FOI release

Freedom of Information request for a copy of the 'UK MDR 2002' (FOI 21/441)

Published 28 June 2021

25th May 2021 FOI 21/441 Dear

Thank you for your information request. In your email dated 5 May 2021 you have asked for a copy of the ‘UK MDR 2002’. This follows your previous email dated 30 April 2021 seeking a copy of the UK MDR 2002 which you note MHRA has defined as ‘the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).’

The Medical Devices Regulations 2002 were amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. These regulations should all be read together. Unfortunately, there is not a freely available copy of the The Medical Devices Regulations 2002 which incorporate all amendments made to the regulations to date - this needs to be made by the legislation.gov.uk editorial team which you may wish to contact about this. There are legal firms that provide consolidated versions of legislation which you can purchase whom you may wish to contact also.

The information you have requested is exempt from release under certain exemptions in the Freedom of Information Act 2000.

Firstly, it is exempt from release under section 21 – information accessible by other means: the information you have requested is already in the public domain. It can be found at the links above (albeit not in a consolidated version of the regulations that incorporates all amendments to date). You can also look to purchase a consolidated version from a legal firm. The Freedom of Information (FOI) Act’s section 21 exemption states that there is no right of access to information via FOI if it is reasonably available to the applicant by another route.

While MHRA does hold a copy of the UK Medical Devices Regulations which incorporates some of the amendments since it was originally enacted, releasing it to you would be a breach of the terms on which we accessed it. Unfortunately that information is also exempt from release to you on the following grounds:

1. Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed. The copy of the regulations mentioned above was provided to us with the expectation it would be held in confidence.

2. Section 43 – Commercial interests: information where disclosure would be likely to prejudice the commercial interests of any person that holds the information. We anticipate that releasing the above mentioned copy of regulations to you would, or would be likely to, prejudice the commercial interests of the firm which provided it as it could impact its ability to generate income from providing its consolidated version to others. It would also prejudice the MHRA’s commercial interests as it would breach the terms on which the copy was provided to us and may also deter commercial entities from engaging with us to provide consolidated regulations in future.

Section 43 is a qualified exemption and we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider there is public benefit in having access to copies of medical devices regulations to aide understanding of the regulations governing medical devices placed on the UK market. However, given the regulations are already accessible (as noted above), we consider overall the public interest will be better served by not releasing the above mentioned copy of the regulations we hold given this would prejudice a firm’s commercial interests and could deter future production of consolidated versions of regulations or engagement with the MHRA to provide these which assists our regulatory work.

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 MHRA who was not involved with the original decision.

If you have a query about the information provided, 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