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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.
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.
We need to forge alliances to continue our global health leadership, writes the director of the Independent Commission on UK-EU Relations.
CE marking recognition extended “indefinitely” for certain products – what does the future hold for UKCA marking?
17/08/2023
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.
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.
Adoption of Britain-only rival to EU’s CE designation postponed ‘indefinitely’, say ministers.
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.
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.
The NHS and Brexit: What We Now Know
05/01/2023
Sam Bright examines the contribution of Brexit to our current healthcare crisis.
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 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.
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?
The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed its first certification body since the UK left the EU
03/10/2022
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.
The Brexit predictions that came true, those that didn’t—and what we didn’t see coming - BMJ
03/08/2022
Six years after the referendum we can disentangle the evidence and judge the effects on health and care, says Richard Vize.
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.
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.'
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.
Post-Brexit issues for the NHS
19/01/2022
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.
Nuffield Trust: Slow decisions and vague trade slogans leave NHS uncertain of post-Brexit future
20/12/2021
Our report published today looks at six key areas of health and social care that are being impacted by Brexit.
There are supply issues with medical devices, fuel and food costs.
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.
The prime minister has imperilled peace in Northern Ireland, and every day the economic fallout worsens.