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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?
Criminals selling counterfeit drugs prey on the vulnerable. The threat of no deal may make anxious patients turn to them.
A new video by Peter Stefanovic rubbished Johnson's claim that the vaccine rollout's success was down to Brexit.
Boris Johnson has faced the wrath of social media for posting a video banging on about Brexit.
On the third anniversary of Brexit, Boris Johnson has attempted to paint the withdrawal from the EU as a major boost for the UK – but immediately faced pushback over a questionable claim.
Helmuth Porschen ponders the fate of UKCA and wonders why the government can’t persuade the rest of the world to adopt British standards.
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.
BREXIT is causing “damage across the board” to UK science, including missing out on more than £1 billion in funding, campaigners have warned.
As of December 2022, UK companies importing medicines from the EU may need to set up new batch testing facilities. What will this mean for the industry and how did the situation come about?
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.
And it will cost more here because of the UK pulling out of the European Medicines Agency on 30 December.
There are growing post-Brexit differences between which medicines are approved for use in Northern Ireland and the rest of the UK, research from a health think tank indicates.
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.
US, European, Japanese and Chinese patients could get novel medicines ahead of patients in the UK after Brexit, the CEO of French pharma Ipsen has said in an interview.
Britain’s medicines regulator has contradicted claims by health secretary Matt Hancock that the UK got the first coronavirus vaccine faster because of Brexit.
Preparedness and vaccine rollout outside of EU under scrutiny as inquiry kicks off.
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.
David Meek, the CEO of Ipsen, warns Britain leaving the European Union has seen the country fall down the list of priorities.
Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions.
Education secretary lauds vaccine rollout saying scientists in UK better than in France, Belgium or US.
A House of Lords committee will discuss the impact of the Northern Ireland protocol on medicine supplies in Northern Ireland.
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.
Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed.
This being 2020, it didn't take long for good news about the Pfizer/BioNTech jab to turn into a tiresome row about 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.
Kate Bingham contradicts Matt Hancock's claim UK authorities backed jabs swiftly "because of Brexit".
The government and its supporters are beginning to claim 'benefits' of being outside the European Union some of which were always available to EU member states or, in other cases, are not benefits at all.
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 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.
Britain must work with other countries to prevent friction on medicine rules post-Brexit to avoid being sidelined by the global drug industry, according to a report from the U.K.’s biggest pharmaceutical lobby group.
The UK’s medicines and devices regulator will stop work that “does not add value” and lose over 100 full time equivalent staff posts as part of its post-Brexit cost cutting drive, a leaked consultation document seen by The BMJ shows. / But experts warned that plans to streamline regulation to speed up the development and approval of new drugs for patients’ benefit carried potential safety risks.
As obvious as it is to see the decline in the number of clinical trials in the UK, the reasons behind this trend are as complicated to ascertain. Fiona Maini, Principal - Global Compliance and Strategy at Medidata Solutions, thinks the issue is multifaced with Brexit playing a part in this.
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.
The UK’s MHRA may have to lay off about 300 of its 1,200 employees, thanks to a decline in income due to reduced medical product submissions following Brexit, spurring anger among unions across the island.
Health Secretary Matt Hancock has claimed Brexit allowed the UK to approve a Covid vaccine more quickly than other European Union (EU) countries.

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