Updated: 24th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is the Difference Between CE Marking and UKCA Marking?
If you manufacture medical devices for the European or Great Britain markets, understanding the difference between CE Marking and UKCA (UK Conformity Assessed) Marking is essential. Although both markings demonstrate that a medical device meets applicable regulatory requirements, they are governed by different legislation, apply to different markets and involve different regulatory authorities.
CE Marking demonstrates conformity with the European Union Medical Device Regulation (EU) 2017/745 (EU MDR) or the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). It allows manufacturers to place compliant medical devices on the market throughout the European Economic Area (EEA) and, subject to local requirements, other countries that recognise CE marking.
UKCA Marking was introduced following the United Kingdom’s departure from the European Union and demonstrates conformity with the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended. UKCA marking is intended for medical devices placed on the market in Great Britain (England, Scotland and Wales), while Northern Ireland continues to follow separate arrangements under the Windsor Framework.
For many manufacturers, the distinction is not simply choosing between CE Marking or UKCA Marking. Businesses selling devices in both the EU and Great Britain often need to comply with both regulatory systems. This may include maintaining separate Declarations of Conformity, appointing both an EU Authorised Representative and a UK Responsible Person, registering devices with the relevant authorities and ensuring labelling reflects the intended markets.
Although the UK Government currently recognises many CE-marked medical devices in Great Britain under transitional arrangements extending to 30 June 2030, manufacturers should not assume this position will continue indefinitely. Organisations planning long-term access to both markets should understand the differences between the two regulatory frameworks and develop a compliance strategy that supports future market access.
This guide compares CE Marking and UKCA Marking for medical devices, explains where each marking applies, outlines the current transition arrangements and helps manufacturers determine which regulatory pathway is appropriate for their products.
Important Update (2026): At the time of writing, the UK Government and the MHRA are consulting on proposals to indefinitely recognise CE-marked medical devices that comply with the EU MDR and IVDR in Great Britain. Until a final decision is made, the current transitional arrangements remain in force, with CE-marked devices generally accepted until 30 June 2030. Manufacturers should continue to monitor regulatory developments and plan their market access strategy accordingly.
New to the EU MDR?
This article compares CE Marking and UKCA marking for medical devices. If you're looking for a complete introduction to Regulation (EU) 2017/745, including device classification, Article 10 obligations, GSPRs, clinical evaluation, Technical Documentation, UDI, EUDAMED and CE marking requirements, explore our EU MDR for Beginners Guide.
What Is CE Marking?
CE Marking is a conformity marking that demonstrates a medical device complies with the applicable European Union legislation before it is placed on the market. For medical devices, this means compliance with either the European Medical Device Regulation (EU) 2017/745 (EU MDR) or the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
By affixing the CE mark, a manufacturer declares that the device meets the relevant legal requirements relating to safety, performance and quality. Depending on the classification of the device, this may involve assessment by an independent Notified Body before the device can be legally marketed.
CE Marking provides access to the markets of the European Economic Area (EEA), which includes all EU Member States as well as Iceland, Liechtenstein and Norway. Many countries outside Europe also recognise or accept CE-marked medical devices as part of their own regulatory frameworks, making it an important route for manufacturers seeking international market access.
Obtaining CE Marking requires manufacturers to establish and maintain comprehensive technical documentation demonstrating that their device complies with the applicable legislation. This typically includes:
- Device classification under the EU MDR or IVDR
- Compliance with the General Safety and Performance Requirements (GSPRs)
- Risk management in accordance with ISO 14971
- Clinical Evaluation (or Performance Evaluation for IVDs)
- Post-Market Surveillance planning
- Technical Documentation and Declaration of Conformity
- Assessment by a Notified Body where required
For manufacturers established outside the European Union, an EU Authorised Representative must also be appointed before placing most devices on the European market.
Although CE Marking demonstrates compliance with European legislation, it does not automatically satisfy the regulatory requirements for placing medical devices on the Great Britain market. The following section explains how UKCA marking differs and when manufacturers may need to comply with the UK regulatory framework in addition to the EU MDR.
Need Help Achieving CE Marking?
This article explains how CE Marking compares with UKCA marking. If you're looking for a step-by-step guide to obtaining CE Marking under the EU MDR, including classification, conformity assessment, Technical Documentation, Clinical Evaluation, Notified Body requirements and the CE certification process, read our CE Marking for Medical Devices Guide.
What Is the UKCA Mark?
UKCA (UK Conformity Assessed) marking is the conformity marking introduced by the United Kingdom following its departure from the European Union. It demonstrates that a medical device complies with the applicable UK legislation before being placed on the market in Great Britain (England, Scotland and Wales).
For medical devices, the applicable legislation is currently the Medical Devices Regulations 2002 (UK MDR 2002), as amended. These regulations are enforced by the Medicines and Healthcare products Regulatory Agency (MHRA), which acts as the UK’s competent authority for medical devices.
Like CE Marking, UKCA marking is intended to demonstrate that a medical device meets the essential regulatory requirements relating to safety, performance and quality. Depending on the classification of the device, manufacturers may need to undergo an independent conformity assessment by a UK Approved Body before applying the UKCA mark. Class I medical devices that are not sterile, measuring or reusable surgical instruments can generally be self-certified, provided all applicable regulatory requirements are met.
Manufacturers established outside the United Kingdom must also appoint a UK Responsible Person (UKRP) before placing most medical devices on the Great Britain market. The UK Responsible Person acts as the manufacturer’s representative within the UK and has defined responsibilities under the UK MDR, including assisting with device registration, maintaining regulatory documentation and acting as the primary contact with the MHRA.
Although UKCA marking was introduced to replace CE Marking in Great Britain, the UK Government has adopted transitional arrangements allowing many CE-marked medical devices to continue being placed on the Great Britain market until 30 June 2030. In addition, the Government is currently consulting on proposals to recognise CE-marked devices complying with the EU MDR and IVDR indefinitely. Until any legislative changes are confirmed, manufacturers should continue to comply with the existing transitional arrangements while planning their long-term regulatory strategy.
It is also important to recognise that Northern Ireland is subject to different regulatory arrangements. Medical devices placed on the Northern Ireland market generally continue to follow EU medical device legislation under the Windsor Framework, meaning CE Marking remains the primary conformity marking for that market.
The following comparison highlights the key similarities and differences between CE Marking and UKCA Marking, helping manufacturers determine which regulatory pathway is appropriate for their intended markets.
CE Marking vs UKCA Marking: Key Differences
Although CE Marking and UKCA marking both demonstrate that a medical device complies with applicable regulatory requirements, they are governed by different legislation and apply to different geographical markets. The table below summarises the key differences manufacturers should understand when planning market access.
| Requirement | CE Marking | UKCA Marking |
|---|---|---|
| Applicable legislation | Regulation (EU) 2017/745 (EU MDR) and Regulation (EU) 2017/746 (IVDR) | UK Medical Devices Regulations 2002 (UK MDR 2002), as amended |
| Primary regulator | Competent Authorities within EU Member States | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Conformity assessment body | EU Notified Body (where required) | UK Approved Body (where required) |
| Markets covered | European Economic Area (EEA) and other countries recognising CE Marking | Great Britain (England, Scotland and Wales) |
| Northern Ireland | CE Marking continues to apply under the Windsor Framework | UKCA marking is generally not used as the primary conformity marking |
| Manufacturer outside market | EU Authorised Representative required | UK Responsible Person required |
| Declaration of Conformity | EU Declaration of Conformity | UK Declaration of Conformity |
| Technical Documentation | Must comply with EU MDR or IVDR | Must comply with UK MDR requirements |
| Device registration | EUDAMED (when fully operational) and national registration where applicable | Registration with the MHRA |
| Current transition arrangements | Recognised throughout the EU and EEA | CE-marked devices are generally accepted in Great Britain until 30 June 2030 under current legislation |
For many manufacturers, choosing between CE Marking and UKCA marking is not an either-or decision. Businesses intending to sell medical devices in both the European Union and Great Britain will often need to comply with both regulatory systems. While much of the underlying technical evidence—such as risk management, clinical evaluation and technical documentation—may be shared, manufacturers will usually need to maintain separate regulatory documentation, appoint the appropriate representatives and ensure compliance with the requirements of each jurisdiction.
Understanding these differences early in product development helps avoid costly delays, duplicate work and regulatory issues when expanding into new markets.
Where Can CE Marking and UKCA Marking Be Used?
Choosing the correct conformity marking depends on where you intend to place your medical device on the market. Although CE Marking and UKCA marking serve similar purposes, they apply to different jurisdictions and are subject to different regulatory requirements.
CE Marking
CE Marking allows compliant medical devices to be placed on the market throughout the European Economic Area (EEA), including all European Union Member States as well as Iceland, Liechtenstein and Norway. Manufacturers wishing to sell devices in these countries must comply with the EU MDR or IVDR and, where applicable, obtain certification from an EU Notified Body.
Many countries outside Europe also recognise CE certification as evidence of compliance with internationally recognised regulatory standards, making CE Marking an important route for manufacturers seeking wider global market access.
UKCA Marking
UKCA marking is intended for medical devices placed on the market in Great Britain, comprising:
- England
- Scotland
- Wales
Medical devices placed on the Great Britain market must comply with the UK Medical Devices Regulations and, where required, undergo conformity assessment by a UK Approved Body.
However, under the current transitional arrangements, many CE-marked medical devices may continue to be placed on the Great Britain market until 30 June 2030, provided they meet the applicable eligibility criteria. Manufacturers should also be aware that the UK Government is considering proposals to continue recognising CE-marked devices beyond this date.
Northern Ireland
Northern Ireland follows different regulatory arrangements from Great Britain.
Under the Windsor Framework, medical devices placed on the Northern Ireland market generally continue to comply with EU medical device legislation. In most cases, CE Marking remains the appropriate conformity marking for products supplied in Northern Ireland.
Manufacturers should therefore consider Northern Ireland separately when planning their regulatory strategy, particularly if they intend to market devices across both Great Britain and the European Union.
Selling in Both the EU and Great Britain
Many manufacturers choose to market their medical devices throughout Europe and Great Britain. In these cases, a dual-market compliance strategy is often the most effective approach.
This may require manufacturers to:
- Maintain technical documentation that satisfies both regulatory frameworks.
- Appoint an EU Authorised Representative for the European market.
- Appoint a UK Responsible Person for the Great Britain market.
- Register devices with the MHRA where required.
- Maintain the appropriate Declaration(s) of Conformity.
- Ensure product labelling reflects the markets in which the device will be supplied.
Developing a coordinated regulatory strategy early in the product lifecycle can significantly reduce duplication, minimise regulatory risk and simplify future market expansion.
Current CE Marking and UKCA Transition Timeline
When UKCA marking was introduced following the UK’s departure from the European Union, it was intended to replace CE Marking for medical devices placed on the Great Britain market. However, to minimise disruption for manufacturers and ensure continuity of supply, the UK Government introduced a series of transitional arrangements allowing many CE-marked medical devices to continue being placed on the market in Great Britain.
Under the current legislation, many medical devices that comply with the EU MDR or EU IVDR may continue to be placed on the Great Britain market until 30 June 2030, provided they meet the relevant eligibility requirements. This has allowed manufacturers to continue using CE certification while preparing for future UK regulatory changes.
More recently, the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA) have consulted on proposals to indefinitely recognise CE-marked medical devices that comply with the EU MDR and IVDR. If implemented, this would remove the need for many manufacturers to obtain UKCA marking solely to maintain access to the Great Britain market.
Although these proposals have been welcomed by much of the medical device industry, they have not yet been formally implemented. Manufacturers should therefore continue to comply with the current transitional arrangements while monitoring future regulatory announcements from the MHRA.
What Should Manufacturers Do Now?
Until the UK Government confirms its long-term policy, manufacturers should adopt a proactive regulatory strategy rather than waiting until the transition period ends.
Good practice includes:
- Monitoring MHRA announcements for changes to UK medical device legislation.
- Ensuring Technical Documentation remains compliant with the latest EU MDR or IVDR requirements.
- Maintaining CE certification where required.
- Appointing a UK Responsible Person before placing applicable devices on the Great Britain market.
- Considering whether obtaining UKCA marking provides commercial or strategic benefits for long-term market access.
- Planning regulatory activities well in advance to avoid delays if future UKCA requirements are introduced.
Manufacturers supplying both the European Union and Great Britain should also ensure their regulatory strategy is reviewed regularly, particularly as UK legislation continues to evolve independently from the European Union.
While the long-term direction of UK medical device regulation is becoming clearer, organisations that maintain robust regulatory documentation and monitor legislative developments will be best placed to respond to any future changes with minimal disruption.
Which Regulatory Route Should Manufacturers Choose?
The appropriate regulatory pathway depends entirely on where you intend to market your medical device. Some manufacturers only require CE Marking, while others may benefit from maintaining compliance with both the EU and UK regulatory frameworks.
The following examples illustrate the most common scenarios.
Selling Only in the European Union
If your medical device will only be placed on the market within the European Economic Area (EEA), CE Marking is the appropriate conformity marking.
Manufacturers must comply with the applicable requirements of the EU MDR or IVDR, prepare compliant Technical Documentation, complete the necessary conformity assessment procedures and appoint an EU Authorised Representative if they are established outside the European Union.
Selling Only in Great Britain
Manufacturers supplying devices exclusively to England, Scotland and Wales should ensure they comply with the requirements of the UK Medical Devices Regulations.
Although many CE-marked medical devices are currently accepted in Great Britain under the existing transition arrangements, manufacturers should monitor MHRA guidance and consider whether obtaining UKCA marking aligns with their long-term commercial strategy.
Manufacturers established outside the UK must also appoint a UK Responsible Person before placing applicable devices on the Great Britain market.
Selling Throughout Europe and Great Britain
Many manufacturers choose to supply medical devices across both markets.
In these cases, maintaining compliance with both regulatory systems often provides the greatest commercial flexibility and reduces the risk of future market disruption.
A dual-market strategy may include:
- Maintaining Technical Documentation that satisfies both regulatory frameworks.
- Holding valid CE certification where required.
- Appointing both an EU Authorised Representative and a UK Responsible Person.
- Registering devices with the MHRA where applicable.
- Maintaining the appropriate Declaration(s) of Conformity.
- Ensuring labelling complies with the requirements of each market.
Although much of the underlying technical evidence can be shared between both regulatory systems, manufacturers should review any country-specific requirements before placing devices on either market.
Planning for the Future
The UK medical device regulatory framework continues to evolve. While the Government is consulting on proposals to recognise CE-marked devices indefinitely, manufacturers should avoid making long-term business decisions based solely on proposed legislation until it has been formally adopted.
Organisations that maintain robust Technical Documentation, effective Quality Management Systems and proactive regulatory planning are typically best placed to respond to future regulatory changes with minimal disruption.
By understanding the differences between CE Marking and UKCA marking and developing an appropriate regulatory strategy, manufacturers can continue to access key international markets while remaining compliant with both current and future legislation.
Common CE Marking and UKCA Compliance Mistakes
Although the differences between CE Marking and UKCA marking are becoming better understood, manufacturers still make a number of common regulatory mistakes that can delay product launches, create compliance issues or restrict access to key markets. Understanding these pitfalls can help organisations develop a more effective regulatory strategy from the outset.
Assuming CE Marking and UKCA Marking Are Identical
Although the two regulatory systems share many similarities, they are not interchangeable. CE Marking demonstrates compliance with European Union legislation, while UKCA marking demonstrates compliance with UK legislation. Manufacturers should ensure they understand the specific requirements of each regulatory framework before placing devices on the market.
Believing CE Marking Will Always Be Accepted in Great Britain
Many manufacturers assume that because CE-marked devices are currently recognised in Great Britain, no further planning is required.
While eligible CE-marked devices can generally continue to be placed on the Great Britain market until 30 June 2030, and the UK Government is consulting on proposals for indefinite recognition, manufacturers should continue monitoring MHRA guidance and avoid relying solely on proposed legislative changes until they are formally adopted.
Forgetting to Appoint the Correct Representative
Manufacturers established outside the European Union require an EU Authorised Representative before placing most medical devices on the EU market.
Similarly, manufacturers established outside the United Kingdom generally require a UK Responsible Person before placing applicable devices on the Great Britain market.
These are separate regulatory roles with different legal responsibilities and should not be confused.
Assuming One Declaration of Conformity Covers Both Markets
Manufacturers supplying both the European Union and Great Britain will often need to maintain separate Declarations of Conformity, reflecting the legislation applicable to each market.
Although much of the supporting technical evidence may be shared, the legal declarations should accurately reference the relevant regulatory framework.
Overlooking Labelling Requirements
Medical device labelling must accurately reflect the markets in which the device will be supplied.
This may include:
- CE Marking where applicable.
- UKCA marking where required.
- Details of the EU Authorised Representative.
- Details of the UK Responsible Person.
- Any additional regulatory information required under the applicable legislation.
Incorrect or incomplete labelling remains a common cause of regulatory non-conformities.
Delaying Regulatory Planning
Perhaps the most significant mistake is leaving regulatory planning until shortly before product launch.
Preparing Technical Documentation, completing Clinical Evaluation, obtaining conformity assessment where required and registering devices with the relevant authorities all require time. Manufacturers that build regulatory compliance into their product development process are far better positioned to achieve timely market access while avoiding unnecessary delays and costs.
By understanding these common pitfalls, manufacturers can develop a regulatory strategy that supports both compliance and long-term commercial success across the European and Great Britain markets.
Do You Need a UK Responsible Person?
If you're a manufacturer based outside Great Britain, appointing a UK Responsible Person (UKRP) is generally a legal requirement before placing medical devices on the Great Britain market. Learn who needs a UKRP, the legal responsibilities of the role, MHRA registration requirements and how Patient Guard can support your UK market access by reading our UK Responsible Person Guide.
Worked Example: Selling a Medical Device in Both the EU and Great Britain
To better understand how CE Marking and UKCA marking apply in practice, consider the following example.
Scenario
A manufacturer based in the United States has developed a new Class IIa infusion pump and intends to sell it throughout Germany, France, Italy, England, Scotland and Wales.
Because the company is established outside both the European Union and the United Kingdom, it must comply with the regulatory requirements for each market before the device can be placed on the market.
Step 1 – Obtain CE Marking
To access the European market, the manufacturer must comply with the requirements of the EU Medical Device Regulation (EU) 2017/745 (MDR).
This includes:
- Establishing and maintaining compliant Technical Documentation.
- Preparing a Clinical Evaluation.
- Completing Risk Management in accordance with ISO 14971.
- Implementing an appropriate Quality Management System.
- Undergoing conformity assessment by a Notified Body where required.
- Issuing an EU Declaration of Conformity.
Once conformity has been demonstrated, the manufacturer may affix the CE Mark and place the device on the European market.
Step 2 – Appoint an EU Authorised Representative
As the manufacturer is located outside the European Union, it must appoint an EU Authorised Representative (EU AR) before placing the device on the EU market.
The EU Authorised Representative acts on behalf of the manufacturer for specified regulatory responsibilities and serves as the primary contact for European Competent Authorities.
Step 3 – Access the Great Britain Market
The manufacturer also wishes to sell the device in England, Scotland and Wales.
Provided the device meets the applicable transition arrangements, an eligible CE-marked device may currently be placed on the Great Britain market without obtaining UKCA marking.
