MHRA appoints first new UK Approved Body to certify medical devices since Brexit

Press release

DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies, increasing the UK’s capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public.

DEKRA has become the first organisation to complete the new designation process that any potential organisation must now go through in order to become approved to certify medical devices in the UK. They are now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation).

An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.

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.

Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market.

Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer said:

This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

Approved Bodies play a critical role in the supply of medical devices and expanding capacity is vital to the successful development of the UK’s medical device regulatory regime. This has been a significant piece of work and our teams have worked extremely hard to get to this stage.

The MHRA’s detailed assessment process is designed to ensure that any organisations that wish to certify medical devices are stable, are able to undertake impartial and objective assessments, have an appropriate quality management system in place to support them, have the resources to undertake the assessments, and the processes and ongoing certification in place to meet the relevant regulatory requirements.

There are a further six organisations who are currently in the assessment process and there is active engagement with several further organisations who are preparing to submit their initial submission.

Find out more

Medical Devices: UK approved bodies

Notes to editors

  • DEKRA Certification UK Ltd has joined the current three Approved Bodies: BSI Assurance UK Ltd, SGS United Kingdom Ltd and UL International Ltd.
  • Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The proposals, alongside the consultation response and Government response have been published.

Published 29 September 2022



Fishing industry in 2021 statistics published

The publication is a summary of:

  • The UK fishing fleet
  • Its activity at sea
  • Landings – how much fish they catch and land
  • Effort – how long they spend at sea
  • Trade

Fleet

In 2021 there were 5,783 United Kingdom registered fishing vessels. This represents a 10 per cent reduction in the last ten years, however Gross Tonnage (GT) has remained the same at 202 thousand tonnes. Approximately 20 per cent of the United Kingdom fleet is represented by vessels over 10 metres in length, of which 44 per cent are administered in Scotland. There are around 11 thousand fishers working on United Kingdom registered vessels. This is a reduction of 1,700 fishers in the last ten years.

Landings

In 2021, United Kingdom vessels landed 652 thousand tonnes of sea fish with a value of £921 million. Compared to 2020, this is an increase of 5 per cent and 11 per cent in quantity and value respectively. This is mainly driven by the United Kingdom’s recovery from the covid period and additional quota available to the United Kingdom fleet after leaving the EU. Landings into the United Kingdom by foreign vessels in 2021 was 20 thousand tonnes, which compared to 2020 represents a 48 per cent reduction, however landings abroad by United Kingdom vessels has increased by 5 per cent to 258 thousand tonnes.

Trade

The United Kingdom is a net importer of fish. The United Kingdom’s crude trade gap in 2021 for sea fish is 305 thousand tonnes. This is higher than 2020 where the gap was 250 thousand tonnes. In 2021 the United Kingdom imported 655 thousand tonnes of sea fish, with a value of £3.1 billion. It exported 350 thousand tonnes, with a value of £1.6 billion.

View the full report, tables and underlying datasets at: https://www.gov.uk/government/collections/uk-sea-fisheries-annual-statistics

Notes to editors:

The Marine Management Organisation (MMO) manages the seas around England, including the management of fisheries.

The MMO has the task of ensuring that stocks are managed throughout the year to maximise fishing opportunities for the UK industry, while ensuring that stocks are not overfished and the UK government and taxpayer does not have to pay steep penalties.

We are continually working with the fishing industry to improve day-to-day management with accurate catch limits and forecasts that secure longer fisheries, while safeguarding the welfare of fish stocks.

Further information is available from our website at www.gov.uk/mmo

Contacts: Tel: 0300 123 1032
Email: media@marinemanagement.org.uk



Over £100k in charitable donations to be recovered for Wrexham charities after judge orders ex-trustee to pay out

Press release

As a result of successful legal action brought by the Charity Commission, over £117k will be recovered and distributed to support cancer patients in Wrexham and District Hospitals.

The High Court of Justice has ruled in favour of the Charity Commission following its decision to take legal action for restitution against the sole trustee of the Frank Wingett Cancer Relief Fund.

Simon Wingett has been ordered to repay £117,100.32 which, subject to recovery, will be distributed by the Commission to local charities supporting the relief of cancer patients treated in Wrexham.

This follows a compliance case into the Frank Wingett Cancer Relief Fund, which the regulator opened in 2017 to investigate concerns about the charity’s management.

The charity was set up to relieve patients in Wrexham and District hospitals, particularly those suffering from cancer and allied diseases, through raising funds for medical and surgical equipment and facilities.

The charity came under scrutiny after its funds were misused to support the creation of a 210ft (over 60m) Welsh dragon statue as a tourist attraction. This project has no connection to advancing the charity’s aims and to date, no statue has been built.

In July 2019, the Commission disqualified Mr Wingett from acting as a trustee or senior manager of any charity in England or Wales for a period of 10 years and has since pursued the restitution of funds.

Tracy Howarth, Assistant Director of Casework at the Charity Commission, said:

Charity trustees hold important positions of trust. We – and the public – expect trustees to ensure financial decisions are taken in the best interests of the charity and those it serves to benefit.

Mr Wingett’s significant misuse of funds was an abuse of the trust placed in him by the many donors to the charity. This ruling will ensure the charitable proceeds raised are now directed to the benefit of those in the local community they were intended for.

Notes to editor:

  1. On the 12th September 2022, the High Court of Justice ordered Mr Wingett to pay a sum of £117,100.32 by way of restitution. Mr Wingett has also been ordered to pay the sum of £9,755.00 to cover the Charity Commission’s legal costs.
  2. The Official Custodian will oversee the recovery of funds which can then be distributed by the Charity Commission.
  3. The Charity Commission takes cases of misconduct or wrongdoing which result in depriving a charity of property or funds very seriously. In appropriate cases and exceptionally, the commission will bring legal proceedings, in the public interest with the Attorney General’s consent, to recover funds lost to charity.
  4. For further information on the Charity Commission’s policy on restitution and recovery of charitable funds, please see this link: Charity Commission policy on restitution and the recovery of charitable funds misappropriated or lost to charity in breach of trust – GOV.UK (www.gov.uk)
  5. Any member of the public can look up any active or inactive charity based in England and Wales via our Charities Register. About the register of charities (charitycommission.gov.uk)

Published 29 September 2022



Foreign Secretary visits Singapore

Foreign Secretary Rt Hon James Cleverly MP is in Singapore today (29 September), for the first time since taking up the role, to underscore the UK’s partnership with Singapore, ASEAN and the Indo-Pacific region.

The Foreign Secretary will meet the Prime Minister, Deputy Prime Minister and his Singaporean counterpart, Foreign Minister Dr Vivian Balakrishnan, to launch a regional investment initiative and give a keynote speech on the UK’s approach to the Indo-Pacific.

Speaking from Singapore, Foreign Secretary James Cleverly said:

The links between the UK and Singapore are founded on our shared beliefs in free trade and international law and our strong commitment to the rules-based multilateral system.

Singapore is an important and strategic partner as well as a global, economic and political hub. I look forward to strengthening this partnership, working together to solve global challenges and creating sustainable prosperity in the UK, Singapore and the Indo-Pacific.

The Foreign Secretary will meet Prime Minister Lee Hsien Loong to reaffirm the UK’s commitment to stronger bilateral ties with Singapore and discuss future cooperation on regional trade and security.

At the Milken Institute Asia Summit, the Foreign Secretary will deliver a speech outlining the UK’s outlook on the Indo-Pacific region.

The Foreign Secretary will meet Minister for Foreign Affairs Vivian Balakrishnan and outline the UK’s ambition to elevate the UK-Singapore relationship, reflecting the breadth and depth of shared interests. He will sign a MoU committing the UK and Singapore to work together on capacity and resilience building in the region.

He will meet Deputy Prime Minister Lawrence Wong and launch the new British Investment International (BII) Office, which will be at the core of the UK’s development finance institution’s Indo-Pacific expansion, recognising Singapore’s role as a global financial centre. BII’s plans to invest in green infrastructure will support climate resilience and a green economic transition in the region and bring us closer to Vietnam, Indonesia, Philippines, Cambodia and Laos.

Srini Nagarajan, Managing Director and Head of Asia, British International Investment said:

Our new Singapore office is a momentous step in BII’s history, which will play a significant role in our Indo-Pacific expansion and bring us closer to our focus markets of the Philippines, Indonesia, Vietnam, Cambodia and Laos. We will invest in the renewables sector and partner with a network of investors to help these economies reduce emissions, protect the environment and adapt to the changing climate.

The Singapore visit will conclude his three-day visit to East Asia, during which the Foreign Secretary highlighted the UK’s deep interest in the Indo-Pacific region and took forward shared ambitions on trade and security.



UK marks World Maritime Day with £60 million boost for clean shipping

  • government launches £60 million clean maritime competition on World Maritime Day
  • zero-emission vessels, fuels and clean port infrastructure set to benefit from funding and boost economic growth
  • announcement made during Transport Secretary keynote address to Atlantic Future Forum in New York

Tankers, cruise ships, ports and the wider maritime sector could play their part in slashing emissions and boosting economic growth thanks to £60 million of funding for the UK maritime industry.

