Angela Carney

From the Parliamentary 
Under Secretary of State 

Great Minster House 
33 Horseferry Road 
London 
SW1P 4DR 

Tel: 0300 330 3000 
E-Mail: 

Web site: www.gov.uk/dft 

Our Ref: 

      20 March 2025 

M D Fleming 
H M Senior Coroner 
H M Coroner’s Court 
Cater Building 
1 Cater Street 
Bradford 
BD1 5AS 

Dear Mr Fleming, 

Thank you for your report of 13 January made under the Coroners and 
Justice Act 2009 and the Coroners (Investigations) Regulations 2013, 
following the inquest you conducted into the death of Angela Carney. I am 
responding as Minister for the Future of Roads. 

I was saddened to hear of Ms Carney’s death and offer my sincere 
condolences to her family and friends. 

The regulatory requirements for the construction of mobility scooters is the 
responsibility of the Medicines and Healthcare products Regulatory Agency 
(MHRA). The Department for Transport (DfT) has responsibility for the use of 
these vehicles in the built environment, and the relevant regulations are The 
Use of Invalid Carriages on Highways Regulations 1988. 

The DfT regulations specify the circumstances where mobility scooters may 
be used and contain provisions on the performance requirements these 
vehicles need to meet. Regulation 8 requires braking systems to be 
maintained, to be able to bring the mobility scooter to rest in all conditions of 
use, and capable of holding it stationary on a one in five gradient. The 
regulations permit a transmission brake which operates on the electric motor, 
and from the information available to us, the mobility scooter was compliant 
with the 1988 Regulations.  

I am aware that the MHRA has also been asked to consider this case, and 
that they have provided a response which sets out the changes to the 
standard in 2009 and 2022. These changes should ensure that the scooter 
has effective brakes when it is in freewheel mode. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Officials in my Department will continue to liaise with the MHRA to establish 
whether anything further can be done to prevent such a tragic death 
happening in future; for example, by providing information to mobility scooter 
users highlighting the risks of operating in freewheel model and warning 
users about the absence of a secondary brake on older models of scooter. 

Best wishes, 

MINISTER FOR THE FUTURE OF ROADS

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Mr Martin D Fleming 
His Majesty’s Senior Coroner for West Yorkshire  
By Email: 

Reference: 

13 February 2025 

Dear Mr Fleming, 

Regulation 28 report relating to the death of Angela Stacey Carney (DOD 26/09/2023) 

Thank you for your Regulation 28 report relating to the death of  Ms Angela Stacey Carney 
(DOD 26/09/2023) which was received on 13 January 2025. I would like to offer my sincere 
condolences to Ms Carney’s family on their tragic loss.  

I am writing in relation to your request that the Medicines and Healthcare products Regulatory 
Agency (MHRA) takes action to prevent similar events of this kind occurring in the  future. I 
have provided some background information below, which I hope will offer some useful context 
regarding our role, followed by our response to your matters of concern. 

Introduction and regulation of medical devices in the UK 

The  MHRA  is  an  executive  agency  of  the  Department  of  Health  and  Social  Care  and  is 
responsible  for  the  regulation  of  medical  devices,  blood  components  for  transfusion  and 
medicinal  products  in  the  UK.  We  take  all  reasonable  steps  to  protect  public  health  and 
safeguard  the  interests  of  patients,  public  and  users.  We  ensure  manufacturers of  medical 
devices comply with the UK Medical Devices Regulations 2002, as amended, to demonstrate 
that they meet appropriate standards of safety, quality, and performance prior to placing new 
medical devices on the market and during the intended service life of the device.  

While the MHRA does not regulate the sale of second-hand medical devices, where possible, 
we work with a range of stakeholders including patients and the public to work towards the 
promotion of safer medical devices and their safe use. 

 
 
 
 
 
 
 
 
 Manufacturers must demonstrate compliance with the Regulations before a medical device 
can be UKCA or CE marked and placed on the UK market. Although not mandatory, device 
manufacturers can use designated standards to demonstrate that their devices are compliant 
with relevant requirements of the Regulations. Manufacturers of wheelchairs and scooters can 
self-certify compliance with the regulations as these are Class I medical devices. 

As  part  of  the  requirements,  manufacturers  must  identify  potential  hazards  and  risks 
associated with use of their device and establish mitigations for each of the identified risks, 
this is an ongoing process throughout the lifecycle of any medical device. The risk mitigations 
related  to  use  of  the  device  can  include  but  are  not  limited  to,  warnings  in  user  manual, 
labelling and educational material. 

One  major  area  of  the  MHRA’s  responsibilities  is  to  collect,  analyse,  monitor,  and  act  on 
information  relating  to  safety  concerns  from  a  range  of  data  sources  including  reports  of 
adverse incidents. An adverse incident is an event involving a medical device, which produces, 
or has the potential to produce unwanted effects involving the safety of patients, users, and 
other  persons.  These  effects  may  arise  from  shortcomings  in  the  device,  its  operating 
instructions,  user  practice  or  conditions  of  use.  Adverse  incidents  may  also  occur  due  to 
patient  factors,  as  not  all  interventions  are  suitable  for  all  patients  and  their  condition  may 
change over time, requiring a different approach. 

