What I Learned About UK Market Access for Medical Devices
Key Principles and New Changes in 2025
Hello Dear,
Welcome back!
I hope you’re finding these updates insightful. Today, I want to talk about a topic that’s particularly important for anyone working in regulatory or clinical evaluation:
The principles of market access in the UK and the current regulatory landscape in 2025.
What Are the Principles of Market Access?
Market access in the UK is built around four main pillars:
Patient:
How does the device improve patient outcomes?
Does it address unmet needs or enhance quality of life?
Provider:
How does the device integrate into healthcare delivery?
Is it designed to be practical and effective in clinical settings?
Payer:
Is the device cost-effective for the NHS or other payers?
Can you demonstrate its value in terms of both outcomes and cost savings?
Product:
Is the device innovative, safe, and effective?
Does it meet the necessary regulatory standards, such as UKCA or CE marking?
These principles aren’t isolated; they overlap and need to work together for successful market access.
UKCA vs. CE Marking: The Current Status
As of January 2025, the UKCA (UK Conformity Assessed) marking is not yet mandatory for medical devices entering the UK market. The UK government has extended the acceptance of CE-marked devices in Great Britain (England, Wales, and Scotland) beyond previous deadlines. Here’s a quick summary:
General medical devices compliant with the EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) can remain on the market until the sooner of certificate expiry or 30 June 2028.
In vitro diagnostic devices (IVDs) compliant with the EU In Vitro Diagnostic Medical Devices Directive (IVDD) are allowed until the sooner of certificate expiry or 30 June 2030.
Devices compliant with EU MDR and IVDR can remain on the market until 30 June 2030.
While the UKCA marking is available and manufacturers can opt to use it, the CE marking remains valid for most devices in Great Britain during these transition periods.
Important note: Northern Ireland follows different rules, requiring CE marking for medical devices.
Why This Matters
For manufacturers, this means more time to prepare for UKCA marking, but it’s not a reason to delay. The transition is inevitable, and starting early will save you time and resources in the long run.
The Opportunity in 2025
The UK’s evolving regulatory landscape provides an opportunity for proactive companies. By leveraging the extended CE marking acceptance period, you can focus on strengthening your clinical evidence, aligning with NHS priorities, and preparing for a seamless transition to UKCA marking.
This is particularly relevant for devices already approved in the EU, US, or Japan, as the UK government aims to simplify and accelerate the approval process.
My Takeaway
While the CE marking remains valid in Great Britain for now, don’t wait until the last minute to prepare for UKCA marking.
Start by ensuring your clinical evidence is robust, your intended purpose aligns with regulatory requirements, and your market access strategy addresses patient, provider, and payer needs.
P.S.: In my following newsletter, I’ll dive into how to optimize clinical strategy to meet requirements from regulators and payers/HTA. Don’t miss it!
✌️ Peace,
Hatem