Freedom of Information on on the design or manufacturer of the wheelchair (FOI 22/121)
Published 31 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-24-january-2022/freedom-of-information-on-on-the-design-or-manufacturer-of-the-wheelchair-foi-22121
FOI 22/121
25th January 2022
Dear,
Thank you for your email.
We want to explain our role in that we regulate medicines and medical devices, and ensure these are safe for the public to use in the UK. The following link to our website page provides information on our work.
Following national or international standards when manufacturing medical devices is optional and not always relevant. The manufacturer has to follow and justify the best specification for their product and can even develop their own specification if none is available.
We confirm that we cannot provide advice on the design or manufacturer of the wheelchair and we want to provide you with the following links for international standards which we hope is helpful.
“Custom made devices that are manufactured by healthcare establishments for use of their own patients are exempt from the UK medical devices regulations:
However the MHRA requirements for other custom made devices are outlined at: https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain. As part of this process the manufacturer would need to consider device compliance with relevant standards (https://www.gov.uk/government/publications/designated-standards-medical-devices)).”
Please note that British Standards Institution provides standards across a variety of industry sectors including medical devices and not our agency.
We would advise that you explore the possibilities for a suitable wheelchair with your healthcare provider considering the options currently available on the UK market. Your healthcare provider can suggest a type of wheelchair that can be suitable for your use. If no suitable wheelchair can be found on the market and a custom made wheelchair needs to be made, the healthcare provider can escalate it further with relevant organisations.
Our complaints procedure is at the following link of our website page:
We hope this is helpful.
Kind Regards
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PUFOI 22/121
25th January 2022
Dear,
Thank you for your email.
We want to explain our role in that we regulate medicines and medical devices, and ensure these are safe for the public to use in the UK. The following link to our website page provides information on our work.
Following national or international standards when manufacturing medical devices is optional and not always relevant. The manufacturer has to follow and justify the best specification for their product and can even develop their own specification if none is available.
We confirm that we cannot provide advice on the design or manufacturer of the wheelchair and we want to provide you with the following links for international standards which we hope is helpful.
“Custom made devices that are manufactured by healthcare establishments for use of their own patients are exempt from the UK medical devices regulations:
However the MHRA requirements for other custom made devices are outlined at: https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain. As part of this process the manufacturer would need to consider device compliance with relevant standards (https://www.gov.uk/government/publications/designated-standards-medical-devices)).”
Please note that British Standards Institution provides standards across a variety of industry sectors including medical devices and not our agency.
We would advise that you explore the possibilities for a suitable wheelchair with your healthcare provider considering the options currently available on the UK market. Your healthcare provider can suggest a type of wheelchair that can be suitable for your use. If no suitable wheelchair can be found on the market and a custom made wheelchair needs to be made, the healthcare provider can escalate it further with relevant organisations.
Our complaints procedure is at the following link of our website page:
We hope this is helpful.
Kind Regards
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU