Understanding UKCA Marking & UK Regulatory Process
What is UKCA Marking for Medical Devices?
Following Brexit, the UK Conformity Assessed (UKCA) marking has replaced the EU CE Mark as the required certification for medical devices entering the Great Britain (England, Scotland, and Wales) market. For manufacturers outside the UK, obtaining UKCA marking ensures that your product complies with the UK Medical Device Regulations (UK MDR 2002), enabling its placement in the UK market. The UKCA marking is crucial for demonstrating that your medical device meets UK safety standards.
The Role of MHRA in UK Medical Device Regulation
The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees medical device regulations in the UK. To market your medical device in the UK, manufacturers need to comply with MHRA registration and the UKCA marking process. Below are key steps for compliance:
- UKCA Marking Requirement: From January 1, 2023, the UKCA marking is mandatory for devices intended for Great Britain. The CE marking will remain valid until June 30, 2024.
- Appointment of UK Responsible Person (UKRP): If you are based outside the UK, you must appoint a UKRP who acts as your legal representative in the UK to handle registrations and communications with MHRA.
- Classifications of Medical Devices: The UK classifies medical devices similarly to the EU. Devices are categorized into Class I, Class IIa, Class IIb, and Class III, based on risk. Higher-risk devices require more stringent regulations and third-party assessments for UKCA marking.
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MHRA Registration Process
- Legal entity name and address
- Company Type
- Administrative Contact
- Class of the device
- UDI-DI if applicable
- Medical device name
UKCA Marking Process for Medical Devices in the UK
To get placed in the UK market medical devices need to have UKCA marking means UK product marking. UKCA stands for UK Conformity Assessed, UKCA marking is a substitute for the EU requirement of CE marking. For the Northern Ireland market CE mark or UKNI mark is required for the placement of medical devices in Northern Ireland market.
You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route depends on the classification of the device. A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002.
Exemptions: One should not put UKCA mark on product if,
- The product is exclusively for clinical investigation and meets the requirement as far as possible.
- an in vitro diagnostic medical device (IVD) for performance evaluation
- a non-compliant device used in exceptional circumstances (humanitarian grounds)
- Custom made device which meet the requirement in UKMDR 2002
The UKCA marking requirement is based on EU legislation such as for active implantable devices EUAIMDD, for medical devices (EUMDD) In vitro diagnostic medical devices (EUIVDD).
Exemptions from UKCA Marking
Not all medical devices require the UKCA marking. Exemptions include:
- Devices used exclusively for clinical investigation.
- In-vitro diagnostic (IVD) medical devices for performance evaluation.
- Devices used in exceptional humanitarian circumstances.
- Custom-made devices that meet specific requirements under UK MDR 2002.
Key Dates and Transitional Periods
- CE Mark Validity: CE marked devices can be placed on the UK market until June 30, 2024.
- UKCA Marking Deadline: After June 30, 2024, all medical devices must have the UKCA mark to be sold in Great Britain.
- Northern Ireland: For the Northern Ireland market, CE marking or the UKNI mark will be required, even after June 30, 2024.
Why Choose Operon Strategist for UKCA Marking?
At Operon Strategist, we specialize in UKCA marking and medical device regulatory compliance. With over 12 years of experience, our expert consultants provide:
- Technical Documentation: We prepare all necessary documents to meet MHRA and UKCA marking requirements.
- Conformity Assessment Support: We assist with the conformity assessment process, ensuring that your medical device is compliant with UK MDR 2002.
- Quality Management System (QMS): We help implement QMS to meet UK regulatory standards.
- Regulatory Submissions: We manage the submission process to the MHRA, respond to inquiries, and handle any follow-up actions until approval.
- Expert Guidance: Our team ensures that you navigate the complex UK medical device regulations efficiently, saving you time and effort.
Contact Operon Strategist for UKCA Marking Assistance
Are you ready to place your medical device in the UK market? Operon Strategist offers expert support for the UKCA marking process. Whether you need guidance on MHRA registration, UK Responsible Person (UKRP) designation, or technical documentation, we’re here to help.