Patient safety is our highest priority, and we encourage everyone to report safety concerns to 
the MHRA through our Yellow Card scheme. Additionally, it is mandatory for manufacturers of 
medical devices to report certain incidents to the MHRA. In general, where an adverse incident 
occurs, the manufacturer of a medical device is responsible for carrying out any investigation 
required  and  informing  the  MHRA  of  their  findings  directly  or  through  the  appointed  UK 
Responsible Person. We regularly review our database of incidents to detect safety signals 
and  consider  whether  additional  action  is  required.  Where  necessary  we  will  issue  safety 
messages to health and care organisations, patients, and the public. These types of actions 
help to reduce the risk of similar incidents happening again. 

Synopsis of incident 

The  MHRA  was  first  informed  of  the  incident  leading  to  the  death  of  Ms  Carney  by  the 
Regulation 28 report received by the MHRA on 13 January 2025. Prior to this notification, we 
had not  received  any  information  regarding  this tragic incident.  A  search  conducted on  the 
MHRA adverse incident database did not yield any results that corresponded with the specific 
event described in the report. 

We  initiated  an  investigation  focusing  on  identification  of  the  specific  device  and  its 
manufacturer. Following the provision of additional information by the Coroner’s Officer, it was 
determined  that  the  device  involved  in  this  tragic  accident  was  Sterling  Sapphire  mobility 
scooter, manufactured by Sunrise Medical Ltd. The manufacturer initially was not aware of the 
extent of the device involvement in the accident, however, subsequently to being informed on 
the circumstances concerning the tragic accident in October 2024, the manufacturer failed to 
report it to the MHRA. Further information was provided to the MHRA by the manufacturer, 
indicating that at the time of the accident, the device was 19 years old and had a flat battery.  

 
 
 This model of  the  scooter has  a  service  life of  five  years and has been  discontinued  since 
2010. 

As indicated in the Regulation 28 report, Ms Carney purchased the scooter second hand from 
her  neighbour,  and  it  was  noted  in  the  report  that  this  model  of  the  scooter  did  not  have 
secondary (independent) braking mechanism. At the time of the tragic accident, Ms Carney’s 
mobility  scooter  was  in  freewheel  mode,  as  it  descended  a  road  with  a  4.7%  downward 
gradient. The engine was disengaged, thereby preventing the activation of the primary brakes. 
The scooter proceeded down the footpath at speed towards the junction and directly into the 
path of a vehicle. Regrettably, Ms. Carney succumbed to her severe injuries at the hospital 
following the collision. 

Matters of concern 

You have expressed the following as matters of concern: 

1)  While more recently designed and manufactured mobility scooters are manufactured with 
secondary braking system by way of a fitted hand brake mechanism, other manufacturers 
may be producing scooters without such independent braking mechanism. 

2)  There may be other second-hand mobility scooter models being used without secondary 

brakes.  

3)  Summary of the concern: To review the adequacy of the existing guidelines and regulations 
and to consider the feasibility of fitting secondary braking systems by way of a fitted hand 
brake mechanism to all mobility scooters. 

Prevalence of the problem 

A search of our database over the last five years (January 2020 – January 2025) yielded five 
potentially relevant reports involving mobility scooters and powered wheelchairs, with three of 
these  reports  having  inconclusive  link  to  the  freewheel  mode.  The  remaining  two  reports 
appear  to  have  relevance  to  the  freewheel  mode  and  reported  issues  with  functionality  of 
brakes. Notably, no injuries were reported as a result of these two events. 

Comments  

The initial concerns around the risk of unintended movement of mobility scooter in freewheel 
mode were raised by the MHRA (previously known as Medical Device Agency) in 1999. The 
Agency issued a safety notification (MDA SN1999 (15)) indicating that the manufacturers of 
mobility scooters should include appropriate warnings in the instructions for use to ensure the 
users are aware of the risks and should be advised to use the freewheel device only when it 
is essential and that it should be re-engaged as soon as manoeuvre is completed.  

Following this, changes were introduced to the next iteration of the standard ‘BS EN 12184 
Electrically  powered  wheelchairs,  scooters  and  their  chargers.  Requirements  and  test 
methods’.  The  introduced  changes  included  requirements  of  having  brakes  which,  when 
operated after the scooter has been put into freewheel mode, shall bring the device to a stop. 

 
 
 
 Actions taken in response to the matters of concern 

1.  We are working with the manufacturer of Sterling Sapphire mobility scooter to address 
the failure to report this serious incident to the MHRA in October 2024, in accordance 
with  vigilance  reporting  requirements.  To  address  this,  the  manufacturer  has  been 
requested  to  review  their  internal  processes  related  to  reportability  and  provide  the 
MHRA  with  the  outcomes  of  this  review  by  17  March  2025,  indicating  whether  any 
improvements have been implemented. 

2.  We have reviewed the current version of the standard BS EN 12184:2022 ‘Electrically 
powered  wheelchairs,  scooters  and  their  chargers’.  Requirements  and  test  methods 
and  the  following  provisions  related  to  freewheel  mode  /  device  are  included  in  the 
standard: 

•  Subclause 10.2 Braking function, 10.2.1 Requirements states the following: 10.2.1. b) 
The wheelchair shall have a running brake which, when operated after the wheelchair 
has been put into freewheel mode, shall bring the wheelchair to a stop. NOTE 1 This 
requirement can be met by a brake which operates when freewheel mode is ended, if 
that brake provides the required function. 

•  Subclause 10.2.2 Test methods, 10.2.2.1 Determination of the effectiveness of running 

brakes specifies the conditions of testing. 

•  Subclause 10.3 Freewheel device states the requirements for the freewheel, including 
the following: An audible alarm activated when the freewheel device is in operation and 
deactivated  when  the  drive  and  braking  systems  are  fully  operational  can  assist  the 
occupant  and/or  assistant.  Freewheel  devices  shall  be  protected  against  activation 
caused by accidental contact. Example: A suitable shape and location for the means 
for disengagement. 

•  Subclause 12.6 Emergency stop states the following: The wheelchair shall be fitted with 
one  or  more  emergency  stop  devices  to  enable  actual  or  impending  danger  to  be 
averted. 

The emergency stop function shall be available and operational at all times, regardless 
of  the  operating  mode.  Emergency  stop  devices  shall  be  a  back-up  to  other 
safeguarding measures and not a substitute for them. 

•  Annex B, Recommended design features, subclause B.3.4 Freewheel alarm indicates: 
When the freewheel device is operated, an auditory warning and/or a visual warning 
should be made until the freewheel device is deactivated, and the drive and braking 
system is fully operational. 

 
 
 
 
 
 •  Annex  E,  Recommendations  for  safety  in  freewheel  mode,  subclause  E1  provides 
recommendations  to  limit  the  speed  of  the  device  and  to  allow  safe  re-engagement 
following the manually re-engaging the drive and / brakes to exit freewheel mode. 

•  Subclause E.2 indicating the following recommendation: When in freewheel mode, the 
wheelchair should be prevented from travelling faster than 0,5 m/s on the rated slope. 

in 

for  mobility  scooters  when 

The provisions listed in the BS EN 12184:2022 standard comprehensively outline safety 
requirements 
freewheel  mode,  with  additional 
recommendations  for  the  manufacturer  to  limit  the  speed  of  the  scooter  when  in 
freewheel  mode.  BS  EN  12184:2022  is  a  harmonised  standard  in  the  EU.  The 
requirements for brakes that enable the device to stop once in freewheel mode were 
also  reflected  in  BS  EN  12184:2009,  which  is  the  designated  standard  in  the  UK. 
Designated  standards  (harmonised  in  the  EU)  can  help  manufacturers  demonstrate 
their products, services or processes comply with the relevant regulations. By following 
designated standards for UKCA marking (or harmonised standards for CE marking), 
manufacturers  can  claim,  ‘presumption  of  conformity’  with  the  corresponding 
requirement.  

3.  Using the data from our Registration Database, we have identified manufacturers who 
have registered with the MHRA as manufacturers of powered mobility scooters. We will 
sample  a  number  of  these  manufacturers  to  evaluate  the  extent  to  which  mobility 
scooters placed on the market in the UK are equipped with adequate safety features to 
mitigate the risk of unintended and uncontrolled movement while in freewheel mode. 
Following  this  initial  review  and  based  on  its  findings,  we  will  undertake  appropriate 
regulatory actions. 

4.  We  are  aware  of  complexities  associated  with  the  use  and  purchase  of  mobility 
scooters, including the use of devices beyond their intended service life, purchase of 
second-hand devices from unauthorised retailers, and use of devices that are not safe. 
In addition to the existing guidance on the safe use of assistive technology devices1, 
the MHRA is working on updating Medical devices: information for users and patients 
guidance to raise awareness on important considerations prior to purchasing a mobility 
scooter. The updated guidance will include key points for potential users to be aware 
of before purchasing their mobility scooter, including links to documents produced from 
other  organisations  to  further  strengthen  the  advice.  The  update  is  expected  to  be 
published by June 2025. We will inform you once the guidance is updated.  

5.  To  further  promote  the  guidance,  once  published,  we  will  collaborate  with  relevant 
stakeholders to disseminate this information and emphasize the importance of safety 
features in mobility scooters when operating in freewheel mode. 

Conclusions 

While we have received a relatively low number of reports potentially related to braking issues 
when in freewheel mode, we acknowledge the severity of harm that can occur if the device is 
not  equipped  with  appropriate  stopping  mechanisms.  We  will  therefore  take  the  necessary 
steps to try and address the concerns raised.  We will continue to monitor reports concerning 

1 Assistive technology: definitions, examples and safe use - GOV.UK 

 
 
 
 
 braking  mechanisms  in  mobility  scooters  when  in  freewheel  mode,  work  on  analysing  any 
emerging safety patterns and act on identified safety signals.  

Should you have any further questions, please do not hesitate to contact my office: 

Yours sincerely 

Chief Executive  
Medicines and Healthcare products Regulatory Agency 
E: