GPSR
Compliance
For Book
Publishers
- Suvitha is a Regulatory Compliance Expert and Content Strategist with a deep understanding of UK and EU regulatory frameworks. At Euverify, she transforms complex legal and technical updates into clear, actionable guidance for businesses. Her work bridges regulation and communication, helping brands stay compliant, credible, and competitive in regulated markets.
- November 11, 2025Guides & TutorialsBlack Friday & Cyber Monday Compliance Checklist: Selling Safely in the EU & UK
- October 17, 2025Regulatory FrameworkEU & UK Compliance and Regulations for Winter Accessories: Scarves, Wraps, Gloves & Mittens
- September 30, 2025Industry InsightsHow to Avoid Bans on Construction Products in the UK & EU
- September 10, 2025Industry InsightsWhy Aren’t Menstrual Products Classified as Medical Devices in the EU? (Feminine Hygiene Rules Explained)
How to Achieve CE and UKCA Marking for Class I Medical Devices
If you manufacture, import, or distribute Class I medical devices in the EU or UK, understanding CE and UKCA marking is essential. These markings are your regulatory gateway, showing that your devices meet the necessary safety, performance, and legal standards.
Since Brexit, the regulatory paths have diverged. CE marking remains key for the European market, while the UKCA mark now applies in Great Britain, covering England, Wales, and Scotland.
This guide breaks down what CE and UKCA marking actually mean, how the rules apply to Class I devices, and the steps you need to follow. It also highlights common mistakes and key regulatory changes to watch for. Whether you’re launching a new device or adapting to post-Brexit regulations, this blog will help you make sense of the changes and move forward with clarity.
What Is CE Marking for Class 1 Medical Devices
CE marking stands for “Conformité Européenne,” or “European Conformity.” But it’s more than just a symbol. It’s the manufacturer’s legal declaration that their device meets all relevant EU regulatory standards under Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR). For Class I devices, CE marking shows that the product has been safely designed, manufactured, and documented according to strict EU health, safety, and performance requirements. Once approved, it allows the device to be legally sold across the European Economic Area, which includes all 27 EU countries, plus Iceland, Liechtenstein, and Norway.
What CE Marking Represents for Class I Devices
To affix the CE mark, manufacturers need to complete a set of compliance steps that show their product meets the General Safety and Performance Requirements (GSPRs) outlined in Annex I of the MDR. These include:
- Safety and risk control: All risks must be reduced as far as possible and must be outweighed by the benefits of device use.
- Clinical performance: The device must achieve its intended purpose without causing harm.
- Chemical, biological, and physical safety: Materials used must not present unacceptable risks to patients or users.
- Labelling and instructions for use (IFU) must be clear, consistent, and compliant.
- Post-market surveillance (PMS) and clinical evaluation must be planned and documented—even for Class I.
Manufacturers also need to create and maintain clear technical documentation that proves their device meets all requirements. This file must stay up to date and be ready to share with EU regulators if requested, even after the product is on the market.
Is a Notified Body Required?
No, not for standard Class I devices. One of the advantages of this classification is that manufacturers can usually self-certify and apply the CE mark on their own, without needing a Notified Body.
However, there are exceptions:
- If your device is sterile (Class Is)
- If it has a measuring function (Class Im)
- Or if it’s a reusable surgical instrument (Class Ir)
In that case, you’ll need to involve a Notified Body, but only for the specific aspect that requires extra scrutiny, such as the sterilisation process or measurement accuracy.
Who Needs CE Marking?
Any company placing a Class I medical device on the market in the EU or EEA must obtain CE marking, whether you’re a manufacturer, importer, or distributor.
- A manufacturer based in the EU
- A non-EU manufacturer exporting to Europe
- An importer bringing third-party devices into the EU market
If you’re based outside the EU, you’ll also need to appoint an EU Authorised Representative (EU AR). They act as your official contact for EU authorities and make sure your documentation is always accessible within the EU.
CE marking isn’t just a formality. It’s your ticket into the European market and a sign to regulators, healthcare professionals, and patients that your Class I device is safe, effective, and fully compliant.
What Is UKCA Marking for Class 1 Medical Devices
UKCA marking (UK Conformity Assessed) is the UK’s post-Brexit equivalent of the CE mark. It’s a required label for medical devices sold in Great Britain, meaning England, Wales, and Scotland, and it shows that the device meets the safety, performance, and labelling standards set by UK law.
