Brexit and Medical Device Regulations: What’s Changed for UKCA Marking?

12 Mar

Brexit has reshaped the regulatory framework for medical devices in the United Kingdom, significantly impacting manufacturers seeking market access. One of the most critical changes is the introduction of the UK Conformity Assessed (UKCA) marking, which replaces the European Union's CE marking for most products sold in Great Britain. This shift has brought about new challenges, regulatory requirements, and compliance obligations for medical device companies.

Understanding these changes is essential for manufacturers to ensure uninterrupted market access and continued regulatory compliance. This article provides a detailed breakdown of the impact of Brexit on medical device regulations, the role of UKCA marking, and the necessary steps for manufacturers to place their products on the UK market.

The Transition from CE to UKCA Marking: What Medical Device Manufacturers Need to Know

Before Brexit, medical devices sold in the United Kingdom were required to carry the CE marking, signifying compliance with European Union (EU) regulations. The CE marking indicated that a product met the strict safety, health, and environmental requirements set by the EU and allowed manufacturers to sell their products freely across all EU member states, including the UK, without needing separate national approvals. This harmonised system facilitated trade and ensured consistency in product quality and safety across Europe.

However, following the UK’s departure from the EU, the government aimed to establish an independent regulatory framework for medical devices and other goods. This led to the introduction of the UK Conformity Assessed (UKCA) marking, which was designed as a replacement for the CE mark for most goods placed on the market in England, Scotland, and Wales. The UKCA marking serves as an indicator that a product meets UK-specific regulations and has undergone the necessary conformity assessment procedures.

While this change was initially intended to provide the UK with greater regulatory control, it has resulted in new compliance challenges for manufacturers - particularly those who sell products in both the UK and EU markets. Instead of meeting one unified set of standards under the CE marking, manufacturers now face the prospect of complying with two separate regulatory systems.

Key Differences Between CE and UKCA Marking

Although UKCA marking was introduced to replace CE marking, the UK has retained the older EU Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostic Directive (IVDD) (98/79/EC) as its current regulatory framework. This means UKCA marking requirements are still based on the pre-MDR/IVDR system, though future regulatory updates may introduce new requirements. However, there are key differences that manufacturers need to consider:

Regulatory Authority – Under CE marking, medical devices are regulated by national Competent Authorities in EU member states, with conformity assessments conducted by EU Notified Bodies where applicable. The European Medicines Agency (EMA) does not regulate medical devices but is responsible for medicinal products and certain combination products. With UKCA marking, the Medicines and Healthcare products Regulatory Agency (MHRA) is solely responsible for overseeing medical device regulation in Great Britain.
Approval Bodies – Devices that previously required assessment from an EU Notified Body must now undergo certification by a UK Approved Body for UKCA marking. EU Notified Bodies are no longer recognised for UKCA conformity assessments, meaning manufacturers that previously relied on these bodies must find an alternative Approved Body in the UK.
Scope of Application – UKCA marking only applies to products sold in Great Britain (England, Scotland, and Wales). It is not recognised in Northern Ireland, which continues to follow EU regulations under the Northern Ireland Protocol. This means that medical devices placed on the Northern Ireland market must still carry the CE mark. If a UK Approved Body conducts the conformity assessment for a device intended for Northern Ireland, the device must bear both the UKNI marking and the CE marking.
Transitional Provisions – While UKCA marking is intended to become mandatory, the UK government has extended the acceptance of CE-marked devices multiple times to prevent disruption. Initially, UKCA compliance was expected to be enforced from 1st January 2022, but this deadline was extended to 1 July 2023 and later revised again. On 1st August 2023, the UK government confirmed that CE marking would remain accepted indefinitely for most medical devices, although this policy remains subject to future regulatory developments. While UKCA marking is not yet a strict requirement, manufacturers should monitor MHRA guidance for potential updates on its enforcement.
Future Regulatory Developments – Although UKCA marking is not currently mandatory, manufacturers must remain prepared for future regulatory changes. The MHRA is developing a new UK-specific regulatory framework for medical devices, which may introduce stricter clinical evidence requirements, enhanced post-market surveillance obligations, and further divergence from EU rules. Manufacturers should regularly review MHRA updates to ensure ongoing compliance. Keeping up to date with MHRA announcements and planned reforms will be essential for long-term compliance.

Current Market Realities and Implications for Manufacturers

For the time being, the indefinite acceptance of CE-marked devices in the UK provides regulatory flexibility for manufacturers, reducing the immediate need for dual certification. However, this does not mean that UKCA marking should be ignored. UK-based manufacturers who only sell in Great Britain will still need to ensure they comply with UKCA regulations once they become mandatory.