However, the manufacturer must still:
- Appoint a UK Responsible Person.
- Register the device with the MHRA.
- Ensure labelling complies with UK requirements.
- Maintain appropriate post-market surveillance activities.
The EU Authorised Representative acts on behalf of the manufacturer for specified regulatory responsibilities and serves as the primary contact for European Competent Authorities.
Step 4 – Plan for Future Regulatory Changes
Although the current transition arrangements allow many CE-marked devices to continue being supplied in Great Britain until 30 June 2030, the manufacturer should continue monitoring MHRA guidance and maintain a regulatory strategy that can adapt to future legislative developments.
By maintaining robust Technical Documentation and regulatory processes, the organisation can respond efficiently to changes while continuing to supply both the European Union and Great Britain.
Outcome
By following the appropriate regulatory pathway, the manufacturer is able to:
- Sell throughout the European Union using CE Marking.
- Supply Great Britain in accordance with current UK regulatory requirements.
- Maintain access to both markets through a coordinated regulatory strategy.
- Reduce duplication by using much of the same technical evidence to support compliance in both jurisdictions.
- Adapt more easily to future regulatory changes as UK legislation continues to evolve.
This example illustrates that, while CE Marking and UKCA marking have different legal foundations, manufacturers can often develop a single regulatory strategy that supports compliance across multiple markets while minimising unnecessary duplication of work.
Conclusion
Choosing between CE Marking and UKCA marking is not simply a question of applying the correct conformity mark—it requires manufacturers to understand the regulatory requirements of each market they intend to serve.
For organisations placing medical devices on the European Union market, CE Marking under the EU Medical Device Regulation (EU) 2017/745 (MDR) or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) remains the legal route to market. Manufacturers wishing to supply devices in Great Britain must also understand the requirements of the UK Medical Devices Regulations, the role of the MHRA, and the current transition arrangements for eligible CE-marked devices.
While many of the technical requirements are similar, successful market access depends on much more than meeting product performance requirements. Manufacturers should ensure they have robust Technical Documentation, appropriate clinical evidence, effective risk management, compliant labelling, post-market surveillance processes and the correct regulatory representatives in place before placing devices on the market.
As the UK regulatory framework continues to evolve, manufacturers should also monitor MHRA guidance and build flexibility into their regulatory strategy so they can respond efficiently to future legislative changes.
Whether you are launching your first medical device, expanding into new international markets or maintaining compliance across multiple jurisdictions, developing a well-planned regulatory strategy can reduce delays, minimise regulatory risk and support long-term commercial success.
If you need assistance with CE Marking, UKCA compliance, Technical Documentation, Clinical Evaluation, Quality Management Systems, EU Authorised Representative services or UK Responsible Person support, Patient Guard’s regulatory specialists can help you navigate the requirements and bring your medical devices to market with confidence.
Need Help Achieving CE Marking or UK Compliance?
Whether you're launching a new medical device or expanding into the European or Great Britain markets, Patient Guard can support every stage of the regulatory process. From classification and Technical Documentation to Clinical Evaluation, UK Responsible Person services and CE Marking, our consultants help manufacturers achieve and maintain compliance. Learn more about our CE Marking Consultancy Services.
Frequently Asked Questions
It depends on where you intend to sell your medical device. Devices placed on the European Union market generally require CE Marking under the EU MDR or IVDR. Devices placed on the Great Britain market must comply with the UK Medical Devices Regulations, although many eligible CE-marked devices continue to be accepted under the current transition arrangements.
Yes. Under the current transition arrangements, many CE-marked medical devices that comply with the EU MDR, IVDR or applicable Directives may continue to be placed on the Great Britain market until 30 June 2030, subject to the applicable conditions. Manufacturers should continue monitoring MHRA guidance, as the UK Government is consulting on proposals for indefinite recognition of eligible CE-marked devices.
