FOI release

Freedom of Information request about exemptions under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002 (FOI-21-019)

Published 7 May 2021

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11th March 2021 FOI 21-019

Dear

Thank you for your email of 11 February 2021 in which you asked for:

  1. a list of all the instances between 2012 and 2019 where an exemption was granted under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002, or if that is considered disproportionate, the approximate number;

  2. a list of all the instances between 2012 and 2019 where an exemption was granted under regulation 174 of the Medical Devices Regulations 2002, or if that is considered disproportionate, the approximate number.

Please find instances of an exemption being granted by year for question 1 below.

2012	2013	2014	2015	2016	2017	2018	2019 Regulation 12(5) and Regulation 26(3) combined	7		2	1	2	91	76	75 Regulation 39(2)	1	1	1	1	0	0	0	0

Question 2: Regulation 174, under Part IX of the Medical Devices Regulations 2002. This was introduced by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. However, Part IX did not apply until 26 May 2022. Furthermore, the whole Part has been removed by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. Therefore, there have not been any instances where regulation 174 has been used.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

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 online: https://ico.org.uk/

If you have a query about the information provided, please reply to this email.

Yours sincerely Enquiries Co-ordinator Devices Division Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU

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