Member

As such, the amendment would impose an obligation that cannot currently be met within the existing legal framework. The establishment of a new approvals framework is not provided for by the Bill or by existing regulation-making powers in the Medicines and Medical Devices Act 2021. This would make the amendment undeliverable without such changes, which could prevent the lawful use of compliant devices. The Committee may wish to note that, operationally, this would be highly complex and time-consuming.