November 3, 2026
Short answer: The MHRA has drafted new pre-market regulations for medical devices and IVDs in Great Britain. They are expected to be adopted around the end of 2026, with most changes applying from June 2027. The headline changes are mandatory UDI, implant cards, a smoother route for software updates, a new international reliance route for devices approved in the US, Canada and Australia, and a risk-based classification system for IVDs.
The UK has been working towards a new device framework since leaving the EU. Post-market surveillance came first, with new rules in force since June 2025. Long-term recognition of CE marked devices was confirmed in October 2026. The pre-market regulations are the next big piece, and they will reshape how UKCA marking works.
Great Britain still largely runs on the UK Medical Devices Regulations 2002, which are based on the old EU Directives. The EU has since moved to the MDR and IVDR. The MHRA's aim is to modernise the GB framework, improve patient safety and traceability, and make it easier for innovative products to reach patients.
The draft regulations were published in May 2026 and notified to the World Trade Organization, with an impact survey for industry. Adoption is expected around December 2026.
Every device placed on the GB market will need a Unique Device Identifier. A UDI is a code on the label and packaging, often a barcode, that identifies the specific device. It makes recalls and incident tracing far more precise.
If you already apply UDI for the EU or the US, you are well placed. If not, treat this as a labelling, artwork and data project, and start early.
Patients with implantable devices will receive an implant card with key information about the device. Manufacturers will need to supply the card and the information that goes on it.
Software as a medical device changes far more often than hardware. Under the new rules, manufacturers will be able to agree a predetermined change control plan (PCCP) in advance. This sets out how the software is expected to change and how those changes will be validated. Updates that stay within the plan should not need a fresh conformity assessment each time.
The rules also bring clearer cybersecurity expectations for software and connected devices. This is particularly relevant for AI-enabled devices, which may learn and update over their lifetime. See our UK software as a medical device services for more.
Devices already approved by regulators in the US, Canada or Australia will have a route to the GB market that leans on that approval, rather than repeating a full assessment. Eligible devices will still need English labelling, a UDI and a UK Responsible Person. This route is expected later than the main changes, around mid-2028.
CE marked devices are handled separately through long-term recognition, which we explain in how to sell a CE marked medical device in Great Britain.
This is the biggest change in the package for many companies. Most IVDs in Great Britain are currently self-declared under a list-based system. The new rules introduce four risk classes, A to D, similar to the EU IVDR:
Many tests will move up a class, which means an Approved Body will need to be involved for the first time. Approved Body capacity in the UK is limited, so early planning matters. Our UK IVD services page has more on how we support IVD manufacturers.
Technical documentation will need to be kept for the lifetime of the device plus 10 years, or 15 years for implantable devices. The draft rules also tighten expectations on equivalence and claims, and widen the use of electronic instructions for use.
Classification rules for general medical devices and active implantables are also being revised to bring them closer to current practice. Some devices may change class, so check your portfolio against the final rules once they are published.
Transition periods are expected, so this will not be a cliff edge. The MHRA's impact survey will help shape how changes are phased in. Keep an eye on MHRA guidance for the final dates.
The MHRA's draft pre-market regulations are expected to be adopted around the end of 2026, with most provisions applying from June 2027. The international reliance route is expected around mid-2028.
Yes. UKCA marking remains the UK's own route to the GB market. The requirements behind it are being updated by the new regulations.
CE marked devices will continue to be recognised in Great Britain long term. However, requirements such as MHRA registration, UDI and post-market surveillance still apply to devices on the GB market.
It is a plan, agreed in advance, that sets out how a software medical device is expected to change and how those changes will be verified and validated. Changes within the plan can be made without a new conformity assessment each time.
IVDs will move to a risk-based system with four classes, A to D, similar to the EU IVDR. Higher-risk classes will need assessment by a UK Approved Body.
We help manufacturers plan for regulatory change before it becomes urgent. That includes portfolio classification reviews, UDI planning, technical documentation updates and choosing the right route to the GB market. Explore our UK medical device services, or contact our team to talk through what the 2027 changes mean for your products.
