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.
Why Choose Operon Strategist for UKCA Marking for Medical Devices?
Operon Strategist is your trusted regulatory consultant for obtaining UKCA marking for medical devices. Our expert team simplifies the complex MHRA medical device registration process, ensuring your product meets all UKCA requirements for seamless market entry in Great Britain.
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Who Needs UKCA Marking for Medical Devices?
You need UKCA marking if you are:
- A UK-based medical device manufacturer
- A distributor of medical devices in the UK
- An importer of medical devices into the UK
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.
MHRA Medical Device Registration Process for UKCA Marking
The MHRA oversees medical device registration in the UK. Here’s how the process works:
- Device Classification: Determine the medical device classification based on MHRA regulations.
- Conformity Assessment: Conduct assessments to verify the device’s compliance with safety and performance standards.
- Technical Documentation: Compile detailed technical documentation, including clinical data and intended use descriptions.
- Application Submission: Submit the application through the Medical Devices Information System (MDIS).
- Evaluation by MHRA: MHRA reviews the submission for regulatory compliance.
- Registration Certificate Issuance: Upon approval, receive a registration certificate for UK market entry.
Also Read: Guide to MHRA medical device registration
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.
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.