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How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
How to use a cost effectiveness analysis to evaluate your digital health product.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to create a model of how your digital health product works and choose measures for your evaluation.
Compare different evaluation approaches and choose an appropriate method.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Guidance on choosing evaluation study types and methods.
How to use a cost utility analysis to evaluate your digital health product.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
How to use a before-and-after study to evaluate your digital health product.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Why it's important to evaluate digital health products that have been developed rapidly and how to choose evaluation methods in these circumstances.
How to use an interrupted time series to evaluate your digital health product.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
How we are building national capacity for product safety.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to use a cost benefit analysis to evaluate your digital health product.
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