UKCA is regulated under the UK Medical Devices Regulations 2002 (as amended). These rules are still closely based on the old EU Medical Devices Directive, but the gap between the two is gradually growing.
Why UKCA Marking Matters
Just like CE marking in the EU, UKCA marking is a legal declaration that your Class I device meets all relevant UK regulatory requirements. It tells the Medicines and Healthcare products Regulatory Agency (MHRA) that your device is safe, compliant, and ready for the market in Great Britain.
Without the UKCA mark, you can’t sell, supply, or distribute your device in the UK — unless it’s still within the transition period where CE marking is temporarily allowed.
The CE-UKCA Transition Period: Where Are We Now?
As of now (August 2025), CE marking for medical devices is still accepted in Great Britain until 30 June 2028, following a government extension. However, after this date:
- UKCA marking becomes mandatory for all medical devices in GB.
- Devices relying solely on CE marking will no longer be marketable in GB.
This means manufacturers should start preparing for UKCA compliance now to avoid regulatory bottlenecks or market disruption after the transition.
It’s important to note that UKCA marking does not apply in Northern Ireland, which continues to follow EU law under the Northern Ireland Protocol. Devices sold there must carry either the CE mark or the CE mark combined with UK(NI), depending on the conformity route.
Who Needs UKCA Marking?
If you manufacture, import, or distribute Class I medical devices for the Great Britain market, you need UKCA marking. This includes:
- UK-based manufacturers
- Manufacturers based outside the UK who export to Great Britain
- Importers bringing products into Great Britain from the EU or other regions
If your business is based outside the UK, you must also appoint a UK Responsible Person (UKRP) to represent you in regulatory matters and act as your official point of contact.
What the UKCA Mark Represents
To legally apply the UKCA mark to a Class I medical device, manufacturers must:
- Ensure the device meets the UK MDR 2002 (as amended)
- Prepare a compliant technical file
- Draft and sign a UK Declaration of Conformity
- Register the device with the MHRA before it enters the GB market
- Ensure proper labeling and IFU requirements are met (English-only required)
For basic Class I devices that are non-sterile, non-measuring, and not reusable surgical, self-declaration is allowed, similar to the EU system. However, if your Class I device falls under the Is, Im, or Ir subcategories, you must involve a UK Approved Body to assess the relevant aspect, such as sterility or measurement function.
MHRA Registration Requirement
All medical devices, including Class I, must be registered with the MHRA before they are placed on the market in Great Britain. Unlike the EU’s EUDAMED system, which is still being rolled out, MHRA registration is already mandatory.
To register, you will need:
- Manufacturer details
- UK Responsible Person (if applicable)
- UDI information (if applicable)
- Device description and classification
Registration must be completed through the MHRA’s Device Online Registration System (DORS).
UK Responsible Person (UKRP): Your Regulatory Link
If you’re not based in the UK, you must designate a UKRP who will:
- Act on your behalf in regulatory dealings with MHRA
- Keep a copy of your technical documentation
- Cooperate with MHRA inspections or requests
- Ensure proper labeling, UDI, and conformity markings are in place
The UKRP’s name and contact details must appear on the device labelling, outer packaging, or instructions for use.
Labelling Requirements for UKCA Marking
Devices must display:
- The UKCA logo (at minimum 5mm high)
- Manufacturer details (name and UK address or UKRP)
- Product name, serial number, or UDI
- Any warnings or precautions
- Instructions for use in English only
Dual-labelling with CE and UKCA is allowed until 30 June 2028. But labeling must be clear, non-conflicting, and jurisdiction-specific.
CE vs. UKCA: What’s the Difference for Class I Medical Devices?
While CE and UKCA markings serve a similar purpose in demonstrating that a medical device meets regulatory requirements, they are not interchangeable. The compliance routes, regulatory authorities, and representation obligations are different in each case. For CE marking, devices must comply with EU MDR 2017/745, under the oversight of Notified Bodies (where applicable) and the European Commission. UKCA marking, on the other hand, is based on the UK MDR 2002 and is enforced by the MHRA in Great Britain.
Both frameworks require technical documentation, a Declaration of Conformity, and proper labelling, although there are some key differences. For instance, devices intended for the EU market may need multilingual Instructions for Use (IFU), while the UK requires labelling in English only. Manufacturers based outside the EU must appoint an EU Authorised Representative, while those outside the UK are required to appoint a UK Responsible Person (UKRP). These roles are similar in function, serving as the manufacturer’s regulatory contact, but each must be established within their respective region.
