How to register a medical device in the UK

This video gives foreign medical device manufacturers a clear, step-by-step guide to entering the UK’s $17.67 billion medical device market—the third largest in Europe and forecast to grow 6.5% annually through 2032. The in vitro diagnostics (IVD) segment alone is worth $2.35 billion and is projected to grow at 2.1% CAGR. Demand is fueled by the UK’s single-payer National Health Service (NHS), which actively sources innovative technologies to improve patient outcomes, alongside rising chronic disease rates, an aging population, and rapid technological advancement.

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Topics covered in this video include:

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• UK medical device market size, growth drivers, and NHS procurement trends
• The MHRA’s role in regulating medical devices and IVDs
• Risk-based classification and its impact on documentation requirements
• UKCA marking standards and CE-to-UKCA transition timelines
• The essential role of the UK Responsible Person (UKRP) in securing market access
• Key steps for foreign manufacturers to register with the MHRA
• How Pure Global streamlines compliance and accelerates multi-market expansion

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The UK’s regulatory framework is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). All devices must achieve UKCA (UK Conformity Assessed) marking and be registered with the MHRA before they can be placed on the market. Device classification is risk-based, with higher-risk products subject to more stringent requirements and detailed technical documentation. Manufacturers must also pay close attention to the ongoing transition deadlines from CE marking to UKCA marking to ensure uninterrupted market access.

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For manufacturers without a UK presence, appointing a UK Responsible Person (UKRP) is a mandatory first step. The UKRP acts as your official representative, liaising directly with the MHRA, maintaining technical documentation, overseeing registration, and ensuring continuous compliance with UK Medical Device Regulations (UK MDR). Without a UKRP, foreign manufacturers cannot legally market or distribute devices in Britain.

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Need help with UK medical device registration?‍

Pure Global helps manufacturers enter and thrive in the UK through one streamlined process that can scale to other markets worldwide. We handle product classification, prepare UKCA technical documentation, act as your UKRP, manage MHRA registration, and guide ongoing compliance. With our expertise, you can minimize regulatory risk, shorten approval timelines, and focus on innovation. Learn more about MHRA UK Medical Device Registration & Approval.

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