UK MHRA Med Dev Guidance: Registeration and Clinical investigations for medical devices

The UK regulatory framework for medical devices continues to evolve with a strong focus on market transparency, safety, and clinical evidence generation. Recent updates from the Medicines and Healthcare products Regulatory Agency (MHRA) reinforce the importance of proper device registration and clinical investigation oversight to ensure patient safety and regulatory compliance.

The guidance Register medical devices to place on the market was updated on 10 April 2026, including changes to DORS attributes and administrative fee updates. In parallel, the guidance Clinical investigations for medical devices was updated on 9 April 2026 to correct technical references and improve clarity.

These guidelines apply to all manufacturers, authorised representatives, and stakeholders involved in placing medical devices on the UK market or conducting clinical investigations.

This includes all device types such as general medical devices, in vitro diagnostic devices, custom-made devices, and procedure packs. The requirements apply across Great Britain, with additional considerations for Northern Ireland under EU-aligned regulations.

Guidance: Register medical devices to place on the market 

Manufacturers must register their medical devices with the MHRA before placing them on the Great Britain market, and failure to do so means the device cannot be legally marketed. Registration is completed through the Device Online Registration System (DORS), where applicants must create an account and submit detailed information about the device and organisation.

Registration requires submission of accurate and up-to-date information, including device details, manufacturer information, and evidence of conformity such as CE or UKCA marking. The MHRA may request additional technical documentation to verify compliance before confirming registration.

It is important to note that registration does not constitute approval, certification, or endorsement by the MHRA, and manufacturers must not make claims suggesting otherwise.

For manufacturers located outside the UK, a UK Responsible Person (UKRP) must be appointed to act on their behalf and complete registration requirements.

Recent updates also include administrative changes within the DORS system, such as removal of certain fees related to updating organisation details and documentation, reflecting efforts to streamline regulatory processes.

Guidance: Clinical investigations for medical devices

Clinical investigations are often required to generate evidence supporting the safety and performance of medical devices, particularly for higher-risk or innovative products. Manufacturers must notify the MHRA of their intention to conduct a clinical investigation at least 60 days before the study begins.

These investigations are typically necessary to obtain regulatory markings such as UKCA or CE and to support conformity assessment processes.

However, notification may not be required in specific cases, such as when devices are manufactured and used in-house within a healthcare institution without the intention of placing them on the market.

Clinical investigations play a critical role in demonstrating device performance, identifying risks, and ensuring that devices meet regulatory standards before wider use.

References

For complete official guidance, refer to:

Register medical devices to place on the market

Clinical investigations for medical devices – MHRA Guidance