FOI release

Freedom of Information request (FOI 22/886)

Published 17 January 2024

FOI 22/886

24th August 2022

Dear

Thank you for your request under the Freedom of Information Act (FOIA).

By way of introduction, the Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care. We regulate medical devices in the UK with the aim of ensuring that they meet the standards set out in the UK Medical Devices Regulations 2002. As part of our regulatory function, we perform market surveillance of medical devices on the UK market and can take decisions over the marketing and supply of devices in the UK.

One of our main responsibilities is the investigation of “signals” arising from “adverse incident” reports involving medical devices and other data sources. An adverse incident is an event that caused, or could have caused, harm / injury to a patient or other person, or perhaps a wrong or delayed diagnosis and/or treatment of a patient. A signal is an indication from any source which suggests a concern regarding one or multiple medical devices and justifies subsequent action.

In 2020 we began an in-depth review of the PRECICE system, as a result of a safety signal. The MHRA found the long-term biological safety profile of the PRECICE System was unknown, and these devices had not been validated for use in children and adolescents by the manufacturer. Statements were issued by NuVasive and the MHRA in January 2021 to recall and suspend these devices from the UK market.

The findings from the MHRA review were passed onto the manufacturer’s Notified Body. Notified Bodies are independent organisations who undertake pre-market assessments to ensure that manufacturers, and their medical devices, meet the correct requirements.

In March 2021 NuVasive (NSO), the manufacturer of the device, informed the MHRA that their CE certification for the PRECICE system had been suspended by their Notified Body.

To date, the CE certification has not been reinstated by NSO’s Notified Body for the Precice Bone Transport, Precice Stryde, Precice Plate. Therefore, these sub-systems cannot be placed on the UK or European market.

The CE certification has been reinstated for the other PRECICE sub-systems: the Precice IMLL, Precice Short, Precice Unyte, Precice Opty-Line, and Precice Freedom. These devices will remain suspended from the UK market whilst we complete our investigation. The MHRA needs to ensure our initial safety concerns with these devices have been addressed by the manufacturer.

The MHRA’s review of the PRECICE system is still ongoing. I can assure you we are taking this matter very seriously. We cannot make any decisions about allowing the device to be used in the UK again until we have been able to complete a full review of all the information.

Last month we met with our independent Expert Advisory Group to discuss the safety evidence provided by the manufacturer. This group is formed of external clinicians and engineers who have been advising us throughout the duration of this investigation. They have advised us of additional actions to complete to ensure risks are reduced as far as possible before we consider whether the suspension can be lifted. Unfortunately, we do not have a timeline for when this will be, but we are working on this as a priority.

Please be aware, the manufacturer has updated the intended use of the PRECICE system to adults only. NSO issued a Field Safety Notice in October 2021, which you may have already seen. If not, please find a copy attached for your reference.

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 Agency who was not involved with the original decision.

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

Please remember to quote the reference number above in any future communications.

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 at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre