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How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
Latest news and press releases, information on meetings and events, public consultations and related patient safety information.
Information and guidance on a range of medical devices for users and patients.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How we engage and involve patients and the public in our regulatory decision-making.
Information for patients, healthcare professionals and developers of new medicines
Work is ongoing to address the comments and feedback from respondents to the consultation. Publication of our report on the consultation has been delayed in light of the Agency’s response during the ongoing coronavirus situation.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use an ethnographic study to evaluate your digital health product.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Information for NHS patients and service users.
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