The Future of UKCA Marking for Medical Devices: Why UDI Is Taking Centre Stage

What Is Happening to UKCA Marking for Medical Devices?

The UK’s medical device regulatory framework continues to evolve, with the Medicines and Healthcare products Regulatory Agency (MHRA) confirming plans to remove the requirement for UKCA marking on medical devices once a new Unique Device Identification (UDI) system is fully implemented. This marks a significant shift away from reliance on a physical conformity symbol towards a digital, traceability-focused regulatory model.  

For manufacturers, importers, distributors and regulatory professionals, understanding this change is essential for future compliance planning.

The UKCA Marking Timeline

Following Brexit, the UK introduced the UK Conformity Assessed (UKCA) marking as the national product conformity mark for Great Britain. 

Key milestones in the development of the framework include: 

• March 2019: The UK government passed legislation to prepare the country’s product regulatory framework for life outside the European Union. 
• 1 January 2021: UKCA marking officially came into effect as part of the transition from EU regulatory requirements. 
• August 2023: The Department for Business and Trade announced the indefinite acceptance of CE-marked products across many regulated sectors, reducing immediate pressure on manufacturers to transition to UKCA marking. 
• July 2025: The government published its response to the MHRA consultation on international reliance, UKCA marking and in vitro diagnostic devices, confirming its intention to remove mandatory UKCA marking once UDI requirements are established.  

These developments demonstrate a gradual shift towards a more pragmatic and internationally aligned regulatory approach. 

What Is Changing for UKCA Marking?

The MHRA consulted on whether medical devices that have undergone the UK conformity assessment process should continue to require a UKCA mark on the device, packaging, instructions for use and associated labelling. 

Following feedback from manufacturers, trade associations, healthcare professionals and other stakeholders, the government confirmed that it intends to proceed with removing the requirement for UKCA marking.  

Importantly, this does not mean the removal of conformity assessment requirements. Manufacturers will still need to demonstrate compliance with UK medical device regulations before placing products on the Great Britain market. The proposal simply removes the obligation to display the UKCA symbol as evidence of that compliance. 

Why Is UKCA Marking Being Removed?

The primary driver behind the proposal is the planned introduction of a comprehensive Unique Device Identification (UDI) system. 

A UDI is a globally recognised sequence of alphanumeric characters that uniquely identifies a medical device. Typically presented as a barcode or machine-readable code, it enables regulators, healthcare providers and manufacturers to identify a specific device and trace it throughout its lifecycle. 

The MHRA believes that UDI can provide substantially greater value than a physical conformity mark by supporting: 

• Enhanced device traceability. 
• Faster identification of affected products during recalls. 
• Improved post-market surveillance. 
• Greater transparency throughout the supply chain. 
• Digital verification of compliance information. 
• Easier access to device information through searchable databases.  

Rather than relying on a symbol printed on packaging, future users will be able to access compliance information through digital systems linked to the device’s unique identifier.

What UKCA Marking Removal Means for Medical Device Regulation

One misconception is that removing UKCA marking means reducing regulatory oversight. However, the MHRA’s wider regulatory reform programme seeks to increase scrutiny before medical devices reach the market. 

According to the government’s consultation response, future pre-market legislation will introduce measures including: 

• Unique Device Identification (UDI). 
• Implant cards. 
• Updated device classification rules. 
• Enhanced requirements for consistency between product claims and intended purpose. 
• Greater regulatory oversight before devices are placed on the market.  

The overarching objectives of the programme are to strengthen patient safety, support innovation, align with international best practice, improve access to medical devices and ensure proportionate regulation.  

What Medical Device Manufacturers Need to Do

Although the UKCA symbol may eventually become optional, medical device manufacturers will still be required to meet their regulatory obligations. 

Future market access requirements are expected to include: 

• Registration of medical devices with the MHRA. 
• Compliance with UK post-market surveillance requirements. 
• Appointment of a UK Responsible Person where required. 
• Implementation and maintenance of UDI systems. 
• Continued compliance with applicable conformity assessment requirements.  

Manufacturers should therefore view UDI implementation as a strategic priority, rather than focusing solely on labelling changes. 

Will Existing UKCA Marks Need to Be Removed?

One of the concerns raised during consultation was the potential cost of relabelling products that already display a UKCA mark. 

The government’s approach addresses this concern directly. The intention is for the UKCA mark to become optional rather than prohibited. This means manufacturers that already apply the UKCA symbol would not be required to remove it from devices, packaging or instructions for use.  

This approach avoids unnecessary relabelling exercises, reduces costs and minimises disruption to supply chains. 

Benefits of Moving from UKCA Marking to UDI

The proposed change could deliver several practical advantages: 

Simplified Labelling. Manufacturers operating across multiple jurisdictions may be able to reduce market-specific packaging variations and simplify label management. 

Reduced Administrative Burden. Removing mandatory UKCA marking could decrease artwork updates, packaging revisions and associated regulatory administration. 

Better Traceability. UDI provides significantly richer information than a conformity mark alone, supporting more effective product tracking and recall management. 

Greater International Alignment. The move reflects broader global trends towards digital device identification and lifecycle traceability rather than reliance on physical symbols. 

Preparing for UDI in the UK

The MHRA’s July 2025 consultation response provides the strongest indication yet of the future direction of UK medical device regulation. The UKCA conformity assessment process is not disappearing, but the requirement to display the UKCA mark appears set to become a legacy feature of the regulatory system once UDI infrastructure is established.  

The guidance also highlights that registration records must be kept accurate and up to date. Manufacturers are expected to provide key information including manufacturer details, medical device classification, GMDN codes, device identifiers and, where applicable, Basic UDI-DI and UDI-DI information. This aligns with the wider regulatory direction described, where device identification, traceability and digital regulatory records will play an increasingly important role in demonstrating ongoing compliance. 

For medical device manufacturers, the focus should now shift towards preparing for UDI implementation, strengthening traceability processes and monitoring further MHRA guidance on timelines and database deployment. As the UK moves towards a more digital and data-driven regulatory framework, UDI is likely to become the primary mechanism by which device compliance, identification and traceability are demonstrated across the Great Britain market.