MHRA proposes sensible new plan for boosting medical devices in UK
Was Brexit good for the UK? It depends on your perspective. For UK life sciences businesses, the “B” word still provides strong opinions. Some people have accepted the decision even if they think it was a mistake. Others think that Brexit provided a good opportunity for the sector, but the UK could have done more to benefit from the opportunities or “Brexit freedoms”. The debate rumbles on.
One aspect in the aftermath of Brexit was the decision to introduce the UKCA mark instead of the trusted CE mark for equipment including medical devices. A lot in the medtech community in the UK saw this as a mistake. Yes, it gave the UK its own standard, which could involve trust. But is that what the business community or patients wanted or needed?
Well, the MHRA - the UK's life sciences regulator - has now taken a new stance. It has listened to the market and there now seems to be an acceptance that working with a common CE trust mark as well as relying on approvals from other trusted regulators around the world (such as the US, Canada and Australia) is the way to go, and there seems the real prospect of ending the requirement to have the UKCA mark. Was this experiment folly, or is this just sensible pragmatism now? Is this what “global Britain” means -having a trusted regulator that is not out on its own, but working with other international regulators? I believe so. Either way, it's good that the MHRA has been listening and looking to make life easier for medtech suppliers to get products on the market in the UK. This will ultimately benefit business and patients.
Hot on the heels of the recent publication of the UK’s Life Sciences Sector Plan and Industrial Strategy, as well as the 10 Year NHS Plan for England, this is intended to reduce barriers getting transformative technologies to patients faster.
The PING Conference in 2026 will look at Britain's place in the life sciences world, 10 years on from the Brexit vote. I think we're still working out what that means. What do you think?
I'd be interested to hear any thoughts you have on these developments? Do contact me on pgershlick@vwv.co.uk