UK Medical Device Registration Process: A 6-Step Guide to MHRA Compliance

UK Medical Device Registration: The 6-Step Process for MHRA Compliance

To introduce a medical device to the UK market, manufacturers must comply with the Medicines and Healthcare Products Regulatory Agency (MHRA), which ensures devices meet high standards of safety and efficacy. This guide summarizes the required registration process.

Step 1: Determine Device Classification

Medical devices are classified into four categories based on risk level:

• Class I (Low Risk)
• Class IIa and IIb (Medium Risk)
• Class III (High Risk) The classification determines the regulatory route, with higher-risk devices (like Class III) requiring more rigorous testing and documentation.

Step 2: Conformity Assessment

This step ensures the device complies with relevant UK regulations.

• Class I devices may use Self-certification.
• Class II and III devices require Third-party certification by a UK Approved Body (formerly a Notified Body), which reviews the technical documentation.

Step 3: Technical Documentation and Marking

Manufacturers must compile comprehensive technical documentation, including design, manufacturing details, clinical data, risk assessment, and labeling information, to prove conformity with UK regulations.

• UKCA Marking: Although a device may be CE-marked, it will need to undergo a UKCA marking process post-Brexit to be fully compliant in the UK.

Step 4: Appointing a UK Responsible Person (UKRP)

For manufacturers based outside the UK, the appointment of a UK Responsible Person (UKRP) is mandatory. The UKRP acts as the point of contact for the MHRA and is responsible for:

• Submitting registration information to the MHRA.
• Ensuring ongoing device compliance.
• Communicating with the MHRA on adverse events or complaints.

Step 5: Device Registration with MHRA

The final submission is done via the Device Online Registration System (DORS). This step involves:

• Creating a profile for the device.
• Providing required documentation and paying registration fees.

Step 6: Post-Market Surveillance and Vigilance

Registration is not the end of the process. Manufacturers are required to maintain post-market surveillance (PMS), continuously monitoring and reporting any safety issues or device failures (incidents, recalls, or corrective actions) to the MHRA. Failure to adhere to these vigilance requirements can result in penalties.

Costs: Registration fees are annual and vary based on device classification, with Class II and III devices incurring higher costs due to the required third-party assessments.