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Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

Strategic recommendations on the topic of market access pathways for medical devices and IVD tests

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White Paper: Market Access Landscape for Health Apps in Europe

Get insights from MTRC White Papers to explore practical strategies for navigating digital health reimbursement in Europe and discover how health app developers build effective strategies for market entry and scale 

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Updated Digital Technology Assessment Criteria (DTAC) Guidance and Form in England

In late February 2026, NHS England revised its Digital Technology Assessment Criteria (DTAC), a framework used by commissioners and providers to assess digital health technologies before adoption across the health and social care system. The update follows a comprehensive review conducted in 2024, incorporating feedback from industry and NHS organisations to improve usability and efficiency.

The key changes include the following:

  • A new DTAC form with a 25% reduction in questions, de-duplicated with processes such as the data security and protection toolkit and the pre-acquisition questionnaire;
  • Clearer guidance explaining DTAC’s purpose, scope, and how to complete assessments;
  • Confirmed scope alignment with NICE, focusing DTAC on software-based digital health technologies.

DTAC continues to evaluate technologies across five core areas: clinical safety, data protection, technical security, interoperability, and usability and accessibility. These criteria ensure that digital tools used within the NHS meet consistent national standards for safety, effectiveness, and integration.

Care commissioners and providers are responsible for ensuring that any digital health technology (DHT) products they use or recommend meet all national standards and requirements. When assessing products, they should rely on a completed DTAC form provided by the manufacturer. DHT manufacturers must demonstrate that their products meet DTAC’s minimum standards by maintaining an up-to-date DTAC form, along with the required supporting documentation for each product version. The DTAC form should be made available upon request.

Examples of DHT products to which DTAC applies include:

  • Medical devices classed as software or AI as a medical device (for example, AI-driven clinical decision support tools, cognitive behavioural therapy web or mobile apps);
  • Software, apps, or wearables designed to help people manage their own health and wellbeing (for example, health tracking, remote monitoring);
  • Software designed for use in or to help the health and care system run more efficiently or help staff manage their time, staffing, or resources (for example, population health management tools, software for visualising and analysing imaging output).

The updated DTAC form replaces the previous version, with NHS England mandating a full transition by April 6, 2026, after which the older form should no longer be used.

The full details can be found here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.