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Navigating the UK's Medical Device Regulatory Landscape

With a population nearing 68 million and ranking as the third-largest medical device market in Europe, the United Kingdom presents significant opportunities for foreign manufacturers. The National Health Service (NHS), as the primary healthcare provider, is a major procurer of medical devices, highlighting the demand for innovative healthcare solutions in the UK market.

Device Classification and Regulatory Pathways

Understanding the UKCA Marking and MHRA Registration

Regulatory Authority

Following Brexit, the UK introduced the UK Conformity Assessed (UKCA) marking, transitioning from the European CE marking to establish its own regulatory framework under the UK Medical Devices Regulations 2002 (UK MDR). The Medicines and Healthcare products Regulatory Agency (MHRA) oversees medical device regulation, ensuring products meet the necessary safety and performance standards.

Classification

Medical devices in the UK are classified according to risk, with the classification guiding the regulatory requirements and process for achieving UKCA marking and MHRA registration.

Key Requirements

For market entry, manufacturers outside the UK must:

  • Appoint a UK Responsible Person (UKRP) to act on their behalf.
  • Ensure compliance with UK MDR requirements and achieve UKCA marking for their devices.
  • Register their devices with the MHRA through the UKRP, adhering to the specific deadlines for CE and UKCA marking transition.
How We Can Help

Tailored Support for Market Entry

Our services are designed to streamline your regulatory process in the UK:

  • Assistance with product classification and identification of the UK regulatory pathway.

  • Compilation of technical documentation required for UKCA marking and MHRA registration.

  • Acting as your UK Responsible Person (UKRP), managing the MHRA registration process and ensuring compliance with post-market requirements.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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