Browse Guidance for Medical Devices resources...

A guide to good practice for digital and data-driven health technologies

Guidance for Digital Technology

The future of healthcare: our vision for digital, data and technology in health and care

Policy paper giving direction for digital health care

The digital technology assessment criteria for health and social care

Application form for DTAC

Regulatory guidance for medical devices

Guidance on legal requirements for medical devices

Medical device standalone software including apps

Guidance for software applying for UKCA approval

Introduction to ESF for digital health technologies

Introduction to evidence standards framework for digital health technologies

Understanding regulations of AI and digital technology in health and social care

Learn what regulations to follow and how to evaluate effectiveness, whether you're a 'developer' of AI and digital technology or an 'adopter' who will buy or use them in health and social care.

Implementation of medical devices future regime

The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

Statement of intent: International recognition of medical devices

The MHRA released a statement on their plans to recognise medical device approval from international regulators. It states that AIaMD will have a review of training and test data.