UK Medical Device Regulation

Regulating medical devices and IVDs in the UK meet the MHRA requirements and UKCA certification.

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Market Access
Medical Device Regulations UK

Regulatory Compliance for the UK Market

Medical Device Regulations 2002

Since January 1, 2021, all medical devices and in vitro diagnostic medical devices (IVDs) sold in the UK must be registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). Manufacturers must comply with the UK Medical Device Regulations 2002 and go through a UKCA Marking process. The UK government is developing a new, more robust medical devices regime, set to take effect from July 1, 2025.

Due to Brexit, there have been changes in the market placement of medical devices in Great Britain. Non-UK manufacturers must designate a UK Responsible Person.

The current UK market route and UKCA marking follow EU-derived requirements. During the transitional period, a valid CE mark allows medical devices to be sold in the UK.

How long can a valid CE mark be sold in the UK?

A valid CE mark will allow medical devices to be sold in the UK market for the following periods:

General medical devices under EU MDD or EU AIMDD can be sold until the earlier of certificate expiry or June 30, 2028.
IVDs under EU IVDD can be sold until the earlier of certificate expiry or June 30, 2030.
General medical devices under EU MDR and IVDs under EU IVDR can be sold until June 30, 2030.

UK market access transition timelines

Understanding the UK regulation changes amid EU transitions is challenging. MHRA has released new guidance and infographics to help. Qserve closely monitors UK market developments and regularly shares information and blogs to support manufacturers.

Read Qserve's blog on the transition timelines and what this means for Medical Devices and In Vitro Diagnostics. There is detailed information on timelines for placing CE-marked IVDs and Medical Devices.

Medical Device Classification in the UK

Risk-based classification

The MHRA classifies medical devices and IVDs in the UK by risk levels:

Class I: Low-risk (e.g., syringes without needles, adhesive bandages)
Class IIa: Lower medium-risk (e.g., short-term corrective contact lenses, hearing aids)
Class IIb: Higher medium-risk (e.g., apnoea monitors, surgical lasers)
Class III: High-risk (e.g., pacemakers, breast implants)

Manufacturers must demonstrate conformity with UK requirements, with the assessment depth varying by device class. They must provide accurate, updated information to the MHRA and be prepared to supply additional technical documents if requested.

In Vitro Diagnostics Classification in the UK

Perceived risk

IVDs are classified by their risk to patient safety:

General IVDs: Marketed with self-declared compliance without third-party assessment.
IVDs for Self-Testing: Designed for home use by non-professionals, excluding some self-test medical devices.
IIVDs in Annex II List B: Includes reagents for diseases like rubella, toxoplasmosis, phenylketonuria, and self-testing blood glucose devices.
IVDs in Annex II List A: Includes reagents for HIV I/II, Hepatitis B/C/D, blood group determinants, and tests for donated blood.

The MHRA is reviewing IVD classification rules to enhance scrutiny in line with rapid advancements in the field.

Medical Device Registration and IVDs

Qserve's Regulatory Affairs experts are ready to help you register your medical devices and IVDs with the MHRA in the UK. We stay up-to-date with current regulations and transitional arrangements to ensure your compliance.

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UKCA certification

For market access in the UK, the correct registration route depends on your product type. Qserve can assist with UKCA certification for new medical devices and IVDs, ensuring a smooth registration process.

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Qserve services for UK

MHRA registration support in the UK
UKCA certification
Compile Technical Documentation
UK Responsible Person (UK RP)
Vigilance Reporting

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Representation for foreign manufacturers

UK Responsible Person

Companies outside the UK must appoint a UK Responsible Person (UK RP) to handle all MHRA communications and registration.

The role of the UK RP:

Registers devices with the MHRA
Verifies conformity with CE or UKCA marking requirements
Reviews the declaration of conformity and technical documentation
Ensures proper conformity assessment procedures
Maintains copies of technical documentation and declarations
Acts as the contact point with the MHRA and notifies new UK importers
Cooperates with the MHRA on corrective actions to mitigate device risks

As a market leader, Qserve is your trusted partner for seamless compliance.

UK Responsible Person

Additional Regulatory Requirements

Save and effective devices

To comply with the UK medical device regulations, manufacturers must fulfill several obligations besides the basic requirements to show that devices are safe and effective. These include: 

Conducting a Clinical Evaluation Study
Implementing a Quality Management System (QMS) that follows the ISO 13485 standard
Setting up a Post-Market Surveillance (PMS) system
Reporting any serious incidents or field safety corrective actions to the MHRA
Applying a Risk Management process that complies with ISO 14971
Label devices properly with the UKCA mark and provide user information

IVDs are subject to specific regulations that may need additional evidence to support their safety and performance.

UK regulatory compliance and medical device registration support

Do you need assistance in understanding the UK Medical Device Regulations and UKCA marking?

Qserve is your trusted partner for UK market access.

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Great Britain, UK, and Northern Ireland

Which regulations apply?

UK Medical Device Regulation countries are England, Scotland and Wales. These Great Britain countries comply with the UK Medical Device Regulations 2002 (as amended) and must be registered with the MHRA.

The UK stands for the United Kingdom of Great Britain and Northern Ireland, which is a sovereign country that includes the entire island of Great Britain and the northern part of the island of Ireland (Northern Ireland).

Northern Ireland, while part of the UK, follows a different set of rules due to the Northern Ireland Protocol. In Northern Ireland, EU medical device regulations apply, which means medical devices must adhere to the EU Medical Device Regulation (MDR) 2017/7452.

Regulatory timelines and fees

Already CE or UKCA marked?

If the device is already CE or UKCA marked, the estimated timeline to enter the market is approximately two weeks. However, if the device is not marked, the process may take an additional 2-4 months for the lowest-risk devices to 1-2 years for mid-to-high-risk devices.

Additionally, CE-marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023 as part of the transitional arrangements towards a future strengthened regulatory framework for medical devices. Core aspects of the future framework are intended to apply from 1 July 2025.

The MHRA charges a fee of £240 for each registration. Every change in the database except additional devices to the same GMDN code is charged with a fee of £240. The MHRA will need five working days to review applications.

Important links and guidance documents

Where to find more information?

It’s important to consult the specific guidance provided by the MHRA and other relevant UK authorities to ensure compliance with the registration process.