To mark this year’s World Maritime Day (29 September 2022), Transport Secretary Anne-Marie Trevelyan is announcing funding for the third round of the clean maritime demonstration competition (CMDC), which will run from April 2023 to March 2025 and help innovative companies and scientists make emission-free maritime a reality. 

The Transport Secretary will make the announcement during a keynote address to the Atlantic Future Forum in New York, on the HMS Queen Elizabeth.

The address will focus on how maritime security improves global prosperity and protects all of our interests, as well as how more environmentally-friendly shipping can lead to a sustainable future for maritime trade.

From today, UK companies will be able to bid for a slice of the funding to supercharge the development of early-stage clean maritime technologies for wider use in the future.

This is all part of government plans to back innovative businesses and reach net zero emissions by 2050.

Transport Secretary Anne-Marie Trevelyan said:  

The UK has always been a proud seafaring nation and helping the maritime sector to be more environmentally-friendly will mean it continues to play a key role in the UK’s economy for generations to come.

This World Maritime Day we’re announcing funding to harness the best innovations the UK has to offer – proving that tackling climate change can go hand-in-hand with business innovation, job creation and supercharging economic growth.

In 2020 UK domestic maritime vessels contributed around 5% of the UK’s domestic greenhouse gas emissions – more than trains and buses combined.

The CMDC is one of the ways the government is supporting the sector to decarbonise.

Also announced today are the winning projects from the second round of the CMDC, launched in May 2022, which saw £12 million shared between 121 UK companies.

Among the winners are 3 projects exploring the development of green shipping corridors – zero emission shipping routes between 2 ports. These routes build on the Clydebank declaration backed by 24 states at COP26.

The Clean Tyne Shipping Corridor consortium, the Aberdeen Harbour Board and ACUA Ocean hydrogen-powered North Sea crossing study, and the (GCSS) study between the Port of Dover and the Ports of Calais and Dunkirk, aim to support the transition to green crossings to and from the UK. This could one day create international agreements that would see only zero emission vessels – including ferries, leisure crafts and workboats – between the UK and other ports.

Using aerospace technologies, new ships are being developed that ‘fly’ above the surface of the water, reducing operational emissions by 100% and fuel costs by up to 90% by reducing drag. Built in Belfast by Artemis Technologies in collaboration with Tidal Transit, ORE Catapult and Lloyd’s Register is a project receiving over £1 million to develop a green, 24-metre workboat to transfer workers to and from offshore wind farms.

David Tyler, Commercial Director at Artemis Technology said:

Following years of underinvestment in research and innovation by the maritime industry, the sector is under real pressure to develop and adopt disruptive technologies if it has any chance of achieving the UK’s ambitious net zero targets.

The clean maritime demonstration competition is welcomed by the sector and will play a critical role in helping accelerate the UK’s transition to a more sustainable maritime future.

Today’s announcement follows the allocation of £206 million to support zero emission sailing and skilled maritime jobs as part of UK SHORE, announced in March this year.

The UK Shipping Office for Reducing Emissions (UK SHORE) is housed in the Department for Transport and is dedicated to creating a world free from shipping emissions.

UK SHORE is implementing a comprehensive research and development programme, including the CMDC, working in partnership with industry to help build greener vessels – from cruises to tankers and leisure boats.

Innovate UK Executive Director for Net Zero, Mike Biddle, said:

The maritime sector is of crucial importance to the UK, with more than 95% of our trade running through the major ports that connect us to the global economy.

As such an important part of the UK economy, significant change is needed to ensure that the sector adapts to new, clean technologies, reducing maritime emissions.

This latest, multi-year round of the government’s clean maritime demonstration competition builds on the success of the first 2 rounds, stimulating innovation to ensure the UK is at the forefront of this transition to make maritime greener.

Ashley Feldman, Programme Manager for Transport and Smart Cities, techUK said:

Today’s announcement marks an important step forward in the UK’s journey to net zero. The maritime sector is especially complex to decarbonise and the CMDC is funding cutting-edge innovation for solving these challenges.

This next round of investment will accelerate progress, ensuring the UK emerges as a global power for these technologies.

Ben Murray, CEO of Maritime UK, said:

The maritime sector is one of Britain’s biggest industries and can play a major role in helping to grow our economy as we accelerate efforts to decarbonise the sector, delivering well-paid, high-quality jobs across the UK. > This funding will help all parts of the sector to develop the solutions needed for maritime decarbonisation. 

Industry is rising to the challenge and co-investing with government to accelerate progress on clean maritime propulsion and infrastructure.

 If we move quickly, the UK has a generational opportunity to lead globally, exporting cutting-edge solutions to maritime businesses across the world.