UKCA Marking for Medical Devices: Addressing Commonly Asked Questions

Post-Brexit, there has been some confusion about the future use of UKCA (UK Conformity Assessed) markings and when they must appear on products and packaging. This article offers insights on what medical device developers need to know about the latest timetables and technicalities of the transition from the EU CE marking to the UKCA.

What Is the UKCA Marking?

The UKCA marking is a certification mark that indicates a product, including medical devices, conforms to UK regulatory requirements and standards. Following Brexit, this marking was intended to replace the CE marking (which signaled conformity with EU regulations) as an indication a product could legally be sold in the UK. However, this goal has been subject to several delays and backtracks since the UK voted to leave the European Union. In addition, it’s worth noting Northern Ireland will continue to use the CE marking permanently as part of the Northern Ireland Protocol.

Will the UKCA Marking Be Required for Every Product Sold in the UK?

Most recently, the UK government performed a U-turn on its decision to replace the EU CE marking for all goods sold in England, Scotland, and Wales. It’s been reported that there are now 18 areas where the implementation of the UKCA will be delayed indefinitely.¹ These include machinery, low-voltage electrical equipment, ATEX equipment for potentially explosive atmospheres, and lifts. Some manufacturers are relieved they will be saved the need to duplicate efforts in seeking two sets of almost identical approvals.

Will Medical Devices Require the New UKCA Marking?

Yes. Medical device developers are not included in the list of excluded product types. Instead, the UK government is intent on implementing the UKCA marking as part of conformity requirements for medical devices sold in the UK. This reflects the different regulatory environment in medtech that will be maintained by the MHRA (Medicines and Healthcare Products Regulatory Agency) post-Brexit.

What Regulations Apply to Developers Selling Medical Devices in the UK?

Developers who want to sell their medical devices in the UK are currently required to adhere to regulations set out in the Medical Devices Regulations 2002 (as amended), which implemented into domestic legislation three EU Directives:

• Medical Devices Directive (93/42/EEC) (as amended by 2007/47/EC)
• Active Implantable Medical Devices Directive (90/385/EEC)
• In Vitro Diagnostic Medical Devices Directive (98/79/EC)

How Will the EU and UK Regulations Diverge?

The UK regulations are administered and overseen by the MHRA (the UK’s regulatory body). Although currently based on the EU legislation, over time, these will develop into more UK-specific regulations. Politicians hope the ability to determine the UK’s own regulation will give a new kind of freedom and flexibility for UK developers to compete internationally. As the Chancellor said in the 2023 budget statement:

“From 2024, [the MHRA] will move to a different [regulatory] model, which will allow rapid, often near-automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe, and Japan. At the same time, it will set up a swift new approval process for the most cutting-edge medicines and devices to ensure that the UK becomes a global centre for their development.”²

However, the transition to the new regulatory regime is taking more time than expected.

What’s the Latest Timetable for Implementing UKCA Markings for Medical Devices?

The UK government had announced the new UK legislation and the UKCA Marking deadline of July 2023 would be postponed for medical device developers. It now appears the deadline for both will be July 2025. However, the MHRA will continue to recognize EU CE marking for an extended transition period from 2028-2030 depending on the type of device.

What Is the Process for Securing Your UKCA Marking?

The MHRA has designated UK-approved bodies³ to oversee and ensure the compliance of medical devices and products within the UK market. These bodies are equivalent to the EU Notified Bodies that ensure conformity with EU law. The UK-approved bodies are responsible for conducting assessments, certifications, and regular audits to ensure medical products meet the necessary safety and performance standards.

Ten Steps to Managing the Transition to the UKCA Marking

1. Register Your Product—Before placing a medical device on the UK market, manufacturers (or their authorized representative) must register with the MHRA.
2. Appoint an Authorized Representative—If the manufacturer is not based in the UK, they must appoint a UK-based representative (aka, the “UK Responsible Person”).
3. Understand Which CA Route Applies to You—Depending on the classification of its medical device, manufacturers will need to choose an appropriate conformity assessment route. Some devices can be self-certified, while others will need a more rigorous assessment based on their classification and risk profile. Information on UK classification system can be found on the UK government’s website.
4. Engage a UK-Approved Body—For certain classes of medical devices, manufacturers will need to select a UK-approved body with which to work. This body will evaluate the device to ensure it meets the necessary regulatory requirements.
5. Prepare Your Technical Documentation—Manufacturers will need to prepare the technical documentation that provides evidence of conformity with the relevant legislation. This documentation will be reviewed by the UK-approved body.
6. Undertake Conformity Assessment—The UK-approved body will conduct a conformity assessment, which may include inspecting the manufacturing site, reviewing technical documentation, and testing the device.
7. Declaration of Conformity—Once the device has been assessed and deemed to meet all requirements, the manufacturer will need to draw up a UK Declaration of Conformity. This is a formal statement indicating the device complies with the relevant regulations.
8. Affix the UKCA Mark—After the Declaration of Conformity is complete, the manufacturer can affix the UKCA mark to the device. The marking must be visible, legible, and indelible.
9. Post-Market Surveillance—Even after obtaining the UKCA mark, be aware manufacturers will have ongoing responsibilities to be answerable to the MHRA, including monitoring the performance of the device in the market and reporting any adverse events. There are new post-market surveillance requirements promised by the MHRA that developers should take note of.
10. Renewal and Updates—Depending on the device and the chosen conformity assessment route, manufacturers may need to undergo periodic reviews or renewals with their UK-approved body.

Conclusion

There is no doubt, following Brexit, there will be additional work for medical device developers as they prepare to sell their devices in the UK and EU. After all, there are now two separate regulatory regimes to comply with. At least both regimes (and now the FDA) strongly align with ISO 13485:2016. If you have gained this standard—and are using the right eQMS software—it should be relatively straightforward to assemble the required documentation and manage audits by the relevant certifying bodies.

Finally, as various UKCA deadlines come and go—or are shuffled around—smart device developers are following the news, working closely with consultants to verify they have the best advice, and ensure the digital tools they are using are as agile and flexible as possible. 

References

1. tinyurl.com/mpo240781
2. tinyurl.com/mpo240782
3. tinyurl.com/mpo240783

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and Fortune 500 companies, Byrne has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices, and product development, Byrne is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigor.