UKCA Marking Consultant in the USA
Looking to launch your medical device in the UK market? You’ll need UKCA marking—your proof of compliance with UK regulatory standards. Operon Strategist provides complete UKCA marking consultancy services for medical devices and IVDs, helping manufacturers navigate MHRA requirements, appoint a UK Responsible Person (UKRP), and manage technical documentation.
What is UKCA marking for medical devices?
After Brexit, the UK introduced the UK Conformity Assessment (UKCA) mark as a replacement for the CE mark in Great Britain (England, Wales, Scotland). Governed by the MHRA (Medicines and Healthcare Products Regulatory Agency), UKCA marking ensures that medical devices and IVDs meet all relevant UK laws and standards.
What are the Requirements for UKCA Marking for Medical Devices & IVDs?
1. General Compliance Requirements
- Adhere to UK regulations derived from former EU directives (MDD, AIMDD, IVDD).
- Prepare comprehensive technical documentation aligned with UK MDR 2002.
- Replace EU legal references with relevant UK legislation.
- Demonstrate conformity through appropriate assessment procedures.
2. UK Responsible Person (UKRP) Requirement
- Non-UK manufacturers must appoint a UKRP who acts on their behalf for all MHRA communications and compliance matters.
- The UKRP’s name and address must be included on product labeling.
3. MHRA Device Registration
- All medical devices and IVDs must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
- The transition period ended on January 1, 2022, so registration is now mandatory before marketing in the UK.
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.
How do Operon Strategist Experts Help with the UKCA Marking Process?
We simplify the entire UKCA compliance process, ensuring your medical device is ready for the UK market without delays or missteps.
Our Services Include:
- UKCA Strategy Consultation – personalized regulatory roadmap based on your device type and current CE status.
- Technical Documentation Support – gap assessment, preparation, and alignment with UK MDR.
- Conformity Assessment Assistance – preparation for audits and MHRA requirements.
- UKRP Appointment Support – connect with trusted UK Responsible Persons.
- MHRA Device Registration – complete support for regulatory filing.
- Regulatory Intelligence & Updates – stay ahead with ongoing UKCA and MHRA changes.
Why Choose Operon Strategist?
With deep expertise in global medical device regulations, we’ve helped manufacturers from the USA, EU, Middle East, and Asia enter the UK market seamlessly.
📞 Ready to get UKCA certified?
Let our experts guide your regulatory journey.
Contact us now to book a consultation.
FAQs
What is the difference between UKCA and CE marking for medical devices?
UKCA (UK Conformity Assessed) marking applies to products placed on the market in Great Britain, while CE marking is used within the EU. After Brexit, UKCA became mandatory for GB, and medical devices must comply with UK MDR 2002, not the EU MDR/IVDR.
Can one product have both CE and UKCA markings?
Yes, a device can carry both CE and UKCA markings if it meets the respective requirements for each market. However, you must maintain separate technical documentation and compliance processes for each.