Not within the European Union. CE Marking remains mandatory for placing medical devices on the EU market. UKCA marking was introduced as the UK’s conformity marking following Brexit, but current UK legislation continues to recognise many CE-marked medical devices during the transition period while future regulatory reforms are being considered.
In many cases, yes. Much of the Technical Documentation, including risk management, clinical evidence, verification and validation data, can support compliance with both regulatory systems. However, manufacturers should ensure that declarations, registrations, labelling and any market-specific requirements are addressed separately where necessary.
If you are established outside both the European Union and Great Britain and intend to sell in both markets, the answer is generally yes. An EU Authorised Representative is required for placing most devices on the EU market, while a UK Responsible Person is required for placing applicable devices on the Great Britain market.
No, in most cases. Under the Windsor Framework, medical devices placed on the Northern Ireland market generally continue to follow the relevant European Union rules. Manufacturers should ensure they understand the specific requirements that apply to Northern Ireland before placing products on the market.
Although both act on behalf of manufacturers established outside the relevant jurisdiction, they operate under different legislation and have different legal responsibilities. An EU Authorised Representative acts under the EU MDR or IVDR, while a UK Responsible Person fulfils equivalent responsibilities under the UK Medical Devices Regulations for the Great Britain market.
No. Whether third-party conformity assessment is required depends on the classification of the medical device. Many higher-risk devices require assessment by a Notified Body (EU) or UK Approved Body (Great Britain), whereas most Class I medical devices that are not supplied sterile, with a measuring function or reusable surgical instruments may be self-certified by the manufacturer.
Current legislation allows many eligible CE-marked medical devices to continue being placed on the Great Britain market until 30 June 2030. Beyond this date, the regulatory requirements will depend on the final outcome of the UK Government’s medical device reforms and any future legislation. Manufacturers should continue following current requirements while monitoring MHRA updates.
The timeframe depends on several factors, including the classification of the medical device, the completeness of the Technical Documentation, whether Clinical Evaluation or Performance Evaluation is required, and whether assessment by a Notified Body or UK Approved Body is necessary. For lower-risk devices, the process may take a few months, while higher-risk devices requiring third-party assessment can take considerably longer.
Yes. Patient Guard provides end-to-end regulatory support for medical device manufacturers, including regulatory strategy, device classification, Technical Documentation, Clinical Evaluation, Biological Evaluation, Risk Management (ISO 14971), ISO 13485 Quality Management Systems, CE Marking consultancy, UK Responsible Person services and EU Authorised Representative services, helping manufacturers achieve and maintain compliance across both the European Union and Great Britain markets.
References
This guide is based on the following legislation and official regulatory guidance relating to CE marking under the European Medical Devices Regulation (MDR) and UKCA marking under the UK Medical Devices Regulations.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Provides the legal framework governing CE marking, conformity assessment, technical documentation and the placing of medical devices on the European Union market. |
| Medicines and Healthcare products Regulatory Agency (MHRA) | Medical Devices: Conformity Assessment and the UKCA Mark | Explains the UKCA conformity assessment process, the role of UK Approved Bodies, Declaration of Conformity requirements and the differences between Great Britain and Northern Ireland. |
| UK Government | Placing UKCA or CE Marked Products on the Market in Great Britain | Provides the latest UK Government guidance on placing UKCA and CE marked products on the Great Britain market, including conformity assessment procedures, documentation, marking requirements and current transitional arrangements. |
| Medicines and Healthcare products Regulatory Agency (MHRA) | Approved Bodies for Medical Devices | Lists the UK Approved Bodies authorised to carry out conformity assessment and issue UKCA certification for medical devices placed on the Great Britain market. |
| European Commission | Notified Bodies for Medical Devices | Provides official information on the role of EU Notified Bodies responsible for assessing conformity and issuing CE certificates for medical devices placed on the European Union market. |
Medical device regulation in both the European Union and the United Kingdom continues to evolve. Manufacturers should always consult the latest published legislation and official guidance when determining whether CE marking, UKCA marking or both are required for their products and target markets.
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