What you should know about UKCA marking

If your medical device business plans to introduce its product to the $25bn UK market, you'll need to incorporate UKCA marking into your quality and regulatory planning.

UKCA marking demonstrates that your product has passed muster and is certified for sale in Great Britain - but getting it can be a complex and challenging process.

We took a deep dive into the UKCA marking roadmap - particularly for medical device companies - to give you everything you need to know to unlock the Great British market.

What is UKCA?

The United Kingdom Conformity Assessed (UKCA) mark is a product marking introduced by the United Kingdom to indicate conformity with domestic regulations.

After Brexit - the UK's departure from the European Union - the UKCA mark replaced the EU’s 'CE' (conformité européenne) marking system for products sold within Great Britain (England, Wales, and Scotland).

The UKCA mark certifies that products meet the necessary safety, health and environmental protection requirements as defined by UK law.

UKCA marking looks like this:

History and background of UKCA

UKCA marking was introduced as part of the United Kingdom's transition out of the European Union.

Before Brexit, manufacturers used CE marking to indicate that their products complied with EU regulations, which in turn allowed free movement of that product across the European Economic Area (EEA).

With the UK’s departure from the EU in 2020, a new independent regulatory system was required and the UKCA mark was introduced in 2021, becoming mandatory for products placed on the Great British market (excluding Northern Ireland).

Importance of UKCA

The UKCA mark is essential for businesses that want to continue selling products in the UK. Like the CE mark in Europe, it serves as a guarantee by the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) that the product has undergone formal safety assessments and complies with national regulations.

Without it, or (as we'll see below) a CE mark, manufacturers risk not being able to market their goods in England, Scotland and Wales.

UKCA marking vs CE marking

As businesses continue to adjust to post-Brexit changes 4 years after the divorce, understanding the differences between UKCA and CE marking is critical.

Both are forms of product conformity assessment, but are applied in different markets and governed by increasingly divergent regulatory frameworks.

Key differences

The key differences between UKCA marking and CE marking are as follows:

• Geographic scope: CE marking applies across the EU and certain other non-EU countries like Norway, Iceland and Liechtenstein. The UKCA mark is limited to Great Britain (England, Scotland, and Wales). Northern Ireland, as a special case within the UK, continues to use the CE mark in combination with its own UKNI marking in some cases.
  
  
• Standards: CE marking compliance for medical devices is based on EU MDR/IVDR compliance, and registration with the EU's Competent Authorities for Medical Devices (CAMD) and its EUDAMED database. UKCA marking adheres to the UK's Medical Device Regulations 2002, and registration with the MHRA.
  
  While these regulations are broadly identical for now (the UK MDR is primarily based on the older EU AIMDD, MDD and IVDD directives anyway), we can expect them to diverge over time as the UK revises its own independent regulatory stance. More on that below.
  
  
  
• Notified bodies: In the EU, conformity assessments are carried out by EU-recognized notified bodies. For UKCA marking, assessments are performed by UK-based approved bodies.
  
  
• Personnel: A UK Responsible Person (UKRP) is needed for non-UK manufacturers to complete the UKCA marking process. In the EU, you'll need an EU Authorised Representative (EAR).
  
  

Transition period and deadlines

Initially, businesses were allowed to continue using the CE mark in the UK only while they transitioned to UKCA compliance, with a hard-stop UKCA deadline of December 31, 2024.

That deadline, however, has been indefinitely moved back - creating a mixed period of both CE and UKCA mark acceptance for the foreseeable future.

At the same time, CE-marked medical devices can still be placed on the UK market from scratch using EU MDR certification until at least 2030. Even MDD certification is still accepted by the MHRA, depending on your device class, until 2028:

And a similar, slightly shifted transition timeframe is in place for in vitro devices:

Impact on businesses

The shift from CE to UKCA marking, while smoothed over with the ever-increasing transition timeframe, has significant implications for businesses.

Manufacturers that want to sell in both the EU and UK markets must now navigate two separate conformity assessment processes, which can increase administrative workload and costs.

For UK-based companies, exporting to the EU requires retaining CE marking while ensuring simultaneous UKCA compliance for domestic sales. This dual certification process can be complex.

Perhaps most importantly, you should stay vigilant as UK and EU regulations diverge over time.

Until replaced by MHRA-specific guidance, the UK MDR 2002 still relies on the use of the EU MEDDEV guidance documents and NBOG guidance where appropriate - but the Medicines & Medical Devices Act 2021 gave the UK the potential to overhaul the MDR and chart a new long-term post-Brexit course.

