UKCA Marking Consultant for Medical Devices in Brazil
UKCA Certification Support for Brazilian Manufacturers
With the UK’s exit from the European Union, the UKCA for Medical Devices (UK Conformity Assessed) marking has become mandatory for all medical devices placed on the market in Great Britain (England, Scotland, and Wales). If you are a Brazilian medical device manufacturer or exporter aiming to access the UK market, obtaining UKCA certification in compliance with UK MDR 2002 is essential. At Operon Strategist, we provide end-to-end UKCA consulting services in Brazil to help manufacturers achieve UKCA approval and full compliance with MHRA regulations—avoiding delays and ensuring a smooth market entry.
What is UKCA Marking for Medical Devices?
The UKCA (United Kingdom Conformity Assessment) marking is a mandatory logo indicating that a medical device complies with UK MDR 2002 safety and performance requirements.
It confirms that the device is:
- Safe for use
- Fit for its intended medical purpose
- In full compliance with UK legislation
Since June 30, 2024, UKCA compliance has been compulsory for medical devices sold in Great Britain.
UKCA Marking Process (Step-by-Step)
Device Classification – Determine classification under UK MDR 2002
Conformity Assessment – Verify compliance with safety and performance requirements
Technical Documentation – Prepare device description, risk management, clinical data, and intended use
Application Submission – File documents through MHRA’s Medical Devices Information System (MDIS)
MHRA Review – Regulatory assessment of compliance and documentation
Registration Certificate – Issued upon approval, authorizing your device for UK market access
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Who Needs UKCA Marking?
If you are part of the Brazilian medical device industry and plan to export to the UK, you must obtain UKCA certification. This includes:
- Brazilian manufacturers producing medical devices or IVDs for the UK market
- Exporters/importers shipping Brazilian medical devices to the UK
- Distributors handling devices within the UK market
- Non-UK manufacturers, who must appoint a UK Responsible Person (UKRP)
Key Requirements for UK Market Access
To legally place your medical devices in the UK, you must ensure:
- UKCA Marking – Mandatory on all products sold in Great Britain
- MHRA Registration – All medical devices and IVDs must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA)
- UK Responsible Person (UKRP) – Required for Brazilian manufacturers outside the UK
- Device Classification – Devices categorized as Class I, IIa, IIb, or III based on risk level
UKCA vs CE Marking – Key Differences
| Feature | UKCA Marking (Brazil Export) | CE Marking |
|---|---|---|
| Region of Application | Great Britain (England, Scotland, Wales) | European Union (EU), EEA, others |
| Regulatory Authority | MHRA (UK) | EU Notified Bodies |
| Governing Regulation | UK MDR 2002 | EU MDR 2017/745 |
| Accepted in EU Market | ❌ No | ✅ Yes |
| UK Responsible Person | ✅ Required | ❌ Not required |
MHRA Registration and UKCA Marking
MHRA (The Medicines and Healthcare Products Regulatory Agency) is the medical device regulatory body for the UK medical device market. To place a medical device in Great Britain’s market key requirements are as follows:
- New product marking (UKCA mark) is available.
- Medical devices and IVDs need to be registered with MHRA before being placed on the market.
- If a manufacturer is outside of the UK, then he/she needs to appoint a single UK-responsible person.
- CE marking will be continued till June 30, 2024.
The medical devices in the UK are classified as Class I, Class IIa, Class IIb, and Class III the way the European Union classifies the devices. Class I Medical devices are low-risk devices whereas class III devices are high-risk medical devices.
MHRA Registration Process
- Legal entity name and address
- Company Type
- Administrative Contact
- Class of the device
- UDI-DI if applicable
- Medical device name
They may request further technical documentation as part of the scrutiny and data validation process. You can also refer UK government website for more info. The timeline of the medical device registration process will depend upon the class of the device. MHRA allows medical device manufacturers to register their devices via DORS (device online registration system).
Medical devices entering Northern Ireland need to register themselves with MHRA UK and need to follow the EU market requirements of MDR or IVDR. From January 1, 2021, the new UKCA (United Kingdom Conformity Assessments ) Enters a transitional duration for devices getting into the UK market.
Take Your Brazilian Medical Devices to the UK Market with Confidence!
Why Choose Operon Strategist in Brazil?
Operon Strategist has deep expertise in helping Brazilian medical device manufacturers achieve UKCA compliance. Our services include:
- Regulatory Guidance – Step-by-step consulting on MHRA and UKCA requirements
- Gap Analysis – Identifying compliance gaps and ensuring quick fixes
- Technical Documentation Support – Assistance with conformity assessment files and submissions
- UK Responsible Person (UKRP) Coordination – Helping Brazilian exporters appoint and manage a UK Responsible Person
- Faster Market Access – Enabling smooth entry into the UK medical device market with UKCA approval
FAQs
What is UKCA certification for medical devices?
UKCA (UK Conformity Assessed) is the new product marking required for medical devices placed on the UK market after Brexit. It replaces CE marking for Great Britain. Brazilian manufacturers must obtain UKCA certification to legally sell their devices in the UK.
Do Brazilian medical device manufacturers still need CE marking for the UK?
No, CE marking is no longer valid in Great Britain. Instead, UKCA marking is mandatory. However, CE marking is still required for the EU market, while UKCA approval applies to England, Scotland, and Wales.
What are the key requirements for UKCA approval?
The main requirements include compliance with UK Medical Device Regulations (UK MDR 2002), classification of the device, technical documentation, and conformity assessment by a UK-approved body. Our experts guide Brazilian manufacturers through the entire UKCA approval process.
How long does it take to obtain UKCA certification for medical devices?
The timeline varies depending on device classification and supporting documents. On average, UKCA certification can take 3–6 months. Operon Strategist ensures a smooth and faster approval process for Brazilian companies.
How can Operon Strategist help Brazilian manufacturers with UKCA marking?
Operon Strategist provides end-to-end consulting services, including regulatory strategy, technical file preparation, and liaison with UK-approved bodies. We simplify the UKCA registration process, helping Brazilian manufacturers achieve faster market entry into the UK.