How to Register Medical Devices in the UK: A Comprehensive Guide for UK and International Manufacturers
Registering medical devices in the UK is essential for manufacturers aiming to market their products in Great Britain (England, Scotland, and Wales). Whether you are a UK-based manufacturer or an international entity from regions like the EU, Turkey, USA, or Canada, understanding the registration process with the Medicines and Healthcare products Regulatory Agency (MHRA) is crucial.
This guide provides detailed insights into the MHRA medical device registration process, associated fees, the impact of the UK's evolving regulatory landscape—including the extended recognition of the CE mark and the transition to the UK Conformity Assessed (UKCA) mark—and the latest updates on Post-Market Surveillance (PMS) requirements and future UK MDR regulations.
What is MHRA Registration?
MHRA registration involves officially listing medical devices, in vitro diagnostics (IVDs), and active implantable medical devices with the UK's regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA). This process ensures that all devices marketed in the UK meet the necessary safety, quality, and performance standards.
Why is MHRA Registration Important?
MHRA registration ensures compliance with the UK Medical Devices Regulations 2002 (as amended). Manufacturers, importers, and distributors must register their devices to:
Demonstrate conformity with applicable safety and performance standards.
Legally market their devices in Great Britain.
Avoid enforcement actions, fines, or recalls for non-compliance.
Who Needs to Register Devices with the MHRA?
1. UK-Based Manufacturers
Manufacturers based in the UK are required to register their devices directly with the MHRA.
2. EU-Based Manufacturers
EU manufacturers can currently place CE-marked devices on the UK market until June 30, 2028 (or June 30, 2030 for devices under MDR/IVDR). They must appoint a UK Responsible Person (UKRP) to act on their behalf in the UK. Transitioning to the UKCA mark will eventually require assessments by a UK-approved body.
3. Turkish Manufacturers
Turkey, through its alignment with EU MDR under the EU-Turkey Customs Union Agreement, allows Turkish manufacturers to follow similar processes for CE-marked devices. However, these devices require registration in the UK with a UKRP and must eventually transition to UKCA compliance for continued market access after the CE recognition period.
4. USA-Based Manufacturers
US manufacturers must comply with UK MDR, even if their devices are already FDA-compliant. They are required to appoint a UKRP to handle registrations, ensure UK-specific labeling, and transition to the UKCA mark by the respective deadlines.
5. Canadian Manufacturers
Canadian manufacturers must comply with UK MDR when marketing devices in Great Britain. Similar to US manufacturers, they need to appoint a UKRP and transition to UKCA marking for long-term compliance. Canadian Medical Device Licenses (MDLs) issued under Health Canada’s regulations are not recognized in the UK.
Key Changes Post-Brexit
The UK's departure from the EU has led to several regulatory changes:
The CE mark continues to be recognized in Great Britain until June 30, 2028, for general medical devices compliant with the EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD), and until June 30, 2030, for devices compliant with the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). This extension provides additional time for manufacturers to transition to the UKCA mark.
After these dates, all devices marketed in Great Britain must bear the UK Conformity Assessed (UKCA) mark, with limited exceptions.
Northern Ireland continues to recognize the CE mark under the Northern Ireland Protocol, while devices assessed by UK Notified Bodies must include the UKNI mark alongside the CE mark.
Leveraging the CE Mark
Manufacturers using the CE mark are complying with EU MDR or IVDR standards, not UK-specific regulations. While this is currently accepted for placing devices on the UK market, manufacturers should plan for the transition to the UKCA mark by the respective deadlines.
Applying the UKCA Mark
The UKCA mark signifies compliance with the UK MDR 2002. Manufacturers applying the UKCA mark must:
Obtain conformity assessment certification from a UK-approved body for higher-risk devices.
Update device labeling to include the UKCA logo.
Demonstrate full compliance with UK-specific regulations, which are distinct from EU MDR/IVDR requirements.
Step-by-Step Guide to MHRA Medical Device Registration
Step 1: Classify Your Device
Devices are classified based on risk level:
Class I: Low risk (e.g., bandages, non-invasive devices).
Class IIa: Medium risk (e.g., surgical gloves, infusion pumps).
Class IIb: Higher risk (e.g., ventilators, imaging systems).
Class III: High risk (e.g., pacemakers, implantable devices).
IVDs: Categorized into general IVDs, self-test IVDs, and high-risk IVDs.
For Class I devices and general IVDs, manufacturers can self-certify. Higher classifications require an assessment by a UK-approved body.
Step 2: Appoint a UK Responsible Person (For Non-UK Manufacturers)
Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to manage MHRA registration. The UKRP’s responsibilities include:
Submitting device registrations on behalf of the manufacturer.
Acting as the point of contact with the MHRA.
Retaining technical documentation for the device.
Step 3: Register Using the MHRA Online System
The MHRA uses an online registration system for device registrations. To register:
Create an Account: Manufacturers or UKRPs must set up an account on the MHRA portal.
Submit Device Information: This includes:
Device name, classification, and description.
Manufacturer and UKRP details.
Declaration of Conformity or UKCA certification.
Provide Supporting Documentation: Required documents include labeling, instructions for use (IFU), and conformity certificates.
Step 4: Pay the Registration Fee
The MHRA charges a £240 fee per GMDN code. A GMDN code (Global Medical Device Nomenclature) is a unique identifier assigned to each device category. If multiple devices fall under the same GMDN code, a single registration fee of £240 applies. However, devices with different GMDN codes will require separate registrations and additional fees.
Step 5: Await Confirmation
Once the registration and payment are submitted, the MHRA will review the application. Most registrations are processed within 10 business days. Manufacturers receive an email confirmation upon successful registration.
New Post-Market Surveillance (PMS) Legislation under UK MDR
In 2024, the UK introduced new legislation to strengthen Post-Market Surveillance (PMS) requirements for medical devices. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 aim to enhance patient safety by mandating clearer and more robust PMS practices.
Key Aspects of the New PMS Legislation
Enhanced PMS Systems: Manufacturers are now required to maintain a PMS system proportionate to the risk posed by the device and appropriate to its type. This system must include data collection and analysis relevant to device quality, performance, and safety.
Reporting Requirements: Any significant safety concerns or performance issues identified during PMS activities must be promptly reported to the MHRA.
Future of UK MDR Regulations
The UK government is committed to overhauling the UK Medical Devices Regulations 2002 to align with global best practices while addressing unique national priorities. Key upcoming changes include:
New Conformity Assessment Pathways: Introducing streamlined processes to reduce administrative burdens while ensuring robust safety assessments.
Greater Emphasis on Innovation: Supporting the development of cutting-edge medical technologies.
Enhanced Patient Safety Measures: Strengthening adverse event reporting systems and market surveillance requirements.
These updates are designed to position the UK as a leader in medical device innovation while ensuring compliance with rigorous safety standards.
Conclusion
MHRA registration is a critical step for manufacturers entering the UK medical device market. The extended recognition of the CE mark until 2028 or 2030 (depending on the device) provides additional flexibility for manufacturers transitioning to the UKCA mark.
By understanding the registration process, complying with new PMS requirements, and planning for UK MDR updates, manufacturers can confidently market their devices in the UK. Whether you are based in the UK, EU, Turkey, USA, or Canada, leveraging these guidelines will ensure seamless market access and compliance with UK regulations.