Understanding the UKCA mark

The UKCA mark is not just a label. UKCA marking signifies that your product has undergone a robust conformity assessment process and meets UK standards.

To achieve and retain UKCA marking, it's important for your business to understand its components and requirements.

Components of the UKCA mark

The UKCA mark, as the name suggests, is a physical marker that's applied to approved products. It must be placed visibly, legibly, and indelibly on the product and/or its packaging. It consists of the letters 'UKCA' in a standardized format, as we saw above.

Some products may also require an identification number linked to the UK approved body that conducted the conformity assessment. This proves that your product has been independently tested and certified.

Product categories covered

The UKCA mark isn't just for life science products.

UKCA marking covers a wide range of product categories, including but not limited to:

• Toys
• Electrical equipment
• Machinery
• Personal protective equipment (PPE)
• Construction products
• Medical devices
• Low voltage electrical equipment

Each category has specific standards that products must comply with, depending on their potential risk to consumers.

Conformity assessment process

The conformity assessment process varies depending on the product type. It typically involves:

1. Self-declaration: For lower-risk products, manufacturers can self-certify that their products meet UKCA requirements.
2. Third-party testing: Higher-risk products require testing and certification from an approved body.
3. Ongoing compliance: After initial certification, manufacturers must ensure ongoing compliance through product testing, auditing and maintaining technical documentation.

We'll go deeper into what the UKCA marking process looks like for your business below.

UKCA for medical devices

As you'd expect, medical devices are one of the most regulated product categories under the UKCA marking scheme.

Manufacturers of medical devices must undergo a rigorous conformity assessment to ensure their products meet the MHRA's high standards for safety and performance.

This assessment is typically conducted by a UK approved body for higher-risk devices. Additionally, manufacturers must submit a Declaration of Conformity and maintain a technical file that includes detailed product information, clinical evaluations and design records.

Are there exceptions to UKCA marking?

Certain products are exempt from UKCA marking. These include goods covered by specific international agreements, such as military equipment, or items that fall under other regulatory frameworks. In some cases, businesses may still need to demonstrate compliance with relevant safety regulations, but not through the UKCA mark.

You should not place a UKCA mark on your medical device if it is:

• A custom-made device
• Undergoing a clinical investigation (it must be marked as ‘exclusively for clinical investigation’)
• An IVD for performance evaluation
• A non-compliant device used in exceptional circumstances 
  
  

Steps for UKCA certification

For businesses looking to obtain UKCA certification, following the correct steps ensures a smooth and right-first-time process.

The UKCA marking pathway comprises 5 key steps you should follow:

Step 1: building a UKCA marking regulatory strategy

As with any regulatory hurdle, you should tackle UKCA marking as an integrated part of a broader, holistic strategy that minimizes work duplication and helps your business hit its core operational objectives.

Key questions to ask yourself at this stage include:

• Is your product a medical device or accessory?
• What legislation is applicable?
• What risk class does your medical device fall under?
• Is a QMS needed?
• Should you start in Europe or GB first?
• Can you reuse the documents?
• What product verification and validation is needed?
• What are the applicable standards?
• What's your clinical strategy?

Until you can answer all of these questions, you're not ready to start the detailed work that feeds into securing your UKCA mark.

Step 2: building a medical device QMS

Whether or not your device is low-risk Class I, it's still a good idea to build a functional QMS at this stage.

Maintaining MHRA compliance, keeping your UKCA marking intact, and continuously improving your business operation is much easier with a robust, well-integrated medical device quality management system.

Key ingredients of a medical device QMS include:

• Securing management responsibility and input
• Resource management
• Risk management
• Product realization
• Post-market surveillance system
• Communication with competent authorities
• Incident reporting & field safety corrective action
• CAPA management
• Monitoring & measurement

These operational ingredients should be documented, well managed and integrated into the lifecycle of your medical device, as follows:

You should also consider tackling ISO 13485 certification as part of this QMS building stage. Securing ISO 13485 certification will accelerate your GB go-to-market activity AND position you for EU (MDR/IVDR), US (FDA 21 CFR 820) and other international compliance too!

Plus, there's significant crossover between the UK MDR requirements you'll need to meet for UKCA marking and the international best practice requirements mapped out in ISO 13485:

Depending on your device's category and associated risks, testing processes should also be baked into your medical device QMS.

For high-risk devices, independent testing by a UK approved body is mandatory. The testing procedures assess factors like safety, durability and electromagnetic compatibility (EMC).

