Freedom of Information request for a copy of the licence documents for CPAP machines and associated equipment (specifically, head straps, connector tubing, mask frames and mask cushions) (FOI 21/1172)
Published 26 May 2022
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FOI 21/1172
15th November 2021
Dear,
Thank you for your information request, dated 28th October where you asked for a copy of the licence documents for CPAP machines and associated equipment (specifically, head straps, connector tubing, mask frames and mask cushions).
I can confirm that we do not hold the information that you have requested.
The MHRA is the UK’s competent authority for medical devices, and therefore is responsible for protecting the public’s health and safeguarding the interests of patients and users. One major area of the MHRA Devices Division’s responsibilities is the investigation of adverse incidents involving medical devices. The MHRA does not licence medical devices for sale in the UK. For a medical device to be bought to market in the UK it must have received a valid CE certificate or UKCA mark. These certificates are issued by third party organisations known as approved bodies.
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 Medical Devices Regulations 2002.
Manufacturers can apply to any UK approved body and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.
Although the UKCA mark will be available for use in Great Britain from 1 January 2021, CE marking will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met. CE marked devices will also be accepted on the market in Great Britain until 30 June 2023.
With regards to the question relating to the time frame for the replacement of components, all components on a medical device must conform to the essential requirements detailed in annex 1 of the Medical Devices Regulations 2002. These detail the essential performance requirements of all medical devices and their components.
Additional guidance is also given in the ISO standards. These are standards that manufacturers must adhere or show equivalence to. There are specific standards for different medical devices, these can be found on the British Standards Institutes website here.
The MHRA continuously monitors device performance through incident reports and other information sources. Where a device is found not to be performing to the required standard or to have an issue that could cause harm to patients or users the MHRA work with the manufacturer to resolve the issue.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre