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?

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.'

Verdict has conducted a poll to analyse whether medical devices in the UK will continue to have a high degree of safety until all new post-Brexit regulations come into effect by 2023.

There are supply issues with medical devices, fuel and food costs.

The chief pharmaceutical officer has warned that without mitigation, the supply of medicines and medical devices into Northern Ireland would be considered a "very high risk area".

SCOTLAND'S two chief medical officers has issued a new warning of shortages to the supply of medicines in the event of a 'no deal' Brexit.

Northern Ireland’s Health Minister Robin Swann has voiced concern about the supply of medicines to the region as a result of a looming Brexit regulatory barrier to securing stock from the rest of the UK.

Importing fresh food through the port of Dover would only be the Government’s third highest priority in the event of a no-deal Brexit later this year, it has emerged.

The Nuffield Trust think tank has published a new report on the impact of Brexit on the UK’s health and care services. The ongoing monitoring work, funded by the Health Foundation, covers the impact on the NHS and social care workforce, medicine and medical devices supply and the economic cost, and reveals negative effects across these areas.

Our report published today looks at six key areas of health and social care that are being impacted by Brexit.

There are a number of measures that the UK Government must take in order to address the challenges of leaving the EU's single market.

Vaccines and blood products could be stockpiled ahead of a possible ‘no-deal’ Brexit, the health and social care secretary has confirmed.

Businesses that make sporting goods, children’s toys, jewellery and medical goods have struggled the most with the border costs imposed by the UK’s decision to leave the EU.

Six years after the referendum we can disentangle the evidence and judge the effects on health and care, says Richard Vize.

The impact of Brexit has only added fuel to the fire of severe challenges facing health and social care in the UK, warns the Nuffield Trust.

For almost 50 years, the NHS benefited from easy access to a large market, meaning it’s been first in the queue for the latest innovations. But what impact might Brexit have on medicines, medical devices and life sciences in the UK? Mark Dayan explains, in a blog that was first published in the BMJ on 26 February.

With the exception of the very lowest risk devices, manufacturers must apply to a UK approved body. Only after they have UKCA certification can their products be placed on the market in England, Wales and Scotland.

Sam Bright examines the contribution of Brexit to our current healthcare crisis.

Disruption to medical supplies at the UK border in the wake of Brexit will be ‘unavoidable’ warn experts.

The new European Union (EU) Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are due to be implemented across the EU from May 2021.

Adoption of Britain-only rival to EU’s CE designation postponed ‘indefinitely’, say ministers.

In the latest Brexit step-down, many goods will now have indefinite CE mark recognition – but MHRA keeps 2028 and 2030 cut-offs for medical devices.

Following the UK’s exit from the EU, the regulatory landscape for medical devices remains uncertain. Andrew Thompson, PhD, director of therapy research & analysis at GlobalData, explains what companies need to know.

In the wake of last week’s triggering of Article 50, marking the formal start of Brexit negotiations, and the publication of the ‘Great Reform Bill’ it is a good time to ask what the effect will be on dentistry, both NHS and private.

We need to forge alliances to continue our global health leadership, writes the director of the Independent Commission on UK-EU Relations.