What MHRA does
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
Contact MHRA
- info@mhra.gov.uk
- Phone
- 020 3080 6000
Official guidance from MHRA
Curated guidance documents to help you understand your obligations.
Medical devices - conformity assessment and the UKCA mark (opens in a new tab)
Detailed Guidance
MHRA — apply for a manufacturer or wholesaler of medicines licence (opens in a new tab)
Detailed Guidance
Regulating medical devices in the UK (MHRA guidance) (opens in a new tab)
Detailed Guidance
Software and AI as a medical device (MHRA guidance) (opens in a new tab)
Publication
Vigilance reporting requirements (opens in a new tab)
Publication
Current MHRA fees (opens in a new tab)
Publication
GMP guidance (opens in a new tab)
Detailed Guidance
Medical devices: how to comply with the legal requirements (opens in a new tab)
Detailed Guidance
View all 165 guidance documents (opens in a new tab)
Legal framework
Legislation that MHRA directly enforces.
Primary legislation
Secondary legislation
… and 3 more statutory instruments.
Related legislation
Legislation connected to MHRA’s remit but not directly enforced — establishing Acts, amendments, referenced legislation, and context.