top of page
  • Writer's pictureStephen Randall

UK Proposes Recognition of FDA-Cleared and CE Marked Medical Devices.

Welcome news for US companies looking to expand across the pond.

Doctor examining a UK patient

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has just dropped a major announcement that could be significant for American healthcare companies. The agency is proposing a new framework for the international recognition of medical devices, making it easier for FDA-cleared and CE marked devices to enter the UK market. This news is a beacon of opportunity for US-based companies looking to expand their footprint across the pond, and it’s packed with implications worth unpacking.

Post-Brexit, many healthcare companies faced the daunting prospect of navigating a separate regulatory pathway for the UK. The additional time and investment required to go through yet another regulatory approval process, on top of the CE marking for Europe, was a significant burden for companies looking at their international budgets, as well as a competitive disadvantage for the UK. The MHRA’s new framework mitigates the need for a complete re-evaluation under UK-specific regulations, significantly reducing the regulatory burden and associated costs.

For USA healthcare companies, this could be a golden opportunity. Historically, gaining approval to market medical devices in smaller markets still involved navigating a labyrinth of regulations, re-submitting clinical data, and enduring long waiting periods. Now companies can avoid the redundancy of undergoing multiple rounds of testing and certification, reducing overall expenses. Simplifying the regulatory pathway translates to significant cost savings.


 Ultimately, this means that patients in the UK will have faster access to advanced medical technologies.


Being able to finally tap into the UK healthcare market will help reestablish US brands across the pond. Ultimately, this means that patients in the UK will have faster access to advanced medical technologies. For companies driven by a mission to improve health outcomes, this is a win-win scenario.

The MHRA’s move is a forward-thinking, pragmatic approach to regulation. It’s an acknowledgment that medical device safety and innovation transcends borders and that trust in established regulatory processes can facilitate better, faster access to life-saving technologies.

If you’re a medical device company with FDA-cleared products, now is the time to gear up for the UK market. As an ex-pat running a US health-tech business, I'm personally looking forward to bringing innovative healthcare solutions to Britannia.

References and further reading:

MHRA announces a proposed framework for international recognition of medical devices



bottom of page