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.
January 2, 2025
Approximately 5 minutes
UK Medical Device Registration (MHRA): Compliance, UKCA Marking, and the UK Responsible Person
UK Medical Device Registration and the UKCA Regime
The market for medical devices in the United Kingdom (specifically Great Britain—England, Wales, and Scotland) is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The core regulatory framework is the UK Medical Devices Regulations (UK MDR).
1. Regulatory Authority and Registration
- Regulator: The MHRA is the primary authority responsible for regulating medical devices in the UK.
- Mandatory Registration: All medical devices, including In Vitro Diagnostic (IVD) devices, must be registered with the MHRA before they can be placed on the Great Britain market.
- Classification: Devices are classified according to their risk level, which determines the necessary regulatory requirements for achieving the UKCA marking and MHRA registration. Higher-risk devices require more rigorous scrutiny.
2. The UK Responsible Person (UKRP)
For manufacturers established outside the UK, market entry requires the mandatory appointment of a UK Responsible Person (UKRP).
- Role of the UKRP: The UKRP acts as the manufacturer’s representative to the MHRA, ensuring ongoing compliance with the UK MDR.
- Responsibilities: The UKRP is responsible for key regulatory tasks, including:
- Registering the manufacturer's devices with the MHRA.
- Ensuring the manufacturer has complied with the UK MDR and affixed the appropriate conformity marking (UKCA).
- Managing communication with the MHRA, including post-market surveillance and vigilance requirements.
3. Conformity and Marking (UKCA)
The UK Conformity Assessed (UKCA) marking is the mandatory conformity mark for medical devices in Great Britain.
- Requirement: Manufacturers must ensure their devices comply with the UK MDR requirements and affix the UKCA mark.
- Transition from CE: Manufacturers must adhere to specific deadlines for transitioning from the EU's CE marking to the UKCA marking. However, the government has introduced transitional arrangements allowing CE-marked devices to continue being placed on the GB market for defined periods (with deadlines extending up to June 30, 2030, depending on device class and compliance).
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 and IVD Registration: The UKCA Transition and UK Responsible Person Requirements
To place devices on the Great Britain market, manufacturers must comply with the UK MDR and register with the MHRA. Foreign manufacturers must appoint a UK Responsible Person (UKRP) and use a UK importer. While the UKCA marking is the new standard, CE-marked devices remain acceptable until up to June 30, 2030, depending on the device's classification.
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.