We expect the primary impact of the reclassification for consumers will be a greater level of quality for Active Medical Devices in terms of reliability, safety and effectiveness. By putting these medical devices into a higher class they will undergo more rigorous assessment prior to becoming available to consumers, decreasing the risk to consumer health of the devices not functioning as intended.
The CHF acknowledges that there is potential for a delay in accessibility for critical medical devices should certain devices be reclassified into a higher Class. However we believe that it is crucial that any such critical devices be rigorously assessed for safety, efficacy and quality before being made available to ensure faulty or ineffective devices are not given to consumers. Additionally we believe the proposed transitional arrangements should give manufacturers and sponsors sufficient time to ensure their devices are assessed appropriately and are able to be made available to consumers when the new classification applies.