In addition, CE marking allows free circulation of devices across the European Economic Area, whereas the UKCA mark applies only within Great Britain, which includes England, Scotland, and Wales. Northern Ireland continues to follow EU rules, so CE marking remains valid there. Understanding these regional differences is essential to maintain uninterrupted market access across both jurisdictions.
How to CE Mark a Class I Medical Device
Step 1: Determine Classification
Confirm that your device is truly classified as Class I under MDR Annex VIII. If it is sterile (Is), has a measuring function (Im), or is a reusable surgical instrument (Ir), involvement from a Notified Body is required for those specific aspects.
Step 2: Prepare Technical Documentation
Include:
- Device description
- Risk management (ISO 14971:2019)
- Clinical evaluation (Annex XIV)
- GSPR checklist (Annex I)
- PMS and vigilance procedures
- Labelling and IFU
Step 3: Draft the Declaration of Conformity
This self-declaration states your product complies with all applicable regulations and standards. Keep it updated.
Step 4: Apply the CE Mark
- Place the CE logo visibly on the device, packaging, and IFU.
- Add the Notified Body number if applicable.
Step 5: Register in EUDAMED
Though not mandatory yet for Class I, EUDAMED registration is strongly encouraged to future-proof your compliance.
How to UKCA Mark a Class I Medical Devices
Step 1: Classify the Device
Use UK MDR rules (mirroring MDD classification structure). Ensure Class I status is accurate.
Step 2: Appoint a UK Responsible Person (UKRP)
If you’re not based in the UK, your UKRP must:
- Register your devices with the MHRA
- Hold your technical documentation
- Serve as your regulatory contact
Step 3: Register with the MHRA
MHRA registration is mandatory for Class I devices. You must:
- Submit information about the device and manufacturer
- Receive confirmation before placing it on the GB market
Step 4: Draft UK Declaration of Conformity
Similar to the EU version, but must cite UK MDR and include UKRP details.
Step 5: Apply the UKCA Mark
Place the UKCA symbol on the device, IFU, and outer packaging. From July 2028, this is the only mark accepted in Great Britain.
Dual Marking: Can a Medical Device Have Both CE and UKCA?
Although the EU and UK have followed separate regulatory paths since Brexit, their technical requirements for Class I devices remain largely aligned, at least for now. This gives manufacturers an opportunity to streamline operations by preparing one version of the device, one set of labels, and two Declarations of Conformity to meet both sets of requirements.
Key Benefits of Dual Marking:
- Single manufacturing run: Avoid the need to produce different versions of the same product for each region. This simplifies inventory management, labelling, and distribution.
- Reduced compliance risk: Being prepared for both systems helps you stay compliant if either market changes its rules unexpectedly, such as increased MHRA enforcement or the full rollout of EUDAMED.
- Simplified logistics: Distributors, importers, and warehouse partners can handle one version of the product, reducing complexity across the supply chain.
- Extended market reach: Dual marking supports seamless placement in the European Economic Area, Great Britain, and often Northern Ireland, where CE or CE plus UK(NI) marking is required.
- Future-proofing: As EU and UK regulations continue to diverge after 2025, dual marking gives you greater flexibility without needing a complete revalidation later.
Dual Labelling Rules for Class 1 Medical Devices: What You Must Do
Dual marking is not just about putting two logos on the packaging. Each mark must be backed by a fully compliant regulatory pathway, including separate legal declarations and representation arrangements for the EU and the UK.
You must ensure:
- Both marks are applied correctly
- Use the CE and UKCA logos as prescribed (minimum size, visibility, and format).
- Place them on the device, packaging, and Instructions for Use (IFU).
- If applicable, add the Notified Body (NB) number next to the CE mark and the Approved Body (AB) number next to the UKCA mark.
- Both Declarations of Conformity are maintained
- Create and maintain two distinct Declarations. One referencing EU MDR (2017/745) and the other referencing UK MDR 2002 (as amended).
- Each declaration must cite the relevant standards and include applicable representative details (EU AR or UKRP).
- Representative details are clear and non-conflicting
- List the EU Authorised Representative (AR) for CE marking and the UK Responsible Person (UKRP) for UKCA marking.
- These roles must be identified clearly and must not be substituted or shared across jurisdictions.
