Reports from clinicians, the European Commission and manufacturers have shown that there are issues around the availability of medical devices coinciding with the implementation of the Medical Devices Regulation. Many devices are at risk of being taken of the market with serious consequences for the provision of healthcare in Europe, and therefore the European Commission has recently announced that it will soon propose new measures to address this pressing issue.

Leading up to this, BioMed Alliance published an important survey on the availability of medical devices in August 2022. It assessed if clinicians experience that any devices that they normally use are no longer available on the market. The survey was developed by BioMed Alliance in cooperation with ESC and EFORT and was available until the end of September. We received 314 replies and the survey results show that clinicians are increasingly concerned about the fact that a rising number of essential devices is no longer available for use in medical care due to various reasons, and that this affects the quality of care for patients. Particularly devices in odd sizes or intended for paediatric or orphan indications were no longer available. Often manufacturers provided MDR related reasons for the non-availabilities, including lengthy certification procedures, high costs of putting the device on the market (particularly an issue for devices intended for small patient groups) and a lack of notified bodies.

BioMed Alliance used the survey results in its advocacy efforts to make sure the issue is addressed at EU level. We have discussed the issue in our Regulatory Affairs Committee, met with permanent representations, stakeholders and industry representatives and presented our survey results in the European Commission's Medical Devices Coordination Group Meetings.

Read the survey report here.

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