UK MHRA Med Dev Guidance: Register medical devices to place on the market and Comprehensive Summary (Jan 2026)

In 2026, several key guidances published on GOV.UK clarify the rules manufacturers, sponsors, and regulators must follow for clinical investigations, market placement, conformity assessment, and exemptions. This blog covers four major guidances released and maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government. Collectively, they form an essential framework for anyone involved in medical device development, clinical evaluation, regulatory compliance, or market authorization in the UK.

1. Guidance: Notify MHRA about a clinical investigation for a medical device

Clinical investigations — evaluations involving human participants — are essential to generate evidence on safety and performance of medical devices, particularly where existing conformity marks do not cover intended use.

Key Requirements and Highlights:

• Who must notify: Sponsors or manufacturers planning a clinical investigation for a device without a valid UKCA/CE mark for the study indication.

• When to notify: Notification to MHRA must be made at least 60 days before the planned start date.

• Why notify: Enables the regulator to oversee participant safety, ensure compliance with UK standards, and coordinate with ethics and governance review.

This guidance ensures transparency and regulatory oversight for clinical evidence generation crucial for subsequent conformity or marketing steps.

2. Guidance: Medical devices: conformity assessment and the UKCA mark

Before a medical device can be sold in Great Britain (England, Scotland, Wales), it must comply with UK medical device regulations and carry the UKCA (UK Conformity Assessed) mark.

Key Elements Explained:

• What UKCA means: A declaration that the device meets applicable regulatory requirements, including safety, quality, and performance standards.

• Routes by device risk:

  • Low-risk devices (Class I): Often self-declaration by the manufacturer.

  • Higher-risk devices: Require an assessment by a UK-approved conformity assessment body.

• Northern Ireland: Devices placed on the NI market may require CE or CE UKNI marking under separate arrangements.

This guidance is critical for regulatory strategy, conformity route planning, and avoiding market placement delays.

3. Guidance: Register medical devices to place on the market

Even when conformity assessment is complete, manufacturers must still register their devices with MHRA before placing them on the UK market.

What You Must Know:

• Who registers: Manufacturers, or UK Responsible Persons for non-UK manufacturers.

• When: Must be completed before market placement.

• What’s required: Manufacturer details, device classification, intended use, and technical documentation.

Registration is a pre-market administrative requirement and does not replace conformity assessment or imply approval of safety/performance.

4. Guidance: Health Institution Exemption for general medical devices

This guidance explains conditions under which healthcare institutions (such as NHS trusts, hospitals, clinics) can manufacture or modify medical devices for internal use without undergoing full conformity assessment or registration.

Key Takeaways:

• Who qualifies: Health institutions primarily engaged in patient care.

• Conditions required:

  • The device is manufactured solely for use within that institution.

  • No transfer to another legal entity or wider market distribution.

• Benefits: Enables tailored innovation for clinical needs while maintaining regulatory control and patient safety.

This exemption supports innovation in clinical settings while ensuring appropriate oversight.

These guidances form a foundational framework for regulated parties:

• Clinical evidence generation (clinical investigations)

• Conformity and market access (UKCA marking)

• Administrative registration duties (device listing with MHRA)

• Exemptions for clinical innovation (health institution provisions)

Staying up to date with these documents helps manufacturers, sponsors, and regulatory teams ensure compliance, minimize delays, and protect patient interests.

For more detailed regulatory requirements and step-by-step procedural guidance, kindly refer to the official documents via the above linked guidance links.