UKCA Marking for Medical Devices
What is UKCA Marking?
UKCA (UK Conformity Assessed) marking is the product certification required for medical devices sold in Great Britain, introduced as a replacement for the CE mark following the UK’s departure from the European Union. It confirms that a medical device meets the applicable requirements under the UK Medical Device Regulations (UK MDR 2002) and has passed the appropriate conformity assessment procedures. The UKCA mark signifies compliance with safety, quality, and performance standards specific to the UK market.
UKCA Marking for Medical Devices
Following Brexit, the UK Conformity Assessed (UKCA) marking has become a mandatory certification for medical devices placed on the Great Britain market, which includes England, Scotland, and Wales. The UKCA marking replaces the CE mark for these regions and confirms that a product complies with the UK Medical Device Regulations (UK MDR 2002).
Medical device manufacturers outside the United Kingdom must obtain UKCA marking to ensure regulatory compliance and lawful market entry. The marking signifies that a medical device meets applicable safety and performance standards required by UK authorities.
UKCA Marking Process for Medical Devices in the UK
UKCA marking is required to demonstrate that a medical device meets the UK MDR 2002 standards and can be legally placed on the Great Britain market. Manufacturers must conduct a conformity assessment appropriate to the risk classification of the device.Once conformity is established, the UKCA mark must be applied to the device and its packaging. This certification process confirms compliance with essential requirements for product safety, performance, and labelling as set by UK regulations.For the Northern Ireland market, CE marking or UKNI marking is still required. UKCA marking alone is not valid for Northern Ireland placement.
Exemptions from UKCA Marking
Certain medical devices may be exempt from the UKCA marking requirement, provided they meet conditions set out in UK MDR 2002. These include:
- Devices used exclusively for clinical investigation
- In-vitro diagnostic (IVD) devices intended for performance evaluation
- Non-compliant devices used in exceptional humanitarian situations
- Custom-made devices that meet the applicable requirements
These exemptions are consistent with earlier European legislation, including the EU Directives for medical devices, active implantables, and IVDs.
What is MHRA?
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the United Kingdom’s national authority responsible for regulating medical devices and other healthcare-related products. Under the UK Medical Device Regulations (UK MDR 2002), the MHRA ensures that medical devices placed on the UK market are safe, effective, and comply with applicable regulatory requirements. All manufacturers intending to sell medical devices in Great Britain must interact with MHRA for product registration, post-market surveillance, and conformity assessments where applicable.
MHRA Registration Process
Manufacturers must submit specific details to the MHRA for registering their medical devices:
- Legal entity name and address
- Company type
- Administrative contact information
- Classification of the device
- Device name
- UDI-DI (if applicable)
Accurate registration with the MHRA is an essential prerequisite before a device can be marketed in Great Britain.
The Role of MHRA in UK Medical Device Regulation
The Medicines and Healthcare Products Regulatory Agency (MHRA) serves as the regulatory body responsible for the oversight of medical devices in the UK. To sell a medical device in Great Britain, manufacturers must comply with the MHRA’s requirements and complete the UKCA marking process.
Key compliance requirements include:
- UKCA Marking Requirement: Effective from January 1, 2023, UKCA marking is mandatory for medical devices entering the Great Britain market. CE marking will remain acceptable only until June 30, 2024.
- Appointment of UK Responsible Person (UKRP): Manufacturers based outside the UK must appoint a UKRP. This individual or entity serves as the legal representative in the UK, responsible for MHRA communication and device registration.
- Classifications of Medical Devices: The UK follows a classification system similar to that of the European Union, with devices categorized as Class I, Class IIa, Class IIb, and Class III. Higher-risk devices require more rigorous assessment and involvement of UK Approved Bodies for UKCA marking.
Key Dates and Transitional Periods
Manufacturers must be aware of the following deadlines:
- CE Mark Validity: Medical devices with valid CE marking may continue to be placed on the UK market until June 30, 2024.
- UKCA Marking Deadline: After June 30, 2024, UKCA marking will be mandatory for all medical devices marketed in Great Britain.
- Northern Ireland Regulations: CE or UKNI marking remains applicable in Northern Ireland even after the transition period ends.
These transitional provisions allow manufacturers time to adjust their compliance strategies before the full enforcement of UKCA marking.
Why Choose Operon Strategist for UKCA Marking?
Operon Strategist is a trusted regulatory consulting partner for medical device manufacturers seeking market access in the UK. With over 12 years of industry experience, we offer a structured and reliable pathway to UKCA certification.
Our services include:
- Technical Documentation Preparation: We develop and maintain complete technical files in alignment with MHRA and UK MDR requirements.
- Conformity Assessment Support: Our team provides assistance in selecting and completing the appropriate conformity assessment procedure based on the classification of your device.
- Quality Management System (QMS) Implementation: We support the implementation of QMS based on ISO 13485 standards to meet UK regulatory expectations.
- Regulatory Submissions: Operon Strategist manages device registration with MHRA, oversees submission processes, and responds to regulatory queries.
- UK Responsible Person (UKRP) Services: We act as your UKRP, handling local representation and all required communication with UK authorities.
Our approach ensures reduced risk of delays, faster market entry, and full alignment with MHRA expectations.
FAQ'S
UKCA (UK Conformity Assessed) is the conformity marking required for many products being placed on the market in Great Britain. It came into effect on 1 January 2021, replacing or complementing CE marking for many product categories.
Most goods that previously required CE marking now require UKCA marking for the GB market. This includes products like electrical equipment, machinery, PPE, and many others. Some product sectors have specific rules such as medical devices, marine equipment, and construction products.
Yes. CE-marked products are still recognized in Great Britain for a transitional period, but UKCA marking will eventually become the mandatory requirement for most product categories.
It depends on the product category and associated risk. For many lower-risk products, manufacturers can self-declare conformity. Higher-risk or regulated products typically require assessment by a UK Approved Body.
You’ll need documentation including a Declaration of Conformity, technical files showing how the product complies with essential UK requirements, information about design and manufacture, test or assessment results, labelling details, and any conformity assessment reports.