UK Med. Dev Guidance: UKCA Marking, MHRA Regulatory Advice, and the Future Medical Device & IVD Regime

Placing a medical device or in vitro diagnostic (IVD) on the UK market involves more than product design and manufacturing. Manufacturers must demonstrate regulatory compliance, engage effectively with regulators, and prepare for evolving post-market expectations. To support this, the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a series of guidances and roadmaps that explain both current requirements and the future direction of medical device regulation.

This blog brings together four key resources:

• Medical devices: conformity assessment and the UKCA mark

• Medical devices: get regulatory advice from the MHRA

• Implementation of the future regulation of medical devices

• In Vitro Diagnostic roadmap

The MedTech Regulatory Roadmap

The MedTech Regulatory Roadmap provides a timeline view of upcoming regulatory changes, helping manufacturers plan product development, compliance updates, and internal resources in advance.

In Vitro Diagnostic (IVD) Roadmap

IVDs present distinct challenges due to their role in diagnosis, screening, and treatment decisions. The guidance In Vitro Diagnostic roadmap outlines how the UK plans to support the development and regulation of safe IVDs.

Purpose of the IVD Roadmap

The roadmap explains:

• planned regulatory milestones,

• transitional arrangements, and

• how MHRA will engage with industry and healthcare stakeholders.

It provides clarity for manufacturers developing new IVDs or transitioning existing products to future requirements.

Focus on Safety and Innovation

The roadmap balances patient safety with innovation by:

• clarifying regulatory expectations early,

• supporting stakeholder engagement, and

• setting realistic timelines for compliance.

This approach helps ensure that diagnostic innovation continues while maintaining confidence in test reliability and performance.

Conformity Assessment and the UKCA Mark

The guidance Medical devices: conformity assessment and the UKCA mark explains how manufacturers demonstrate that a medical device complies with UK legal requirements before it is placed on the market.

What Is Conformity Assessment?

Conformity assessment is the process used to show that a medical device meets the applicable safety and performance requirements set out in UK law. The level of assessment required depends on the risk classification of the device. Lower-risk devices may be self-certified by the manufacturer, while higher-risk devices require assessment by an Approved Body.

What Is the UKCA Mark?

The UK Conformity Assessed (UKCA) mark is the marking that shows a device conforms with UK regulatory requirements. For most medical devices placed on the Great Britain market, the UKCA mark is required once applicable transitional arrangements end.

The guidance explains:

• when the UKCA mark is required,

• which devices must involve an Approved Body, and

• how technical documentation and declarations of conformity support the marking.

Applying the UKCA mark is not just a label—it represents a formal declaration of compliance with UK law.

Getting Regulatory Advice from the MHRA

Regulatory requirements can be complex, especially for innovative devices or borderline products. The guidance Medical devices: get regulatory advice from the MHRA explains how manufacturers can request regulatory advice meetings.

What Is MHRA Regulatory Advice?

MHRA regulatory advice allows manufacturers to ask questions directly to the regulator about:

• device classification,

• applicable regulatory pathways,

• conformity assessment routes,

• clinical evidence expectations, and

• post-market obligations.

This service helps manufacturers make informed decisions early and avoid costly regulatory mistakes.

How the Advice Process Works

The guidance explains how to:

• submit a request for advice,

• clearly define the questions to be addressed, and

• provide background information to support the discussion.

MHRA advice is non-binding, but it reflects the regulator’s current interpretation of the regulations and is a valuable planning tool—particularly for novel or complex devices.

Implementation of the Future Medical Devices Regulatory Regime

The UK government has published Implementation of the future regulation of medical devices to explain how the UK will modernise medical device regulation.

Why a Future Regime Is Needed

The future regime aims to:

• strengthen post-market surveillance,

• improve traceability and reporting,

• enhance patient safety, and

• create a more responsive regulatory system.

The roadmap document sets out phased implementation, allowing manufacturers time to adapt.

Post-Market Surveillance Changes

A key feature of the future regime is enhanced post-market surveillance (PMS). Manufacturers will be expected to:

• collect and analyse real-world device performance data,

• report serious incidents more systematically, and

• take timely corrective action when safety issues arise.

These changes shift regulatory focus from pre-market approval alone to continuous lifecycle oversight.

These guidances and roadmaps help manufacturers navigate today’s requirements while planning confidently for tomorrow’s regulatory landscape. For full and authoritative details, readers should consult the official guidance documents linked above.