MHRA Early Access: a new pathway for innovative medical devices in the UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced the upcoming launch of a new Early Access service to support faster adoption of innovative medical devices, particularly in areas where there is an unmet clinical need.
The official announcement was published on 31 July 2025 and is available on the UK Government website. Read the full MHRA announcement here.
This initiative is part of the UK’s ambition to become a global leader in health technology innovation and supports the Life Sciences Sector Vision and the 10-Year NHS Plan. The goal is to help promising technologies reach patients faster, even before full regulatory approval, provided that there is robust supporting evidence of patient benefit.
A real opportunity for manufacturers
The MHRA Early Access medical devices service will be open to all innovators, with a particular focus on diagnostic devices that meet the most urgent needs of the NHS. Startups and SMEs are explicitly encouraged to participate.
Rather than replacing the formal conformity assessment, Early Access will allow for a temporary, controlled use of a device ahead of approval. This enables early feedback from clinicians and patients, which can also support future market entry and evidence generation.
Based on real experience and stakeholder input
The Early Access service builds on learnings from the Innovative Devices Access Pathway (IDAP) pilot and the Unmet Clinical Need Authorisation (UCNA) tool. The MHRA intends to shape this new pathway in close collaboration with key stakeholders, including NHS organisations, clinicians, and industry representatives.
The focus will be on ensuring safety, transparency and patient benefit, while allowing companies to bring innovative solutions to the UK market more efficiently.
Aligned with wider regulatory reforms
The MHRA Early Access medical devices initiative forms part of broader regulatory reform in the UK. It complements other actions such as:
- Stronger post-market surveillance
- Increased international regulatory cooperation
- Wider use of reliance on trusted global regulatory partners
These reforms aim to strengthen the UK’s regulatory environment while keeping it innovation-friendly and aligned with patient needs.
For medical device manufacturers, this new pathway represents a valuable strategic opportunity. Early Access offers not only faster entry but also early real-world insights that can support long-term success.
If you’re working on an innovative product and want to assess whether the MHRA Early Access medical devices pathway is right for you, get in touch.
We’ll help you define the best regulatory strategy to support patient access and compliance in the UK market.
