On December 31, 2020, the Brexit transition phase ended, along with the validity of EU regulations in the UK. Since leaving the EU, the United Kingdom (UK) has been struggling with corresponding hurdles. There is a shortage of workers in some sectors, sales to the EU have decreased, and there have been significant costs associated with the adjustment of administration and customs duties. The MedTech regulations in the UK also fall under these adjustments. At the time of its withdrawal from the EU, the UK was supposed to fall under the jurisdiction of the EU MDR. As this plan did not work out, the UK MDR was implemented instead.
The UK MDR includes the requirements of its EU MDR predecessors: Active Implantable Medical Devices Directive (AIMDD), In Vitro Diagnostic Medical Devices Directive (IVDD), and Medical Devices Directive (MDD). Therefore, in January 2024, the Medicines & Healthcare Products Regulatory Agency (MHRA) published a roadmap to improve patient safety. It pays particular attention to post-market surveillance, which is to be strengthened in the future. What exactly does the roadmap envisage? Which transitional regulations will continue to apply to medical devices? And what alternative is there for the EU CE marking?
CE marking in Great Britain: UKCA
Since the end of the transition period, the MedTech industry in the United Kingdom has had a CE marking equivalent known as UKCA (UK Conformity Assessed). Its issuance depends on compliance with the UK MDR. However, the CE mark remains accepted, although only until certain transition deadlines.
- Medical devices compliant with the MDD and AIMDD may continue to be placed on the market until 30 June 2028, or until their declaration of conformity expires, whichever comes first.
- In vitro diagnostic devices compliant with the IVDD may continue to be placed on the market until 30 June 2030, or until their declaration of conformity expires, whichever comes first.
- Medical devices, including custom-made devices, compliant with the MDR, as well as IVDs compliant with the IVDR, may continue to be placed on the market until 30 June 2030, or until their declaration of conformity expires, whichever comes first.
UDI Requirements in the United Kingdom
The regulatory basis for UDI requirements in Great Britain remains the UK Medical Devices Regulations 2002 (UK MDR 2002). These regulations were originally introduced to implement the former EU directives and, following Brexit, continue to apply as standalone UK medical device legislation.
However, with the publication of the draft Medical Devices (Amendment) Regulations 2026 on 8 May 2026, the MHRA plans a comprehensive modernization of the existing regulatory framework. A central component of this reform is the mandatory introduction of a Unique Device Identification (UDI) system for medical devices and IVDs.
It is important to note the legal status of these proposals. At the time of this research, the draft legislation was still progressing through the legislative process. The consultation period ran until 19 June 2026, and adoption is expected by the end of 2026. Therefore, the proposed rules are not yet in force but are considered a highly concrete regulatory development.
Timeline Overview
The introduction of UDI in the UK forms part of a broader reform of medical device regulation.
Key Milestones
- 2002: UK Medical Devices Regulations 2002 enter into force.
- 16 June 2025: Enhanced Post-Market Surveillance (PMS) requirements come into effect.
- 8 May 2026: Publication of the draft Medical Devices (Amendment) Regulations 2026.
- 19 June 2026: End of the consultation period.
- Expected by end of 2026: Adoption of the new regulation.
- 1 June 2027: Planned enforcement date for mandatory UDI requirements.
- From 2028 onward: Planned launch of the International Reliance Pathway.
- 30 June 2028 / 30 June 2030: Current transition periods for CE-marked products on the UK market.
For manufacturers, this means that although the obligation is not yet in force, there is still sufficient time for preparation, provided that the necessary processes are established early.
What Does the Planned UDI Requirement Include?
This section is particularly relevant for medical device manufacturers, as it outlines the specific requirements of the proposed reform.
1. Introduction of a Three-Part UDI Structure
The MHRA closely follows the existing EU MDR concept. The planned UDI structure consists of:
- Basic UDI-DI for identifying a product family.
- UDI-DI as the specific product identifier.
- UDI-PI for production-related information such as batch numbers, serial numbers, or expiration dates.
This approach aligns the UK with international standards already familiar to manufacturers operating in the EU, United States, and Australia.
2. Labelling on Products and Packaging
The UDI will be required on:
- The device itself, where technically feasible.
- The label.
- All levels of packaging.
Both machine-readable and human-readable formats are envisaged, for example through barcode solutions based on established standards such as GS1 and ISO/IEC 15459.