For manufacturers selling in both the UK and EU, the requirement for separate approvals under the CE and UKCA systems increases administrative workload, regulatory costs, and complexity in supply chain management. Companies must be prepared for additional documentation, regulatory fees, and potential delays associated with obtaining certifications from both EU Notified Bodies and UK Approved Bodies.

Additionally, while CE marking remains valid in the UK, some UK regulatory processes - such as medical device registrations with the MHRA - must still be completed separately from EU procedures. This means that even if a manufacturer does not yet require UKCA marking, they must still register their devices with the MHRA before they can be placed on the UK market.

UKCA Marking for Legacy and New Medical Devices

Another key consideration is whether a product is a legacy device or a newly developed device. Legacy devices that were CE-marked before Brexit can continue to be sold in the UK under existing transitional provisions. However, manufacturers introducing new medical devices after the final implementation of UKCA rules will need to undergo a fresh conformity assessment under the UKCA system.

For medical devices classified as high-risk (Class III or IIb implantable devices), this means they will likely require third-party assessment from a UK Approved Body to receive UKCA certification. Lower-risk devices may follow self-certification routes, but the exact requirements depend on the regulatory framework that will be in place when UKCA marking becomes fully mandatory.

Preparing for the Future of UKCA Marking

While UKCA marking is not yet compulsory, manufacturers should take proactive steps to prepare for a future where CE marking may no longer be accepted in Great Britain. Key actions include:

Monitoring regulatory updates from the MHRA to stay ahead of any deadlines or changes to the transition period.
Engaging with a UK Approved Body (if required) early to avoid delays when UKCA marking does become mandatory.
Ensuring UK device registrations with the MHRA are up to date, regardless of CE marking status.
Reviewing product labelling and documentation to ensure they align with both UKCA and CE requirements where necessary.
Developing a dual compliance strategy for manufacturers selling in both the UK and EU to minimise administrative burden and streamline regulatory approvals.

By understanding the key differences between CE and UKCA marking and preparing for future regulatory shifts, manufacturers can ensure smooth market access and avoid potential disruptions when UKCA compliance becomes fully enforced.

Steps for Manufacturers to Achieve UK Market Access

For medical device manufacturers looking to place their products on the UK market, compliance with UK regulations is essential. While the indefinite acceptance of CE-marked devices provides some flexibility, manufacturers should take proactive measures to ensure they meet UK-specific requirements. The process involves multiple steps, including regulatory classification, engagement with UK Approved Bodies, product registration with the Medicines and Healthcare products Regulatory Agency (MHRA), and ongoing post-market surveillance.

A structured approach to compliance not only facilitates smooth market entry but also ensures patient safety and regulatory integrity. Below is a detailed breakdown of the key steps required to achieve UK market access:

1. Determine Device Classification

Medical devices are categorised into different risk classes based on their intended use, design, and interaction with the human body. The classification determines the conformity assessment pathway and regulatory requirements a manufacturer must follow.

The UK uses a classification system similar to the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746).
Higher-risk devices (such as Class III medical devices and certain Class IIb implantable devices) require more stringent regulatory scrutiny, including third-party certification by a UK Approved Body.
Lower-risk devices (such as Class I non-sterile, non-measuring devices) may be eligible for self-certification, reducing regulatory burdens.

To ensure compliance, manufacturers must correctly classify their device under the UK’s medical device regulations and determine whether third-party approval is required. Misclassification can lead to delays, non-compliance penalties, or even product recalls.

2. Engage a UK Approved Body (If Applicable)

For medical devices requiring third-party conformity assessment, manufacturers must work with a UK Approved Body. This is particularly important for:

High-risk devices (Class III, Class IIb implantables).
Devices that previously relied on EU Notified Bodies, which are no longer recognised under the UK system.
Certain in vitro diagnostic (IVD) devices, which require rigorous assessment.

UK Approved Bodies assess whether a medical device meets UK regulatory requirements before granting UKCA certification. Unlike CE marking, UKCA certification cannot be obtained from an EU Notified Body. This means manufacturers who were previously working with an EU Notified Body must now find a UK equivalent.

Due to limited capacity among UK Approved Bodies, early engagement is essential to avoid approval delays. Manufacturers should:

Identify and partner with a reputable UK Approved Body as soon as possible.
Prepare technical documentation, risk assessments, and clinical evaluation reports in accordance with UK regulatory requirements.
Ensuring their quality management system (QMS) aligns with ISO 13485 for manufacturing controls and ISO 14971 for risk management to streamline certification. Additionally, manufacturers must comply with the MHRA's post-market surveillance (PMS) and vigilance reporting requirements, including mandatory adverse event reporting and periodic safety updates.

