The UK reclaims a leading role in clinical research: What this means for medical device and IVD manufacturers
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
In recent years, the clinical research landscape in the United Kingdom has undergone a remarkable transformation.
According to a recent analysis by the MHRA (Medicines and Healthcare products Regulatory Agency), clinical trial applications increased by 20% between 2018 and 2022. This growth has been accompanied by shorter review times and stronger collaboration between key regulatory bodies, such as the Health Research Authority and the devolved administrations.
More than just a positive signal, these figures point to a clear shift: the UK is embracing a more efficient, innovation-friendly regulatory model.
For companies operating in the medical device and in vitro diagnostic (IVD) sectors, this opens the door to real strategic advantages.
With its first in-depth report of this kind, MHRA isn’t just sharing data, it’s sending a message. The UK regulatory system is not only ready to support new clinical investigations, but is also committed to doing so through more agile tools and closer institutional coordination.
One of the most important developments is the improvement in review timelines. A streamlined process, clearer communication with authorities, and a regulatory structure that minimizes uncertainty are turning the UK into a competitive environment for companies ready to bring new technologies to market.
Beyond speed, it’s the overall quality of the process that makes the difference: greater transparency, institutional alignment, and a proactive attitude toward early-stage innovation all point to a system that’s evolving.
Beyond clinical research, manufacturers planning to market their devices in the UK must navigate a distinct regulatory framework.
For companies based outside the UK, one of the key requirements is the appointment of a UK Responsible Person (UKRP), an authorized representative established within the country who ensures compliance with UK-specific regulatory obligations and serves as the liaison with MHRA.
Rather than a barrier, this regulatory shift can be seen as an opportunity to build a stronger, more strategic market access plan.
For those planning clinical trials or expanding their international presence, the UK now offers a more welcoming environment, one where innovation is supported by clearer rules and more predictable timelines.
If you’re looking to adapt your strategy and take advantage of this evolving landscape, we can support you every step of the way: from clinical planning to product registration and UKCA documentation.
Discover how we can support you as a UK Responsible Person for the UK market.
