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Update on MHRA restructuring and BIVDA engagement

By June 10, 2022No Comments

As many members will know, MHRA has been undergoing a re-structuring to bring all elements of healthcare regulation together. But meanwhile they have lost critical IVD expertise with recent moves by Graeme Tonbridge, Mike Messenger and Camilla Fleetcroft.

This week however Dr Penny Wilson, who will be familiar to many of you, took up position as a Deputy Director  and I hope to have a meeting with her in the near future. Penny was previously with Innovate UK but has been on secondment to the UK HSA during the pandemic.

MHRA are officially launching their new structure and strategy on 27th June and BIVDA has been asked, as one of their key stakeholders, to  provide a ‘talking head’ style video as part of the communications package around this launch.

The Government response to the consultation on the new UK regulations for medical devices and IVDs will shortly be published along with a  new timetable for the focus group engagement meetings and other information including transition plans – likely to also extend beyond the original date of 1 July 2023 for coming into force but that remains to be seen!

As with the EU, having sufficient Approved Bodies in place will be critical and there are currently 3 designated for medical devices with a further 5 applications in process, 2 of which have had the designation audits so nearing completion of the process. The understanding however is that these are all from EU Notified Bodies and will probably only be able to support their existing client bases. The Approved Bodies will also have different scopes so not all will cover IVDs or if they do then potentially all IVD product risk classes.

Ben Kemp