Medical devices illustrate the limited scope for post-Brexit UK divergence from EU rules, and the trade-offs the UK must face. / 'Many manufacturers have suggested they will not bother with the additional cost and complexity of putting their devices through the UKCA processes on top of the updated European process.'

With it still possible the United Kingdom will leave the European Union without a deal, Mark Dayan looks at the impact that would have on NHS costs.

The prime minister has imperilled peace in Northern Ireland, and every day the economic fallout worsens.

Makers and suppliers of life-saving drugs and medical devices say they have still not been told by British authorities how their goods will be handled if the UK leaves the European Union without a deal at the end of October.

The UK left the EU on January 31, 2020, and this began the complex process of de-coupling the UK regulatory regime from that of the EU. This has not been straightforward, particularly where goods move into and out of Northern Ireland (NI), where the EU rules continue to apply, from Great Britain (England, Wales, and Scotland (GB)), where they do not.

On 1 August 2023, the UK Government announced an “indefinite” extension to the recognition of CE marking for certain products placed on the market in Great Britain.

Brexit could have major implications for health and social care in England. Here we look at some of the latest developments that could have an impact.

THE SEISMIC CHANGES to the relationship with our nearest neighbours and the impact of Brexit have only added fuel to the fire of severe challenges facing health and social care in the UK today, making people less healthy and widening health inequalities.

From 1 January 2021, the medical device regulatory landscape in the UK changed. The regulatory structure for medical devices is very complicated and fragmented. / Listed below are the old and new medical device regulations in EU and the UK, as identified by GlobalData.

For new medical devices entering the UK market, they will only need to comply with the old, and for some, less stringent, device standard (MDR, 2002). / ... Coupled with the additional authorisation process required to reach the UK market, this may lead to delays or deter companies from selling their products in the UK altogether.

Brexit comes with uncertainty regarding the approval of medicines and medical devices, including software and technology. Regulatory hurdles could disrupt the approval of existing and new devices and technology.

Brexit shut off the “relief valve” of immigration from the European Union, worsening workforce shortages in health and social care in the UK, a report from the Nuffield Trust think tank has concluded. / Brexit’s effect has been felt particularly in specialties such as cardiothoracic surgery and anaesthesia, and in dentistry and the care sector.

Health Minister Robin Swann has voiced concern about the supply line of medicines to Northern Ireland as a result of a looming Brexit regulatory barrier.

UK drug distributors and those involved in the parallel importing of drugs have told the parliamentary Health Select Committee that they want to see the UK remain in the customs union and the single market.

Are you a quality manager for a small medical device start-up looking to expand into global markets? Or maybe you are a seasoned device manufacturer preparing to once again traverse quality regulations to deliver a new product to the European market?