UKCA Mark vs CE Mark: Key Differences and Implications for Your Business

A ‘CE Mark’ (Conformité Européenne) is a feature you’ll see across many types of devices and equipment. From machinery to electronics, the CE mark shows that the item is compliant with the various health, safety and environmental legislation of the European Union. In the UK, we also have the UKCA (UK Conformity Assessed) mark, which demonstrates compliance with UK legislation. Both are recognised internationally.

Changes to regulations following Brexit meant that there would be changes needed for the UK in which the UKCA mark would need to be displayed for products available in the UK markets. The Government has since provided updates to these changes, meaning the CE mark will continue to be recognised.

There is a lot to unpack here around your responsibilities as a business and what any changes mean for your operations. Understanding the differences between these marks and their implications for your business is crucial for maintaining compliance and market access.

In this article, we’ll take a closer look at the UKCA Mark vs the CE Mark and explain what it means for your business.

What is the CE Mark?

The CE mark is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It ensures that products, including medical devices, meet the requirements outlined in the EU Medical Devices Regulation. It is widely recognised and covers a vast range of products, from electronics to medical devices.

What is the UKCA Mark?

The UKCA mark is the new product marking required for goods being placed on the market in Great Britain (England, Scotland, and Wales). It was introduced following the UK’s departure from the EU to replace the CE mark within the UK market. The UKCA mark requires conformity assessments conducted by UK Approved Bodies.

Transitioning from CE to UKCA: The key points

The main points you need to know about the changes to the UK’s regulations for medical devices are:

· New Regulations Implementation: The UK government plans to introduce new regulations for medical devices, prioritising patient safety, access to necessary devices, and maintaining market attractiveness for medical technology innovators. These regulations will ensure that devices meet relevant requirements, whether through self-declaration for lower-risk devices or formal assessments by designated bodies for higher-risk products. The phased implementation, detailed in the 2024 Roadmap, begins with enhanced post-market surveillance in 2024 and core regulatory elements by 2025.

· Extended CE Mark Acceptance: Legislation amending the UK Medical Device Regulations extends the acceptance of CE-marked medical devices on the Great Britain market. This allows for continued supply and smooth transition to the new regulatory framework, with different deadlines based on device types and compliance status.

· Timeline for CE Marked Devices: CE-marked general medical devices compliant with EU MDD/AIMDD can be placed on the GB market until the sooner of either certificate expiry or 30 June 2028. IVDs compliant with EU IVDD have until 30 June 2030, and devices compliant with EU MDR/IVDR until 30 June 2030, facilitating prolonged market presence.

· Class I Device Provisions: Class I medical devices self-declared against EU MDR or compliant with MDD requirements before 26 May 2021 can be placed on the GB market until 30 June 2030 and 2028, respectively. Sterile or measuring function Class I devices with valid MDD certificates are accepted until 30 June 2028. Renewed EU MDR and IVDR certificates are valid until 30 June 2030, pending further review and updates.

Key Differences Between the UKCA Mark and CE Mark

While the purpose of the UKCA mark and CE mark are the same, they adhere to different relevant legislation, leading to differences in the areas they are relevant to and the regulatory standards they must adhere to. Some of the key differences include:

Geographical scope

CE Mark: Required for products sold in the EEA and recognised in several other countries.

Qualifying Northern Ireland goods can be marketed in Great Britain with only a CE mark, exempting them from the UKCA marking requirement.

UKCA Mark: Required for products sold in Great Britain. Note that Northern Ireland follows a different regime (the UKNI mark alongside the CE mark).

Regulatory standards

CE Mark: Products must meet EU regulatory standards.

UKCA Mark: Products must comply with UK regulatory standards, which initially mirrored EU standards but may change over time.

Validity and recognition

CE Mark: Recognised and valid within the EEA and in countries accepting CE marking.

UKCA Mark: Only recognised within Great Britain; not valid in the EEA.

Implications for Your Business

The changes to regulations could have a significant impact on your business, so it’s important to know how the changes affect you:

UK product safety

Ensuring UK product safety involves meeting the regulatory requirements of the market where the product will be sold. For businesses operating in both the UK and EU, this means adhering to both UK and EU standards, which could potentially increase compliance costs and administrative burden.

UK regulatory standards

UK regulatory standards initially aligned with EU standards, but businesses need to stay updated on any changes. Any differences in standards could affect product design, manufacturing processes, and supply chains.

CE Mark Medical Devices

For medical devices, the CE mark ensures conformity with EU medical device regulations. Post-Brexit, medical devices sold in Great Britain require the UKCA mark. Companies must navigate the relevant regulatory pathways for both marks, involving different notified bodies and compliance procedures.

Active implantable medical devices fall under stringent regulatory frameworks and require conformity assessments by UK Approved Bodies.

While this may seem like a complex issue to navigate, using a company like JPen Medical to carry out your medical equipment safety testing can help ensure that the devices you are using comply with the relevant standards, giving you peace of mind that your equipment is safe to use.

How to obtain the UKCA Mark for medical devices

Below are the steps you need to take to obtain the UKCA mark for medical devices:

Determine applicability

Verify that your medical device falls under the UK regulations that require the UKCA mark.

Appoint a responsible person

Non-UK manufacturers must appoint a UK responsible person to handle compliance duties.

Meet UK regulatory requirements

Ensure your medical device complies with relevant UK regulations, including safety, performance, and labelling standards.

Conformity assessment

Conduct a conformity assessment via UK conformity assessment bodies to ensure compliance with UK regulations.

Affix the UKCA Mark

Once compliance is confirmed, affix the UKCA mark to your product. Ensure all documentation and declarations of conformity are in order.

Register your device

Keep your medical devices compliant with JPen Medical

While navigating the transition from the CE mark to the UKCA mark seems like a complex process, the overall aim is to ensure the safety of equipment manufactured and used in the UK. Understanding the key differences and implications for your business can help you maintain compliance, ensuring you’re doing the best for your business and your patients.

The transition period offers some leeway, but businesses must prepare for the new regulatory landscape to ensure continued market access and compliance.

At JPen Medical, we meet all best practice standards in relation to our testing equipment. All of your medical devices and equipment will be fully tested to CQC, MHRA, and IEC 62353 in-service test standards, ensuring they are safe to use within your premises. This can help give you assurance, and ensure that testing is left in the hands of experts.

For further information about our services, contact JPen Medical today and let us help you with this transition. By proactively adapting to these changes, your business can mitigate risks, reduce compliance costs, and maintain the highest levels of medical device safety for your patients and staff.