UKCA Marking Consultant for Medical Devices
Operon Strategist is your go-to regulatory consultant for obtaining UKCA marking for medical devices. Our specialized team provides comprehensive consulting services to guide you through the complex process, ensuring your medical device meets all necessary requirements and regulations for successful market entry in the United Kingdom.
What is UKCA Marking for Medical Devices?
The UKCA (United Kingdom Conformity Assessment) marking is a logo that signifies a medical device’s compliance with the UK MDR 2002 requirements. This mark confirms that the device is safe, fit for its intended purpose, and complies with the legislation related to safety. It is a mandatory requirement for medical devices intended for the Great Britain market, which includes England, Wales, and Scotland.
Who Needs UKCA Marking for Medical Devices?
If you are involved in the manufacture, distribution, or import of medical devices in the UK, you may be required to obtain UKCA marking. This includes:
- Medical device manufacturers based in the UK.
- Distributors of medical devices in the UK
- Companies importing medical devices into the UK
Key Requirements for Placing Medical Devices in the Great Britain Market:
- New Product Marking (UKCA Mark): Ensure that your medical device carries the UKCA mark.
- Registration with MHRA: All medical devices and IVDs must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) before they can be placed on the market.
- UK Responsible Person: If you are a manufacturer located outside the UK, you must appoint a single UK responsible person.
- Classification: Medical devices in the UK are categorized as Class I, Class IIa, Class IIb, and Class III, similar to the European Union’s classification. Class I devices are low-risk, while Class III devices are high-risk.
MHRA Registration Process for Medical Devices (UKCA Marking Process)
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s regulatory authority responsible for ensuring that medicines and medical devices are safe and effective.
- Classification: Determine the classification of your medical device according to the European Union’s Medical Device Regulation (MDR).
- Conformity Assessment: Conduct a conformity assessment to demonstrate that your device meets safety and performance requirements.
- Technical Documentation: Prepare technical documentation that includes device descriptions, intended use, and clinical data.
- Application Submission: Submit your application to the MHRA through the Medical Devices Information System (MDIS).
- Evaluation: MHRA will evaluate your application and technical documentation to ensure compliance with safety and performance requirements.
- Registration Certificate: If your application is successful, MHRA will issue a registration certificate, allowing you to sell your medical device in the UK.
Also Read: Guide to MHRA medical device registration
Summary to Remember:
- The medical devices to be placed in the UK market need to get registered with MHRA within the grace period. CE mark will be recognized till June 30,2024.
- If you are outside UK, manufacturer needs to appoint UK responsible person (UKRP)
- If the device is CE certified the product can be placed in the UK market by June30,2024. There will be no need to rebel.
- After June 30,2024 It will be mandatory for the manufacturer to have UKCA mark on their medical device product to be placed in UK market, whereas for NI (Northern Ireland) CE marked devices can be placed even after June 30, 2024.
Unlock the UK Market With UKCA Marking for Your Medical Device
How will Operon Strategist Help you Get UKCA Marking for Medical Devices?
Operon Strategist is a leading regulatory consulting firm with expertise in securing UKCA marking for medical devices. Our services include:
Regulatory Guidance: We provide comprehensive guidance on navigating the UKCA marking process, ensuring that you meet all regulatory requirements.
Gap Analysis: Our experts conduct a thorough analysis to identify any gaps in your compliance, helping you rectify them effectively.
Compliance Assistance: We assist in preparing technical documentation, guiding you through the conformity assessment process, and helping with application submission to the MHRA.
Successful Market Entry: Our partnership guarantees that your medical device complies with UKCA marking requirements, facilitating a smooth market entry process.
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.
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FAQ's
For UKCA marked devices, at a minimum, products can be placed on the market until either the relevant certificate expires, or for three years (in the case of general medical devices) or five years (in the case of in vitro diagnostics or IVDs).
The UKCA marking is the product marking used for products being placed on the market in Great Britain (England, Scotland and Wales). The UKCA marking applies to most products for which the CE marking could be used. It also applies to aerosol products that previously required the reversed epsilon marking.
To become an Approved Body you must be appointed by a UK Competent Authority to undertake conformity assessment activities for the purposes of UKCA marking of products to be placed on the GB market.