Freedom of Information request on an update regarding the MHRA's investigation regarding the Precice bone transplant nail (FOI 21-515)
Published 13 August 2021
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11th June 2021 FOI 21/515
Dear
Thank you for your email of 15 May 2021, where you asked the MHRA to provide an update on our investigation regarding the Precice bone transplant nail, manufactured by NuVasive Specialized Orthopedics (NSO).
On 25 March 2021, NSO informed the MHRA that their CE certification for the Precice System had been suspended by their EU Notified Body. NSO have published a statement on their website with further information. This can be found using the following link.
At present the UK continues to recognise CE marked medical devices and will do so until 30 June 2023. Therefore, under normal circumstances, providing a medical device has been properly CE marked, this medical device can continue to be used in the UK.
In this instance, the suspension of the Precice System’s CE certificate prevents the device being placed on the UK market. If CE certification is reinstated by the Notified Body and the MHRA has been able to review all the relevant information on the safety and performance of the device, we will reconsider our position on allowing the supply of the device to the UK market.
I hope you find the above information helpful.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU