UK to mirror MDR and IVDR in event of no deal Brexit
The MHRA has reiterated guidance on how medical devices will be regulated in the event of a no deal Brexit.
As things stand, the UK is scheduled to leave the European Union on 31st October unless further legislation is passed in Parliament.
The UK will have a system in place that will mirror the new medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).
Companies manufacturing devices, active implantable medical devices, in vitro diagnostics (IVDs) and custom-made devices will be allowed grace periods of between four and 12 months to allow time for compliance with the new registration process with MHRA.
In a no deal scenario, the MHRA would take on the current responsibilities for the UK market currently undertaken by the EU system.
Device firms may have to provide the MHRA with more information to stay on the market in the UK. The MHRA will continue to perform market surveillance of medical devices on, and take decisions over the marketing and supply of devices in the UK.
The full MHRA guidance on the regulation of medical devices can be read here.