3. Submission of Selected UDI Data to the MHRA
According to the current draft, only the following data elements must be submitted to the MHRA database during registration:
- Basic UDI-DI
- UDI-DI
The UDI-PI will not be submitted to the database. Batch numbers, serial numbers, and expiry dates will remain part of the physical product labeling and will not be centrally stored due to their continuously changing nature.
Registered UDI data is expected to be searchable through a publicly accessible system, similar to EUDAMED, the Global Unique Device Identification Database (GUDID) in the United States, and Australia’s AusUDID.
4. No Phased Introduction by Risk Class
While many countries introduce UDI requirements gradually based on device risk classes, the UK is currently pursuing a different approach.
The draft regulation proposes that mandatory UDI requirements will apply to all medical devices and IVDs from June 2027 onward, regardless of their risk classification.
Product Registration Is Already Mandatory
Even without UDI requirements, manufacturers must already register their products with the MHRA. The existing Device Online Registration System (DORS) serves as the central registration platform for medical devices of all risk classes, as well as IVDs.
DORS will continue to be the platform used for the registration of medical devices and IVDs. Manufacturers located outside the UK must appoint a UK Responsible Person, comparable to the European Authorized Representative, who acts as the point of contact with the MHRA.
Registration is already mandatory today, and a wide range of information must be provided, including:
- Manufacturer information
- Product and device information
- GMDN codes
- Evidence of conformity
- Existing Basic UDI-DI and UDI-DI information
The fact that UDI-related fields are already available demonstrates that the MHRA is proactively preparing its systems for future UDI requirements.
What Should Manufacturers Do Now?
Although the UDI requirement has not yet been formally adopted, MedTech companies can already take important preparatory measures.
- Ensure High-Quality EUDAMED Data
- Organizations that already maintain structured UDI data for EUDAMED possess the most important foundation for future UK requirements.
- Do Not Confuse MHRA Registration with UDI
- Registration in the DORS system is already mandatory and remains independent of the planned UDI regulation.
- Appoint a UK Responsible Person
- Companies located outside the United Kingdom should appoint a suitable UK Responsible Person if they have not already done so.
- Monitor the Legislative Process
- As certain details remain subject to change, manufacturers should continuously monitor updates from both the MHRA and the UK legislator.
Post-Market Surveillance in the UK
Through its new Post-Market Surveillance (PMS) Regulations, the MHRA has significantly strengthened requirements for monitoring medical devices after they have been placed on the market.
These rules have applied since 16 June 2025 to medical devices, IVDs, and active implantable medical devices in Great Britain, regardless of whether they bear the CE mark or the UKCA mark.
Manufacturers are now required to operate a more comprehensive PMS system that ensures the ongoing collection and evaluation of safety and performance data throughout the entire product lifecycle.
Key Changes Include:
- A clear definition of the PMS period, beginning when a device model is first placed on the market or first put into service and continuing until the end of the lifetime of the last unit placed on the market.
- An explicit MHRA recommendation to continue collecting relevant safety data beyond the validated device lifetime where continued use can reasonably be expected.
- A more precise definition of reportable serious incidents, including incidents that have led, or could have led, to death, serious deterioration in health, or a serious public health threat.
- Clarification that measures or treatments undertaken to prevent serious deterioration in health must also be considered when evaluating incidents.
Although non-serious incidents do not need to be reported individually to the MHRA, they remain part of the PMS process and must be documented, analyzed through trend reporting, and included in PMS reports and Periodic Safety Update Reports (PSURs).
The MHRA’s objective is to identify potential risks earlier and improve patient safety throughout the entire lifecycle of a device.
Companies Prepared for EUDAMED Are Also Well Positioned for the UK
The planned UK UDI requirement clearly demonstrates that international regulatory frameworks are increasingly converging around common identification and data standards.
For manufacturers already managing their UDI data for EUDAMED, the starting point is highly favorable. The MHRA’s planned requirements are largely based on the MDR framework. As a result, the additional organizational and technical effort required for the UK market is expected to remain manageable.
Companies already managing their UDI data through the mytracekey UDI Manager are particularly well prepared for future UK requirements. Leveraging existing data enables new regulatory obligations to be implemented more quickly and with significantly less effort.
The UK’s intended approach is to ensure system readiness and minimize supply disruptions to pave the way for a safer and more innovative healthcare landscape.
[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: August 2026)
This information is only one possible interpretation of the regulations. Also, they are in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: May 2024)