR certification is processed.
At the same time, recognising that high risk and invasive devices should remain subject to the more stringent certification foreseen by the new Regulation, a blanket extension for all classes should be avoided.