UKCA Marking Consultant for Medical Devices and IVDs in UK
Achieving UKCA Marking is essential for medical device compliance in the UK. Operon Strategist provides specialized support to streamline the MHRA registration process, ensuring your product meets regulatory standards for market entry.
What UKCA marking means for medical devices?
UKCA stands for UK Conformity Assessed. It replaces CE marking for medical devices placed on the Great Britain market following Brexit. Devices that require UKCA marking must comply with the UK MDR 2002, which currently mirrors many EU MDR principles but is regulated separately by the MHRA.
UKCA marking applies to most:
- General medical devices
- Active medical devices
- In vitro diagnostic medical devices
Northern Ireland follows different rules under the UK NI framework, which is assessed separately.
Who Needs UKCA Marking for Medical Devices?
You need UKCA marking if you are:
- A UK manufacturer placing medical devices on the GB market
- A non UK manufacturer selling devices in Great Britain
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- An importer or distributor responsible for placing devices on the GB market
Non UK manufacturers must appoint a UK Responsible Person to legally place devices on the GB market.
Key UKCA Requirements for Medical Devices
- UKCA Mark on the Device: Ensure your medical device displays the UKCA mark.
- MHRA Medical Device Registration: Register all devices with the Medicines and Healthcare Products Regulatory Agency (MHRA).
- UK Responsible Person Registration: If you are a non-UK manufacturer, appoint a UK Responsible Person.
- Device Classification: Classify devices into Class I, IIa, IIb, or III based on risk, following MHRA medical device classification guidelines.
UKCA conformity assessment and MHRA registration
The UKCA process depends on your device classification and risk level.
Low risk devices may follow a self declaration route, while higher risk devices require conformity assessment by an approved UK body.
Key steps typically include:
- Device classification under UK MDR 2002
- Preparation or review of technical documentation
- Risk management and clinical evaluation
- Conformity assessment route selection
- Declaration of conformity
- MHRA device registration via the MDIS system
Each step must be completed accurately to avoid MHRA queries or rejection.
Also Read: Guide to MHRA medical device registration
UK Responsible Person requirements
If your manufacturing entity is based outside the UK, appointing a UK Responsible Person is mandatory.
The UK Responsible Person:
- Acts as your local regulatory contact with the MHRA
- Holds copies of technical documentation
- Supports incident reporting and field safety actions
- Ensures compliance obligations are met in the UK
Choosing the right UK Responsible Person is critical for long term market access.
UKCA vs CE marking
Although UKCA and CE marking share similar regulatory foundations, they are not interchangeable.
UKCA marking:
- Applies to Great Britain
- Is governed by UK MDR 2002
- Requires MHRA registration
CE marking:
- Applies to the EU market
- Is governed by EU MDR and IVDR
- Requires EU notified body involvement where applicable
Some transition provisions still exist, but manufacturers should plan UKCA compliance proactively to avoid disruption.
Important UKCA Medical Device Regulations to Remember
- Devices must be UKCA marked after June 30, 2024, for the Great Britain market.
- CE-marked devices will be accepted only until June 30, 2024.
- UK Responsible Person registration is mandatory for non-UK manufacturers.
- Devices placed on the Northern Ireland market can continue using CE marking after June 30, 2024.
Simplify UKCA Medical Device Registration with Expert Guidance from Operon Strategist!
How Operon Strategist Helps with UKCA Medical Device Registration
- Regulatory Guidance: Comprehensive UKCA regulatory consulting, including MHRA device registration requirements.
- Gap Analysis: Identifying and resolving compliance gaps.
- Compliance Support: Assistance with technical documentation, conformity assessments, and MHRA application submissions.
- Market Entry Success: Ensuring full compliance with UKCA medical device regulations for a successful product launch.
Ready for UKCA Marking for Medical Devices? Contact Operon Strategist today for expert guidance on MHRA medical device registration, UKCA medical device classification, and seamless entry into the UK market. Let us simplify the UKCA marking process for your medical devices.
FAQs
In many cases, yes. CE marking alone is not sufficient for placing devices on the Great Britain market. UKCA requirements must be assessed separately.
Timelines depend on device class, documentation readiness, and assessment route. Early planning reduces delays.
Yes. All medical devices placed on the GB market must be registered with the MHRA before supply.
Simplify Your UKCA Marking Process
With 12+ years of expertise and 200+ successful certifications, we handle everything—compliance, technical documentation, and MHRA approvals. Let us save your time and streamline the UKCA marking process for your medical devices.