UK Medical Device Registration (MHRA): Compliance, UKCA Marking, and the UK Responsible Person

UK Medical Device Registration and the UKCA Regime

The market for medical devices in the United Kingdom (specifically Great Britain—England, Wales, and Scotland) is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The core regulatory framework is the UK Medical Devices Regulations (UK MDR).

1. Regulatory Authority and Registration

• Regulator: The MHRA is the primary authority responsible for regulating medical devices in the UK.
• Mandatory Registration: All medical devices, including In Vitro Diagnostic (IVD) devices, must be registered with the MHRA before they can be placed on the Great Britain market.
• Classification: Devices are classified according to their risk level, which determines the necessary regulatory requirements for achieving the UKCA marking and MHRA registration. Higher-risk devices require more rigorous scrutiny.

2. The UK Responsible Person (UKRP)

For manufacturers established outside the UK, market entry requires the mandatory appointment of a UK Responsible Person (UKRP).

• Role of the UKRP: The UKRP acts as the manufacturer’s representative to the MHRA, ensuring ongoing compliance with the UK MDR.
• Responsibilities: The UKRP is responsible for key regulatory tasks, including:
  • Registering the manufacturer's devices with the MHRA.
  • Ensuring the manufacturer has complied with the UK MDR and affixed the appropriate conformity marking (UKCA).
  • Managing communication with the MHRA, including post-market surveillance and vigilance requirements.

3. Conformity and Marking (UKCA)

The UK Conformity Assessed (UKCA) marking is the mandatory conformity mark for medical devices in Great Britain.

• Requirement: Manufacturers must ensure their devices comply with the UK MDR requirements and affix the UKCA mark.
• Transition from CE: Manufacturers must adhere to specific deadlines for transitioning from the EU's CE marking to the UKCA marking. However, the government has introduced transitional arrangements allowing CE-marked devices to continue being placed on the GB market for defined periods (with deadlines extending up to June 30, 2030, depending on device class and compliance).