MHRA (UK)
Medicines and Healthcare products Regulatory Agency
The UK's regulator for medicines, medical devices and blood components — operating post-Brexit under UK MDR 2002 and the Human Medicines Regulations 2012.
Since the end of the Brexit transition, MHRA regulates Great Britain (England, Scotland, Wales) independently of the EMA, while Northern Ireland continues under EU rules (the Windsor Framework, replacing the NI Protocol). MHRA inspections follow the PIC/S GMP Guide; the UK Conformity Assessed (UKCA) mark gradually replaces CE for GB-marketed devices, with timelines repeatedly extended (current Statutory Instrument: indefinite recognition of CE marking for most devices).
MHRA's 2022 Data Integrity guidance is the most-cited modern reference outside FDA's 2018 guidance.
- UK MDR 2002 (as amended)
- Human Medicines Regulations 2012
- MHRA Data Integrity Guidance (2022)
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