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.
Brexit and the red tape explosion 16/08/2023
Helmuth Porschen ponders the fate of UKCA and wonders why the government can’t persuade the rest of the world to adopt British standards.
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.
Preparedness and vaccine rollout outside of EU under scrutiny as inquiry kicks off.
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.
Lords committee to take evidence on impact of Northern Ireland protocol on medicine provision 25/01/2023
A House of Lords committee will discuss the impact of the Northern Ireland protocol on medicine supplies in Northern Ireland.
Specialisms such as dentistry have shortages and EU exit still causes issues with medicines in Northern Ireland, thinktank finds.
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.
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.
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?
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.
Fears extra expense and paperwork caused by Brexit will make Britain unattractive to global drugmakers.
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 is causing “damage across the board” to UK science, including missing out on more than £1 billion in funding, campaigners have warned.
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.
Brexit Opportunities Abound – Part 2 17/02/2022
Continuing the letter to Jacob Rees-Mogg, reminding him – he seems to need reminding – of the many new opportunities created by Brexit.
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.
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.
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 Brexit Benefit Myths 29/10/2021
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.
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.