UKCA Marking Consultant for Medical Devices and IVDs in UK
UKCA Marking Consultant for Medical Devices and IVDs in the 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 is UKCA Marking for Medical Devices?
The UKCA (United Kingdom Conformity Assessment) marking indicates that a medical device complies with the UK MDR 2002 requirements. This mark ensures that the device is safe, fit for its intended purpose, and adheres to UK safety legislation. It is mandatory for medical devices intended for the Great Britain market, covering England, Wales, and Scotland.
UK MDR 2002
Learn more about UK regulations by visiting GOV.UK Guidance on Regulating Medical Devices and IVDs in the United Kingdom.
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Simplify Your UKCA Market Entry for Medical Devices
The UKCA marking signifies that a product meets the Essential Requirements (ER) of the UK MDR 2002, as amended. It is crucial for placing medical devices in the Great Britain market.
Key Steps for UKCA Marking:
- Classification: Determine your device’s classification under the UK MDR 2002.
- Conformity Assessment: Select the appropriate conformity assessment route to demonstrate compliance.
- Technical Documentation: Prepare comprehensive technical documentation, including device descriptions, intended use, and clinical data.
- Application Submission: Submit your application through the Medical Devices Information System (MDIS) to the MHRA.
- Evaluation: The MHRA evaluates your documentation to confirm compliance with safety and performance standards.
- Registration Certificate: Upon approval, the MHRA issues a registration certificate, enabling you to market your device in the UK
Also Read: Guide to MHRA medical device registration
UKCA Marking Timelines
January 2021 – June 2025: Medical Devices and IVDs can be marked with either CE or UKCA.
From July 2025: Legislative transitional arrangements will apply for devices marked with CE or UKCA in Great Britain.
Note: These timelines may change with new UK regulations post-parliamentary approval.
For Northern Ireland, a CE or UKNI mark is required for medical devices on the NI market, complying with EU Regulations. Based on MHRA acceptance of (EU) 2023/607, the following apply:
- Class III and IIb implantable non-WET devices: Until December 2027.
- Class IIb WET, Class IIa, Class Im, and Is devices: Until June 2028.
For more detailed guidance, please refer to the information available on the UK Government website.
How Operon Strategist Can Help with UKCA Marking for Medical Devices
Operon Strategist specializes in guiding medical device manufacturers, distributors, and importers through the UKCA marking process. Our services include:
- Comprehensive Assessments: Detailed review of your product’s compliance.
- Strategic Advice: Tailored strategies to navigate UK regulations.
- Regulatory Support: Assistance with documentation and MHRA liaison.
- Timely Compliance: Ensuring your devices meet UK standards for market entry.
Contact Operon Strategist Today to start your journey to UKCA marking for medical devices. Let us streamline your process and help you achieve compliance with ease.