- Contact addresses must be valid and accessible for competent authorities.
- Instructions for Use (IFU) are compliant in both regions
- CE requires multilingual IFUs, depending on target EU countries.
- UKCA requires English-only IFUs for Great Britain.
- Ensure the IFU reflects both marking systems where appropriate, without contradictions.
Dual Marking Pitfalls — and How to Design Around Them
While dual marking offers efficiency, it is also a common source of regulatory mistakes. Here are the most frequent pitfalls and how smart labelling strategies can help you avoid them:
Common Mistakes to Avoid:
- Applying only one mark and assuming it covers both markets. It does not. CE and UKCA are distinct legal declarations.
- Using a single Declaration of Conformity for both marks without referencing the correct regulation, such as EU MDR or UK MDR 2002.
- Omitting the UK Responsible Person (UKRP) or EU Authorised Representative (AR) when required. These are legal necessities for non-UK and non-EU manufacturers, respectively.
- Using confusing or overlapping logos, or placing both marks without clear jurisdictional separation. This can mislead regulators or lead to enforcement action.
Smart Solution: Design With Flexibility
To avoid these mistakes and future-proof your materials, many manufacturers are adopting modular or dual-compliant labelling systems, such as:
- A single label or IFU that clearly shows both the CE and UKCA marks, each tied to the correct representative and declaration.
- Dedicated sections for EU and UK compliance information, ensuring clarity and avoiding contradiction.
- Use of QR codes or short URLs linking to downloadable Declarations of Conformity or regulatory contacts. This keeps packaging clean while meeting traceability requirements.
By building flexibility into your labelling and documentation now, you reduce rework during regulatory updates and ensure you are audit-ready in both markets.
Common Pitfalls in Class 1 Medical Device Compliance and How to Avoid Them
One of the most common issues Class I manufacturers face is misclassifying their devices. Misunderstanding whether a product is Class Is, Im, or Ir can lead to serious compliance gaps and even illegal market entry. To avoid this, it’s essential to carefully review the MDR classification rules and, when in doubt, seek expert regulatory advice early in the process.
Another frequent problem is failing to appoint an EU Authorised Representative (AR) or UK Responsible Person (UKRP) when required. For companies based outside the EU or UK, lacking proper representation means your devices cannot legally be placed on the market. Partnering with a trusted, experienced representative ensures compliance and smooth regulatory interactions.
Labelling errors are also a frequent source of trouble. Mistakes such as using only CE or UKCA marking when both are required, omitting key symbols, or failing to include proper warnings can lead to non-compliance or product recalls. Staying aligned with MDR Annex I and MHRA labelling guidance helps keep packaging and IFUs correct and compliant.
Lastly, registration delays can block market access altogether. Both EUDAMED (in the EU) and MHRA’s system (in the UK) are critical, and failing to register in time can stop sales before they even start. Proactively managing device registrations and monitoring regulatory updates is key to avoiding last-minute surprises.
By tackling these pitfalls early through proper classification, representation, labelling, and registration, you can streamline compliance and avoid costly setbacks.
Final Thoughts: Don’t Treat CE and UKCA as Formalities
Staying compliant in both the EU and UK markets may seem complex, but with the right strategy, it becomes manageable. Start by properly classifying your medical device and appointing the correct representative. Ensure your documentation, labelling, and registration are accurate and up to date. This helps you avoid delays, reduce risk, and stay ahead of regulatory changes. Whether you’re working with CE or UKCA marking, EUDAMED or MHRA systems, a proactive and informed approach will keep your Class I devices compliant and ready for the market.
Practical Guide to Clothing, Apparels, and Textile Compliance in the UK & EU
A helpful guide that provides a comprehensive overview of compliance for Clothing, Apparels, and Textiles.
Technical Files Checklist & Risk Assessment Template
For Clothing, Apparels, and Textiles
- Ensure Compliance
- Reduce Risk
- Streamline Documentation
- Supports market access
Get it now for just £40!
Appoint Your EU Representative & Ensure Compliance for Your Clothing, Apparels, and Textile
- Stay compliant with EU regulations
- Hassle-free representation for Clothing, Apparels, and Textiles
CE, medical devices, UKCA
Related Resources
Compliance
Guides & Tutorials
Cosmetics
Industry Insights
GPSR
Regulatory Framework
GDPR
Regulatory Framework
Cosmetics
Industry Insights
