Apps as medical devices

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References

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Our Ref: FOI 11/404

Dear Mr Smith,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 27th October 2011.

I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days
from our date of receipt.

If you need to contact us again about this request, please quote the
reference number above.

Yours Sincerely

Central Enquiry Point
Information Services
MHRA
151 Buckingham Palace Road
London
SW1W 9SZ

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James Smith

[1][FOI #91119 email]

       

       
22 November 2011        Our Ref: FOI 11/404    

Dear Mr Smith,

Thank you for your enquiry dated 26 October 2011 made under the Freedom of
Information Act 2000.

In your email, you requested MHRA registration details for any ‘apps’
registered with us as medical devices. I would like to inform you that
there is an obligation for UK based manufacturers and UK Authorised
Representatives of manufacturers outside Europe to register with us if
they manufacture the lowest risk class (Class I) devices, IVDs and custom
made devices. This registration is an administrative process and does not
involve a review of the devices. Manufacturers in other European member
states will be registered with their own Competent Authorities.

The registration process, using the RG2 form, only requires manufacturers
to register against a number of generic device types contained in Appendix
B to the form. A link to our website for these documents:

 [2]http://www.mhra.gov.uk/Howweregulate/Dev...
We do therefore not hold specific device information for each
manufacturer, nor whether any of these are in fact ‘apps’.

Our register of manufacturers is however available on our website, should
you wish to check specific manufacturers known to you:

[3]http://aic.mhra.gov.uk/era/pdr.nsf/name?...
Class IIa, IIb and III medical devices are CE marked by the manufacturer
in accordance with the regulations after successful assessments by a
Notified Body. These devices are not subject to registration with the
MHRA, and we are therefore unable to supply the information requested
regarding these classes of medical devices.

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 of receipt of the response to your
original letter and should be addressed to the MHRA Communications
Directorate, Floor 4T, 151 Buckingham Palace Road, London SW1W 9SZ.

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision. The Information Commissioner can be contacted at: Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9
5AF.

Yours Sincerely,
Tore Johansen
Regulatory Affairs Manager
Medicines and Healthcare products Regulatory Agency
ERA - Floor 5M
151 Buckingham Palace Road
Victoria
London SW1W 9SZ  - UK

Direct Line: +44 (0)20 3080 7235

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If you are not the intended recipient, please notify the sender
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you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

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Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. mailto:[FOI #91119 email]
2. http://www.mhra.gov.uk/Howweregulate/Dev...
3. http://aic.mhra.gov.uk/era/pdr.nsf/name?...

Dear Enquirer,

Thank you for your enquiry to the Central Enquiry Point at the MHRA. 

This automated response confirms that we have received your email and that
it will be dealt with as quickly as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. For further information about our service and how
we handle different types of request, please view the information
published at the ‘Central Enquiry Point’ section of our website at the
following link:

[1]http://www.mhra.gov.uk/Contactus/Central...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...

Dear Mr Smith,
       
Thank you for your recent enquiry to the MHRA.

Attached is the response to your request.
<<Review - 11-404.doc>>
Please contact us again if you need further assistance with any other
queries.
       
       
Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

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you have received.Incoming and outgoing email messages are routinely
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of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

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