Freedom of Information request on when RISUG will be approved in the UK (FOI 21-598)
Published 13 August 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-1-june-2021/freedom-of-information-request-on-when-risug-will-be-approved-in-the-uk-foi-21-598
3rd June 2021 FOI 21/598
Dear
Thank you for your information request, dated 29 May 2021, where you asked when RISUG was going to be approved in the UK.
Unfortunately MHRA is not involved in this process and the manufacturer needs the intervention of a third party body (A UK Approved Body or an EU Notified Body). Can I suggest you have a look at the following guidance which provides information on the regulatory process which the manufacturer needs to follow : https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements
You may wish to contact the manufacturer who should be able to update you with any application they have in place with a UK Approved Body or an EU Notified Body.
If you have any queries, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU