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Data, Freedom of Information releases and corporate reports
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.
Information about the EU Regulations and their implementation in Northern Ireland
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information and guidance on a range of medical devices for users and patients.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Mental health support and advice facilities for service personnel, reservists, veterans and service families.
Submission dates and how the submissions using the EC decision reliance procedure work.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
The Advisory Group on Military and Emergency Response Medicine (AGMERM) provides specialist advice to the Ministry of Defence on the medical aspects of defence against chemical, biological and radiological threats. AGMERM works with the Ministry of Defence .
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Marburg virus is a Filovirus which, along with Ebola virus, can cause a severe and often fatal viral haemorrhagic fever (VHF).
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
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