During a pre-flight brief for a SAR training flight, the co-pilot highlighted that a previous flight on the aircraft resulted in unexpected pitch oscillations following the selection of the Transition Down mode of the Automatic Flight Control System (AFCS). After other training priorities had been completed, the crew replicated the circumstances that triggered the previous pitch oscillations. The result was similar unexpected flight oscillations in the pitch axis and the crew reported this to the operator.

The event was caused by a shortcoming in the design of the Phase 5 version of the AFCS software SAR upper modes – this also resulted in the incorrect AFCS mode indications being shown to the flight crew and the conflict between airspeed and groundspeed priority on selection of the Transition Down.

Safety Action has been taken by the manufacturer and operator to address the shortcomings in the software, to brief the helicopter community and reinforce the importance of reporting issues.

Read the report.

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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.

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)