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Medicines & Healthcare products

Regulatory Agency 151 Buckingham Palace Road
United Kingdom
LifeVac Europe Ltd

30 August 2017

LifeVac anti-choking device

I am writing to you further to my letter of 19 May, when I requested additional information which was
necessary for the MHRA to give full consideration to the regulatory issues relating to placing your
product on the UK market. I am grateful to you for providing that information in a timely manner; we
have now had the opportunity to consider the additional information and have reached a conclusion
on how we propose to proceed.

In my letter, I referred to MEDDEV 2.7/1, a guide produced by the European Commission, that
promotes a- common approach to clinical evaluation and specifically highlighted the section which
referred to devices for unmet medical needs. One of our main concerns has been a lack of sufficient
data demonstrating effective use of this device and we understand that due to the nature of the
. device, clinical trials would be extremely difficult. The proposals set out below are intended to allow
you to gather clinical data in a controlled environment, with trained healthcare professionals, which
will allow you to generate more robust results over time. These can then be incorporated into your
clinical evaluation which, once sufficient evidence has been generated, may allow agreement of
extending the availability of the device.

We are therefore requesting that you take all reasonable steps to ensure that your device should only
be used in the following situations:

• By registered healthcare professionals or individuals with advanced life support training,

only if currently recognised basic life support protocols have failed; or
• In situations where emergency services are unable to respond, for example on aeroplanes
or ships, only if currently recognised basic life support protocols have failed; or
• On individuals in moulded wheelchairs, only if currently recognised basic life support
protocols have failed.

Taking this into account, we would request that you alter your instructions for use, as well as any
relevant supplementary marketing information to emphasise that your device should only be used
under these conditions.

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Medicines & Healthcare products
Regulatory Agency

We would also request that you cease to market your device for use on children, in schools and in
other public places such as restaurants and shopping centres.

I should advise that, based on the information provided to us thus far, we do not consider that your
current plans for post-market surveillance, in particular the lack of structured post-market clinical
follow-up, would be able to generate sufficient clinical evidence to expand the use of your device. The
approach that we have proposed above should allow you to refine your plans for post-market
surveillance; healthcare professionals will understand the experimental nature of your device and how
it fits with basic life support and provide more structured post-market surveillance data.

I would like to thank you for your patience and co-operation in this matter. The MHRA believes the
approach outlined in this letter, which at this stage is based on voluntary cooperation as opposed to
formal regulatory action, strikes a balance that will allow you to continue your business but also gather
information for clinical evaluation in a more controlled clinical environment that minimises the potential
patient safety issues.

I would be grateful for a response to this letter by 20 September setting out your acceptance of the
conditions in this letter and an outline of how you intend to comply with them.

Yours sincerely,

Graeme Tunbridge
Group Manager - Devices Regulatory Affairs
Tel: 02030806901

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