Blog & Insights

News, guidance, and insights for healthcare procurement.

Expert perspectives on medical device regulations, NHS procurement frameworks, equipment selection, and the future of healthcare supply chains.

Regulatory Guidance

Understanding NICE Guidelines for Medical Device Procurement

Medical device technology and regulatory documents

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care across the United Kingdom. Its Medical Technologies Evaluation Programme (MTEP) evaluates medical devices and diagnostics to determine whether they offer clinical and economic benefits to the NHS.

How NICE evaluates medical technologies

The MTEP process assesses medical technologies against two core criteria: clinical effectiveness and cost impact. Technologies that demonstrate both improved patient outcomes and cost savings to the NHS may receive positive NICE guidance, supporting their adoption across the health service.

NICE also publishes medtech innovation briefings for technologies that show promise but lack the full evidence base required for full guidance. These briefings help NHS procurement teams identify emerging innovations worth monitoring.

What this means for procurement

Healthcare procurement teams should be aware of NICE guidance relevant to their equipment categories. Products supported by positive NICE guidance may have a stronger case for adoption, and many NHS framework agreements align their catalogues with NICE recommendations.

NICE guidance is publicly available at nice.org.uk. Procurement professionals should regularly review relevant guidance in their clinical areas to ensure equipment choices reflect the latest evidence.

How we support our customers

Clear Medical Supply helps healthcare providers identify products in our catalogue that are supported by NICE guidance. If you'd like assistance aligning your equipment portfolio with current NICE recommendations, contact us at sales@clearmedicalsupply.com.


Regulatory Guidance

Medical Device Software: Understanding MHRA Regulation

Healthcare IT and medical software

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's competent authority for medical devices, including software as a medical device (SaMD). The MHRA regulates medical devices under the UK Medical Devices Regulations 2002 and publishes guidance to support compliance.

What is Software as a Medical Device?

SaMD is software intended to be used for medical purposes without being part of a hardware medical device. Examples include diagnostic imaging software, clinical decision support tools, patient monitoring applications, and digital therapeutics. The MHRA classifies SaMD based on the level of risk it poses to patients and users.

Regulatory requirements

Medical device software placed on the UK market must comply with the UK Medical Devices Regulations 2002. Depending on classification, this may require UKCA or CE marking. Manufacturers must maintain technical documentation demonstrating compliance with relevant safety and performance requirements.

The MHRA provides guidance on its website regarding software classification, conformity assessment routes, and post-market surveillance obligations. This includes requirements around cybersecurity, clinical evidence, and risk management.

What healthcare providers should know

When procuring software that may qualify as a medical device, NHS and private healthcare organisations should verify that suppliers hold the appropriate regulatory approvals. This is particularly important for software used in clinical decision-making, diagnosis, or patient monitoring.

For the latest MHRA guidance on medical device software, visit gov.uk/mhra. If you have questions about the regulatory status of equipment in our catalogue, contact us at sales@clearmedicalsupply.com.


Sustainability

Sustainability in Medical Equipment and the NHS Net Zero Roadmap

Modern sustainable hospital facility

The NHS is committed to achieving net zero carbon emissions. The NHS Net Zero Supplier Roadmap sets out the requirement for all suppliers to demonstrate progress on carbon reduction, with all suppliers expected to have a carbon reduction plan in place.

The NHS Net Zero Supplier Roadmap

Published by NHS England, the roadmap applies to all suppliers of goods and services to the NHS. It aligns with the UK government's commitment to net zero by 2050 and the NHS's own target of net zero by 2045 for the emissions it controls directly. Key requirements for suppliers include publishing carbon reduction plans and reporting on greenhouse gas emissions.

What this means for medical equipment

The manufacture, distribution, use, and disposal of medical equipment all contribute to the healthcare carbon footprint. Procurement decisions play a significant role in the NHS's ability to meet its environmental targets. Equipment with longer operational lifespans, lower energy consumption, and recyclable packaging can all contribute to carbon reduction.

NHS trusts are required to produce Green Plans detailing how they will reduce their environmental impact. These plans increasingly reference sustainable procurement as a key lever for carbon reduction.

How Clear Medical Supply supports sustainability

We work with manufacturer partners who hold ISO 14001 environmental management certification where possible. Our logistics planning aims to consolidate deliveries and optimise routes. We also support equipment servicing and calibration to extend operational lifespans, reducing waste from premature replacement.

If your organisation would like to discuss sustainability in your medical equipment supply chain, contact us at sales@clearmedicalsupply.com.

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