For some manufacturers, particularly those selling in both the UK and EU, maintaining compliance under both UKCA and CE marking systems may require working with multiple regulatory bodies.

3. Appoint a UK Responsible Person (UKRP)

For manufacturers based outside the UK, appointing a UK Responsible Person (UKRP) is mandatory. The UKRP acts as the legal representative within the UK, ensuring the manufacturer’s regulatory obligations are met.

The UKRP’s responsibilities include:

Registering the device with the MHRA on behalf of the manufacturer.
Holding technical documentation and making it available for inspection by regulators.
Ensuring post-market surveillance compliance, including adverse event reporting.
Acting as a liaison between the manufacturer and the MHRA.

Manufacturers should choose a UKRP that:

Has expertise in UK medical device regulations.
Can provide ongoing regulatory support to maintain compliance.
Has a physical presence in the UK, as required by law.

Manufacturers cannot act as their own UKRP unless they are based in the UK. Many companies choose to work with regulatory consultancies that offer UKRP services to streamline compliance.

4. Register the Device with the MHRA

All medical devices, regardless of their risk classification, must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they can be placed on the UK market. Manufacturers based outside the UK must appoint a UK Responsible Person (UKRP) to carry out this registration on their behalf.

UK-based manufacturers must register their devices directly.
Non-UK manufacturers must register through their UKRP.

The registration process requires:

Device classification details and intended use.
Technical documentation demonstrating compliance.
UKRP details (if applicable).
Post-market surveillance and vigilance procedures.

The MHRA operates an online registration system, but the process can take time, especially for high-risk devices. Delays in MHRA registration can prevent products from being placed on the UK market, so manufacturers should prioritise registration early to avoid supply chain disruptions.

5. Update Labelling and Documentation

To comply with UK regulations, medical devices must be labelled correctly. Key labelling requirements include:

The UKCA marking (once mandatory) must be displayed prominently on the device, packaging, or instructions for use (IFU).
If a UKRP is required, their name and address must be included on the product label.
Dual compliance: Devices sold in both the UK and EU may carry both UKCA and CE markings, as long as they meet both regulatory standards.

Additionally, manufacturers must maintain up-to-date technical documentation, including:

Clinical evidence demonstrating device safety and effectiveness.
Risk management files in line with ISO 14971.
Post-market surveillance plans.

Failing to update labelling and documentation can result in regulatory penalties or market access restrictions.

6. Implement Post-Market Surveillance

Regulatory compliance does not end at product approval - manufacturers must establish robust post-market surveillance (PMS) systems to monitor device safety and performance.

Key PMS obligations include:

Proactively collecting and analysing real-world data on device performance.
Reporting adverse incidents to the MHRA under the vigilance system.
Implementing corrective and preventive actions (CAPA) if safety concerns arise.
Periodic safety updates, especially for high-risk devices.

A well-maintained PMS system ensures continued compliance and prevents costly recalls or regulatory interventions.

Challenges and Considerations for Manufacturers

Regulatory Uncertainty

The UK’s medical device regulations are still evolving, and the timeline for mandatory UKCA marking remains uncertain. Manufacturers must stay updated on regulatory changes to avoid compliance gaps.

Dual Compliance Burden

Companies selling in both the UK and EU must meet separate regulatory requirements for CE and UKCA marking. This adds costs, administrative burdens, and time-consuming certification processes.

Supply Chain Disruptions

Brexit-related supply chain challenges have caused delays in raw material procurement, increased shipping costs, and logistical inefficiencies. Manufacturers should develop contingency plans to mitigate these risks.

Achieving UK market access requires careful planning, regulatory expertise, and proactive compliance measures. By classifying devices correctly, working with UK Approved Bodies, appointing a UKRP, registering with the MHRA, updating documentation, and maintaining post-market surveillance, manufacturers can navigate the complexities of UK regulations and ensure continued market presence.

Staying ahead of regulatory changes and adopting a dual-compliance strategy will be crucial for manufacturers seeking long-term success in both the UK and EU medical device markets.

Conclusion

Brexit has significantly altered the regulatory environment for medical devices in the UK, with the introduction of the UKCA marking and new compliance obligations. While CE-marked devices are still accepted, manufacturers must prepare for future regulatory shifts and ensure they meet UK-specific requirements.

To achieve UK market access, manufacturers must understand the role of UK Approved Bodies, appoint a UK Responsible Person if necessary, register devices with the MHRA, and implement robust post-market surveillance measures. Staying up to date with regulatory changes and proactively adapting to evolving requirements will be crucial for continued success in the UK medical device market.

By taking a strategic approach to compliance, manufacturers can navigate the post-Brexit regulatory landscape and continue to provide safe, effective medical devices to patients and healthcare providers in the United Kingdom.

Steven Clarke