UK Medical Device Regulation

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

Regulatory Compliance for the UK Market

Medical Device Regulations UK

Since 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). Manufacturers need to follow the UK Medical Device Regulations 2002 rules. The UK government is developing a more robust future medical devices regime, with key aspects expected to apply from 1 July 2025.

Due to Brexit, there have been a number of changes to how medical devices are placed on the market in Great Britain. Medical device manufacturers outside the UK will have to designate a UK Responsible Person Market Access/Medical Device Regulations UK.jpg?preset=content

The current UK route to market and UKCA marking follow the requirements derived from the EU legislation. A valid CE mark will allow the medical device during the transitional arrangements timeline to be sold in the UK market. 

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

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

  • General medical devices that comply with the EU MDD or EU AIMDD and have a valid declaration and CE marking can be sold in Great Britain until the earlier of certificate expiry or 30 June 2028.
  • IVDs that comply with the EU IVDD can be sold in Great Britain until the earlier of certificate expiry or 30 June 2030.
  • General medical devices, including custom-made devices, that comply with the EU MDR and IVDs that comply with the EU IVDR can be sold in Great Britain until 30 June 2030.

UK market access transition timelines

Understanding the changes to the UK Regulations in the context of the EU transitions is an ongoing challenge. MHRA has issued new guidance, including handy infographics to help wrap your head around this tricky subject. Qserve closely follows the changes and developments in the UK market and regularly writes blogs and shares information to inform manufacturers and support them in the next steps.

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 is responsible for classifying medical devices and IVDs in the UK according to their risk levels. Medical devices are divided into four classes based on their risk:

  • Class I: Low-risk devices, such as syringes without needles and standard adhesive bandages.
  • Class IIa: Lower medium-risk devices, such as short-term corrective contact lenses and standard hearing aids.
  • Class IIb: Higher medium-risk devices, such as apnoea monitors and surgical lasers.
  • Class III: High-risk devices, such as pacemakers and breast implants.

Manufacturers must show that their device meets the UK requirements through a conformity assessment, which varies in depth depending on the device’s class. Manufacturers need to provide accurate and updated information to the MHRA and be ready to show more technical documents if requested.

In Vitro Diagnostics Classification in the UK

Perceived risk

The following categories classify IVDs according to the potential risk they pose to patient safety:

  • General IVDs: These devices, not fitting into other categories, can be marketed by self-declaring compliance without third-party assessment.
  • IVDs for Self-Testing: These devices, except for certain self-test medical ones, are designed for home use by laypersons.
  • IVDs in Annex II List B: This category includes reagents and products for diseases like rubella, toxoplasmosis, and phenylketonuria, along with medical devices for self-testing blood glucose levels.
  • IVDs in Annex II List A: This covers reagents and products for HIV I and II, Hepatitis B, C, and D, blood group determinants like ABO systems and anti-kell, including tests for donated blood and screening.

The MHRA is reviewing the IVD classification rules to increase the level of scrutiny applied to IVD devices, reflecting the rapid developments and innovation in the field of IVDs.

Medical Device Registration and IVDs

Qserve's Regulatory Affairs experts can help you register your medical devices and in vitro diagnostic medical devices (IVDs) with the MHRA in the UK. Qserve understands the current regulations and transitional arrangements. 

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UKCA certification

The correct registration route for market access in the UK depends on the product type you want to register. For new medical devices, including In Vitro Diagnostic devices (IVDs), Qserve can help you with UKCA certification. 

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Representation for foreign manufacturers

UK Responsible Person

Companies without an establishment in the UK must appoint a UK Responsible Person (UK RP). The UK Responsible Person acts on behalf of the foreign manufacturer for all communications with the MHRA, including the registration.

The role of the UK RP:
  • Device registration with the MHRA
  • Conformity verification (appropriate CE or UKCA mark)
  • Set up a declaration of conformity and draw up technical documentation
  • Appropriate assessment procedure by the manufacturer
  • Keep available a copy of technical documentation and the declaration of conformity
  • Point of contact between the manufacturer and the MHRA, notify new UK importers
  • Cooperating with the MHRA on corrective actions to eliminate or reduce risks posed by the device.

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 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.