MHRA (Medicines and Healthcare products Regulatory Agency, UK)
The UK's regulatory authority for medicines, medical devices, and blood products. Post-Brexit, MHRA operates independently from the EU regulatory framework and requires UKCA marking for medical devices placed on the GB market.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency responsible for regulating medicines, medical devices, and blood components for transfusion. Following Brexit, the UK established its own regulatory framework separate from the EU, with MHRA as the competent authority.
Post-Brexit regulatory landscape
The UK now requires UKCA (UK Conformity Assessed) marking for medical devices placed on the Great Britain market, replacing CE marking. However, the UK has extended recognition of CE-marked devices through transitional provisions. The UK's regulatory route involves MHRA registration, conformity assessment by a UK Approved Body, and compliance with the UK Medical Devices Regulations 2002 (as amended). Northern Ireland follows EU MDR rules under the Windsor Framework.
MHRA in procurement
UK NHS tenders require devices to be registered with MHRA. Suppliers must navigate the dual regulatory landscape — CE marking for EU and Northern Ireland, UKCA marking for Great Britain. Procurement teams verify MHRA registration status and check for any safety alerts or field safety notices issued by MHRA.