FOI release

Freedom of Information request about the MAGEC System (FOI-21-324)

Published 28 May 2021

Thank you for your email of 31 March 2021, in which you asked the MHRA to provide information on the following categories generated between 1 January 2016 and the present:

All correspondence (and attachments thereto) between Newcastle University employee/faculty/staff and the Medicines and Healthcare Products Regulatory Agency (“MHRA”) regarding the NuVasive MAGEC System.

All correspondence from any third party regarding the Field Safety Notice that was issued by NuVasive concerning the MAGEC System.

All clinical and/or other data relied on by MHRA to issue an April 1, 2020 Medical Device Alert relating to the MAGEC System.

All correspondence to or from any third party regarding the “robust investigation” performed by MHRA relating to the MAGEC System that was referenced in MHRA’s April 1, 2020 Medical Device Alert.

All correspondence between MHRA and NuVasive’s European Notified Body identifying safety-related concerns regarding the MAGEC System.

All correspondence between MHRA and any European Competent Authority identifying any safety-related concerns regarding the MAGEC System.

With respect to the above-referenced categories, you requested:

Confirmation of whether the information is held, regardless of whether it is ultimately produced

A copy of the information that is held

A detailed description of information not produced, and the reason such information is not produced

The information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA), detailed below.

If the manufacturer or the MHRA identifies a safety issue with this medical device, this will be communicated to the manufacturer’s customers and the health service through one or more of these communication routes.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

relates to the affairs of NuVasive Specialized Orthopedics, Inc., a business which continues to exist.

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: [email protected].

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/make-a-complaint/official-information-concerns-report/official-information-concern/ 

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU