Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
February 2, 2025
Approximately 5 minutes
UK Medical Device and IVD Registration: The UKCA Transition and UK Responsible Person Requirements
Medical Device and IVD Registration in Great Britain (GB)
[cite_start]The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory body responsible for medical devices and In Vitro Diagnostic (IVD) devices in the UK, particularly within Great Britain (England, Wales, and Scotland)[cite: 1, 23].
Key Market Requirements for Great Britain
[cite_start]All medical devices, including IVDs, custom-made devices, and systems or procedure packs, must be registered with the MHRA before being placed on the GB market[cite: 121].
1. The UK Responsible Person (UKRP)
[cite_start]Manufacturers based outside the UK are considered "third country" manufacturers and must appoint a UK Responsible Person (UKRP)[cite: 105, 106].
- [cite_start]Role: The UKRP acts on the manufacturer's behalf, with a role similar to the Authorized Representative in the EU[cite: 111, 113].
- [cite_start]Registration Duty: The UKRP must register the manufacturer, the importer, and all applicable devices with the MHRA[cite: 123].
- [cite_start]Importer Requirement: Devices from non-UK manufacturers must also be placed on the market by a UK-established importer[cite: 106, 107].
2. Conformity Marking and Transition
[cite_start]The new mandatory conformity mark for the GB market is the UK Conformity Assessed (UKCA) marking[cite: 142].
- [cite_start]CE Mark Acceptance: The GB market will remain open for CE-marked medical devices and IVDs until, at the latest, June 30, 2030, depending on the device type and classification[cite: 86, 140].
- [cite_start]Labelling: The name and address of the UKRP must be indicated on the product label, outer packaging, or instructions for use, but only in cases where the UKCA marking has been affixed (including dual-marked devices)[cite: 146].
3. MHRA Registration Process
[cite_start]Registration with the MHRA is necessary for market surveillance[cite: 120].
- [cite_start]Process: The UKRP is required to complete the registration process on behalf of the non-UK manufacturer[cite: 122, 125].
- [cite_start]Classification: Devices are registered as a device family based on the Global Medical Device Nomenclature (GMDN) code, not the EMDN code used for EUDAMED[cite: 127, 128].
- [cite_start]Fee: A fee of £240 applies for each application, which can cover up to 100 devices with a cumulative maximum of 20,000 products[cite: 129, 130].
Note: This guidance primarily relates to the Great Britain market. [cite_start]Northern Ireland has a special status, with CE marking remaining applicable due to the Northern Ireland Protocol[cite: 159, 167].
Related Articles
Approximately 5 minutes
UK Medical Device Regulation: The Role of the MHRA, UKCA Marking, and Transitional Arrangements
The **MHRA** regulates medical devices in Great Britain (GB), requiring mandatory registration. The new **UKCA marking** is the post-Brexit route to market, replacing the CE mark. However, due to transitional arrangements, CE-marked devices can continue to be placed on the GB market until dates ranging from **June 2028 to June 2030**, depending on the device class and compliance with EU directives/regulations.
Approximately 5 minutes
UK Medical Device Registration (MHRA): Compliance, UKCA Marking, and the UK Responsible Person
To sell medical devices in Great Britain, manufacturers must comply with the **UK MDR**, obtain the **UKCA Marking**, and mandatorily register their devices with the **MHRA**. Foreign manufacturers must appoint a **UK Responsible Person (UKRP)** to handle registration and post-market responsibilities on their behalf.
Approximately 5 minutes
UK Medical Device Registration Process: A 6-Step Guide to MHRA Compliance
Registering a medical device for the UK market involves mandatory compliance with the **MHRA**. This guide outlines the 6 essential steps, from device classification and conformity assessment to appointing a **UK Responsible Person (UKRP)** and final submission via the **DORS** system.
Approximately 5 minutes
The Regulatory Trilemma: Navigating MDR, AI Act, and GDPR for Medical AI in the EU
Medical AI in the EU faces a "regulatory trilemma" where the **MDR's static framework** conflicts with the **AI Act's dynamic requirements** for continuously learning models. This, coupled with **GDPR data constraints**, slows innovation by forcing AI's self-improvement cycle to stop for repeated evaluation.