AXREM Problem Statement: Safety updates on non-contract Medical Devices

20 March 2023

Medical device regulations require the manufacturer to provide updates for medical devices in response to identified issues. These updates may be related to product safety or product performance and are reported to the local regulators (MHRA) as well as to affected customers.

Performing any update on a medical device requires certain conditions are met to ensure the update operates as expected and does not in itself result in an issue that could compromise the safety or performance of the device.

Please see the AXREM position Statement here:

200323 AXREM Problem Statement – Safety updates on non-contract Medical Devices