Low-risk products may undergo internal assessments where you as the manufacturer certify compliance without third-party involvement - so ensure you plan appropriately.

Step 3: building your technical documentation

You should now build and maintain a detailed file of technical documentation to support your UKCA marking process.

The key technical documentation you'll need is:

High-risk devices will also require clinical evaluation - another key step in the process.

Start by determining the state of the art, and perform a literature review for subject device and equivalent.

Then, in a similar way to a US 510(k), demonstrate equivalence to existing devices where you can using:

• • Clinical characteristics: intended use
  • Technical characteristics: design, specifications
  • Biological characteristics: materials, patient contact
    
    
•  

Fully document your clinical studies and investigations with GCP principles, and don’t neglect post-market surveillance/clinical follow-up plans too.

It's sometimes possible to justify why clinical data might not be needed here - so don't perform unnecessary tests for the sake of it.

Steps 4 and 5: approval, Declaration of Conformity, MHRA registration

Once everything is assembled, it's time to reach out to a UK approved body and to get your UKCA marking over the line.

The current approved bodies you can work with for your UKCA marking are as follows:

• BSI
• DEKRA
• SGS
• UL
• TUV Rheinland
• TUV SUD
• Intertek

The exact pathway you'll follow for your conformity assessment depends on the risk profile of your device.

We built a handy PDF guide to show you what each UKCA marking pathway looks like for each medical device class:

Download your UKCA marking pathway guide

After approval, you'll sign your UK MDR Declaration of Conformity. This must be completed before the UKCA mark is placed on your product.

And when you do get your mark, include the identification number for the approved body that completed your conformity assessment below the UKCA mark itself.

If you aren't a UK-based business, you’ll need to hire a UK Responsible Person for this step.

They should receive formal written authority to act on your behalf, and will be responsible for:

• Registering your device with the MHRA
• Reviewing and submitting your technical documentation
• Communicating with the MHRA, and with device users post-market

Congratulations - your device is now assessed, approved, registered and UKCA-marked!

Want some more guidance?

Watch our CE and UKCA marking roadmap webinar recording

Post-certification responsibilities

Once your product is UKCA-certified, you as the manufacturer have ongoing responsibilities to ensure continued compliance. These include:

• Regular product testing and quality assurance checks
• Keeping your technical file updated with any product modifications
• Responding to any safety incidents or reports of non-compliance

Additionally, you must ensure that your UKCA mark remains legible and visible on your product throughout its lifecycle - and isn't obscured by design updates, poor labeling, packaging oversights and the like.

What happens if a product fails to meet UKCA requirements?

If your product fails to meet UKCA requirements after marketing, you may face severe penalties, including product recalls, fines, and even being banned from operation in the GB market.

To avoid this, thoroughly review all documentation at set intervals, conduct frequent and repeatable testing, and communicate proactively with your approved body if any concerns arise.

If non-compliance is identified after your product has been released, immediate corrective action must be taken, which could include reworking the product, retesting, or withdrawing it from the market.

Benefits of complying with UKCA marking

Why bother with UKCA marking?

It's a long, complex process.

But if the British market aligns with your business plan, there are a few key benefits.

Market access

The key advantage of securing long-term UKCA marking is continued market access within Great Britain, one of the largest economies in Europe.

By ensuring your products are UKCA-marked, you can confidently sell your products in the 6th-largest medical device market on Earth.

Quality and safety

Forcing your business to go through the MHRA conformity assessment process optimizes your product safety, cutting the risk of recalls, complaints and legal disputes.

Businesses that prioritize UKCA marking and long-term MHRA compliance can publicly show off their commitment to rigorous safety and quality standards and demonstrate that their products have been designed, tested and manufactured to meet strict safety requirements. 

A consistent focus on the quality and performance of your product can only be a good thing: more sales, fewer defects, and a longer product lifecycle underpinned by effective design controls and risk management.

Using an eQMS to get and keep your UKCA mark

One of the most efficient, fast and effective ways to obtain and maintain your UKCA mark is by implementing an electronic quality management system powered by dedicated UKCA marking software.

A well-implemented eQMS can streamline your UKCA certification process by providing a structured and collaborative approach to managing your device quality and compliance.

From building and collaborating on all your UKCA documents from a single source of truth, to applying a digital framework for managing device risks and design controls, UKCA marking software makes it easy to assemble and present the information that your UK approved body needs to see to grant your UKCA mark.

Qualio customers report 90+% reductions in their regulatory approval times, with months shaved from their go-to-market plans.

Check out our UKCA marking software to crack the Great British market at record speed!