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Data, Freedom of Information releases and corporate reports
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Information and guidance on a range of medical devices for users and patients.
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.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Order a certificate of free sale to export medical devices outside the UK.
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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information for British people on medical support in Thailand including mental health, lists of hospitals and care homes and how the British embassy can help.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Information about the EU Regulations and their implementation in Northern Ireland
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to use a case-control study to evaluate your digital health product.
Guidance on sources of electromagnetic interference and mitigating the risks.
Advice on writing clear notices and maximising replies to your FSNs.
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