UK Med Dev Guidance: Registration and Clinical Investigation Pathways

Sharan Murugan
Oct 26
3 min read

The UK’s post-Brexit regulatory landscape for medical devices continues to evolve, placing renewed emphasis on safety, performance, and transparency. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clear guidance on both registering medical devices for market access and conducting clinical investigations, ensuring compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Windsor Framework. This combined overview summarizes the latest guidance from:

1. Register Medical Devices to Place on the Market

This guidance explains the requirements for registering medical devices before they can be placed on the UK market. It applies to manufacturers, authorised representatives, and importers depending on the device’s intended market (Great Britain, Northern Ireland, or both).

Key Sections and Insights

a. Registration Requirements

All medical devices, including in vitro diagnostic (IVD) devices and custom-made devices, must be registered with the MHRA before being marketed in the UK.

b. Device Classifications

The device must be classified according to its intended purpose and risk level, using the UK Medical Devices Regulations 2002 (as amended).

Class I, IIa, IIb, and III correspond to increasing levels of risk.
Manufacturers must determine classification accurately since it dictates conformity assessment routes and documentation.

c. Economic Operators and Responsibilities

Manufacturer: Ensures conformity and registration accuracy.
Authorised Representative (UK Responsible Person): Acts on behalf of non-UK manufacturers.
Importer: Ensures devices are compliant before sale.

d. Registration Portal and Process

Manufacturers and representatives must use the MHRA Device Online Registration System (DORS), providing information such as device name, intended use, classification, and conformity mark.

e. Great Britain vs Northern Ireland Requirements

Devices for Great Britain require UKCA marking.
UKCA Mark: The UK Conformity Assessed marking indicates compliance with UK regulatory requirements post-Brexit, replacing the EU’s CE mark in Great Britain.
Devices for Northern Ireland can continue to use CE marking under EU alignment rules.

Implication:

Proper registration and compliance with marking rules are mandatory before commercial distribution. Non-compliance can lead to enforcement actions or product withdrawal from the market.

Read full MHRA guidance: Register medical devices to place on the market

2. Clinical Investigations for Medical Devices

This guidance outlines the regulatory process for notifying the MHRA about a clinical investigation intended to evaluate the performance or safety of a medical device in human participants.

Key Sections and Insights

a. Purpose of Clinical Investigations

Clinical investigations are required to gather evidence of safety, performance, and clinical benefits for new or significantly modified devices before they can be marketed.

b. Submission and Notification Process

Manufacturers must notify the MHRA before starting an investigation. The submission includes:

Device technical documentation
Study protocol
Investigator’s brochure
Ethics approval details (if applicable)

The MHRA reviews the submission for completeness and scientific validity before authorisation.

c. Assessment and Timelines

The MHRA assessment ensures participant safety and scientific integrity. Sponsors cannot commence investigations until MHRA provides written confirmation.

d. Amendments and Early Termination

Any substantial amendments to the investigation must be resubmitted for review. Sponsors must also notify the MHRA in case of early termination or temporary halts, providing reasons and safety data.

e. Northern Ireland and Combined Reviews

Separate provisions apply for studies conducted in Northern Ireland, which remain aligned with EU device legislation.
A combined review process exists for investigations that also involve a clinical trial of a medicinal product (CTIMP), streamlining submissions to MHRA and ethics committees.

Implication:

Manufacturers must plan and document every step of the clinical investigation carefully. Proper MHRA notification ensures compliance and smooth progression to market authorisation.

Read full MHRA guidance: Clinical investigations for medical devices

Together, these MHRA guidances provide a structured, transparent framework for medical device innovation in the UK.