On Wednesday 15 March 2023, the UK Chancellor set out plans to revolutionise the UK’s approval pathways for medicines and medical devices. The bold move will allow the MHRA to rely on “trusted” regulators including the EMA, the FDA and the PDMA (in Japan) rather than carrying out its own assessment to enable the MHRA to focus on more innovative products. In this article, we consider how these changes will impact UKCA marking for medical devices.
From 2024, the MHRA is set to allow rapid, “often near automatic” approval for medicines and medical devices, already approved by trusted regulators.
The MHRA already operates several reliance procedures established to smooth disruption arising from the UK’s exit from the European regulatory system. Before last week, these reliance procedures may have been viewed by some as a stop gap. However, the announcement makes it clear that reliance is the future.
Impact of foreign reliance on UKCA marking of medical devices
The UK currently allows CE marked medical devices to access the Great Britain (GB) market. Currently, the UK’s medical device legislation states that this will end on 30 June 2023 and that from this date all devices placed on the GB market must bear the UK’s new conformity marking, the UKCA mark.
However, last year the Government and the MHRA indicated, and industry widely expects, that this cut-off date will be significantly extended to dates in 2027 and 2029. These periods might be further extended in light of recent extensions implemented by the European Commission.
We read the budget announcement as being likely to lead to the scrapping of the cut-off date entirely. Accordingly, CE marked medical devices would have automatic access to the GB market.
It is harder to predict how this might work for US and Japanese “approvals” of medical devices.
For devices approved in the US, it is fairly safe to assume that “reliance” would include all devices which have received a premarket approval (PMA) from the FDA. However, it will be interesting to see how devices which have undergone a lighter-touch 510(k) process will be treated. It is possible that only a subset of devices that have undergone the 510(k) process will be allowed automatic access to the GB market.
Alongside the reliance routes, the Chancellor reiterated the creation of new approval pathways for innovative devices and IVDs (which had been flagged in the Government’s response to a consultation on the future regulatory framework for medical technology in the UK). These pathways are designed for novel devices and IVDs that have not yet been approved elsewhere. It is clear that the creation of these routes is aimed at pitching the UK as a global hub for innovation, where breakthrough technologies can rapidly receive regulatory approval. We expect that the UKCA mark’s future as regards medical devices lies with products approved through these routes.