The MHRA has announced that patients across Great Britain will continue to have access to medical devices and in vitro diagnostic devices (IVDs) “on a long term basis”.
In practice this means that medical devices and IVDs that are already CE marked in accordance with the EU Medical Devices Regulation and the EU In vitro Diagnostic Devices Regulation will not require an additional approval in the UK prior to their supply. In accordance with the Windsor Framework medical devices in Northern Ireland are governed by the EU rules regulating medical devices.
The current UK rules governing post-market obligations will remain the same. MHRA will continue to oversee all medical devices on the UK market, including in Northern Ireland. This responsibility governs safety monitoring processes including the Yellow Card scheme.