RQM+ Medical Device and In Vitro Diagnostics Blog

The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also meant that the EU MDR was not implemented into UK legislation before the UK exited from the EU. The UK’s departure from the EU has now added a whole new set of regulatory requirements into the mix. Trading with the UK just got a bit more complicated!

What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge. Yet, the UK’s exit from the European Union (EU) has brought with it a whole host of new regulatory requirements that manufacturers will need to implement if they wish to continue selling their products on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued their delivery plan for the UK’s future regulatory framework and have recently launched their public consultation on the future of medical device regulation in the UK. But what do we know so far about the immediate impact on medical device regulation in the UK?