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Deviceology - UK Market Access

Deviceology is primed to assist clients in successfully entering the UK's burgeoning Medical Devices sector. Our team of experts can help you meet the stringent  MHRA regulatory requirements. Our regulatory specialists can build your Product Technical Files, identify an appropriate Notified Body, represent you at the certification audits  and help you gain your UK CA marking.  

Once certified, we can act as your UK Responsible Person (UKRP), support your post-market surveillance and viligiance activity, conduct your internal audits, help during annual surveillance visits and keep your product technical files up to date . 

A distinct advantages of the UK market is the National Health Service (NHS), often seen as a one provider, one payer model. This simplifies procurement and allows for better market penetration.  We are experts in the complexities of operating within the NHS  and the pre-requisites for digital products. We can prepare your NHS Digital Technology Assessment Criteria and Data Security Toolkit submissions, help you integration with NHS APIs, and help you meet ISO27001 and ISO9001 compliance requirements.

If you’re new to the UK market or want help with ongoing regulatory obligations, please get in touch
 

Market Data

Medical Devices Market Valuation

Market Segmentation

Cardiology Devices: Largest sub-market,  projected  US$2.48 billion in 2023.

Other Segments:   Diagnostic Imaging, In Vitro Diagnostics (IVD), Orthopaedics, Ophthalmic Devices

Healthcare Expenditure

Approximately £282 billion were spent on healthcare in the UK in 2022. This includes both public and private healthcare spending.

Opportunities

The UK has an aging population, creating a growing demand for medical devices that cater to age-related health issues including Monitoring devices, Respiratory Aids, Cardiac Devices and Orthopedic Implants.

2023: Projected $17.52 billion

2028: Projected $21.13 billion

Market Dynamics

Technological Advancements: Rapid innovation is driving market growth, especially in areas like telehealth and minimally invasive procedures.

 

Regulatory Changes: Post-Brexit regulations, including the UKCA marking, have created a distinct landscape for medical device approvals.

Aging Population: An increasing number of elderly individuals are creating demand for devices catering to age-related health issues.

 

NHS Framework: The National Health Service (NHS) is a significant buyer, and its procurement strategies impact market dynamics.

Contact us to discuss your access requirements for the United Kingdom's Medical Devices market

Deviceology - The Market Access People

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