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.
December 2, 2024
Approximately 5 minutes
UK Medical Device Regulation: The Role of the MHRA, UKCA Marking, and Transitional Arrangements
UK Medical Device Regulation: Key Requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the medical devices market in the United Kingdom (UK). This guidance primarily focuses on the requirements for placing devices on the Great Britain (GB) market (England, Wales, and Scotland).
1. Legislation and Conformity Marking
The regulation is based on the Medical Devices Regulations 2002 (UK MDR 2002), which originally implemented legacy EU directives (EU MDD, EU AIMDD, EU IVDD).
The UKCA Marking
The UKCA (UK Conformity Assessed) marking is the new product marking for medical devices placed on the Great Britain market, replacing the CE marking for the long term.
- For devices requiring third-party conformity assessment, a UK Approved Body must be used.
- Manufacturers of non-sterile and non-measuring Class I devices and general IVDs can use self-certification for the UKCA mark.
Transitional Acceptance of the CE Marking
The UK government has introduced transitional measures to allow the continued acceptance of CE-marked medical devices on the GB market beyond June 30, 2023. The acceptance period depends on the device's classification and its compliance status:
| Device Type | Compliance Basis | Final Date for Placement on GB Market |
|---|---|---|
| General Medical Devices | EU MDD/AIMDD (with valid certificate) | Sooner of certificate expiry or June 30, 2028 |
| IVDs | EU IVDD (with valid certificate) | Sooner of certificate expiry or June 30, 2030 |
| All Devices (including custom-made) | EU MDR/IVDR compliant | June 30, 2030 |
2. Registration and UK Responsible Person
All medical devices, including IVDs and custom-made devices, must be registered with the MHRA before they are placed on the Great Britain market.
The UK Responsible Person (UKRP)
Manufacturers based outside the UK must appoint a single UK Responsible Person (UKRP) for all their devices. The UKRP acts on the manufacturer's behalf to carry out specified tasks, including:
- Registering the manufacturer's devices with the MHRA.
- Ensuring the Declaration of Conformity and technical documentation have been drawn up.
- Providing documentation to the MHRA upon request.
- Cooperating with the MHRA on any preventive or corrective actions.
The name and address of the UK Responsible Person must be included on the product labeling, outer packaging, or Instructions for Use when the UKCA marking is affixed.
Related Articles
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 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.