- An alliance of 36 biomedical societies has backed extending the Medical Device Regulation recertification deadline to avert a “looming crisis.”
- The consortium, the Biomedical Alliance in Europe, learned that half of polled clinicians already have found some medical devices are no longer available, and fears the situation will get worse as more certificates issued under the old directives expire.
- In response, the alliance aims for authorities to take a range of actions including pushing back the recertification deadline to “rectify issues that inhibit full implementation of the MDR” such as the shortage of notified body capacity.
The deadline for MDR certification is now less than 18 months away. By May 26, 2024, all medical devices that are currently certified under the old directives must be re-certified. The latest European Union survey found 23,000 devices need to be re-certified or be withdrawn. With 17,000 certificates set to expire in 2024, notified body capacity constraints may mean some devices will need to be pulled from the market.
The alliance, which represents 400,000 researchers and health professionals at bodies such as the European Society of Cardiology, has concluded that officials need to act to avert a crisis.
Provided standards for clinical evidence are maintained, the alliance said it will support the extension of the May 2024 MDR certification deadline. The organization framed the delay as buying policy makers time to address notified body capacity concerns and establish a special framework for orphan medical devices.
The framework proposal reflects the alliance’s concerns about devices that are used in small populations of patients, such as those designed for children or that target rare diseases. If MDR increases costs, such devices may become less financially attractive. Alan Fraser, chairman of the alliance’s regulatory affairs committee, said he sees a role for medical societies in supporting the manufacturers of such devices.
“Manufacturers of devices that are used infrequently need to acknowledge their social responsibilities to patients, and apply the pathways that are proposed for keeping legacy products on the market. Medical societies can support these initiatives by providing data from registries on the clinical performance of existing devices,” Fraser said in a statement.