UK medical device registration requires medical device companies to comply with the UK MDR and obtain UKCA Marking. Companies based outside the UK must also retain an in-country representative to liaise with the MHRA, UK's device regulator.
Pure Global simplifies the process with AI workflows that accelerate MHRA registration, along with local support and representation, all for a flat annual fee.
The UK medical devices market is valued at $17.67B (2023), growing at a 6.5% CAGR (2024–2032). The IVD market is worth $2.35B (2023), with 2.1% CAGR (2024–2030). Growth is driven by tech advancements, rising chronic diseases, and an aging population (19% 65+).
Medical devices sold in the UK regulated by The Medicines and Healthcare products Regulatory Agency (MHRA). Pure Global can assist with UK's medical device registration and act as your UK Responsible Person (UKRP), ensuring MHRA approval to sell in the British market.
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.
For market entry, manufacturers outside the UK must:
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.
UK Responsible Person (UKRP) service includes MHRA portal registration and more for an annual flat fee.
MHRA's fee structure is expected to change in April 2026 as part of the ongoing UKCA transition. The current registration fee is £261 (approximately USD 350) per application. Under the proposed new structure, an annual fee of £300 (approximately USD 402) per Level 2 GMDN code will apply. This fee is estimated and subject to confirmation. Approximately 60% of manufacturers are expected to incur a single annual charge, depending on how their devices are grouped at the Level 2 GMDN level.
All fees listed are government fees only and do not include consulting services, dossier preparation, conformity assessment activities, or regulatory representation. Fees and implementation details may change as the UKCA framework continues to evolve.
Check our Fee Calculator for up-to-date government fees in 14 markets.
Medical devices in the UK are classified according to their risk level, as outlined by the UK medical device classification system. This classification guides the regulatory requirements and the process for achieving UKCA marking and MHRA registration. Higher-risk devices typically require more rigorous scrutiny and documentation.
Foreign manufacturers must: Appoint an MHRA UK Responsible Person (UKRP) to act on their behalf. Ensure compliance with UK Medical Device Regulations (UK MDR) requirements and achieve UKCA marking for their devices. Register their devices with the MHRA through the MHRA UK Responsible Person, adhering to specific deadlines for transitioning from CE marking to UKCA marking.
Appointing a UK Responsible Person (UKRP) is crucial for foreign manufacturers because the UKRP acts on behalf of the manufacturer in dealings with the MHRA. The UKRP ensures compliance with UK MHRA medical device regulation, facilitates communication, and handles the registration and market access process, enabling the manufacturer to sell their medical devices in the UK.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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