MHRA - UK Medicines and Healthcare Products Regulatory Agency

The Medicines and Healthcare Products Regulatory Agency (MHRA) is government agency that regulates pharmaceuticals , blood establishments, advanced therapy medical products and medical devices in the United Kingdom. Working under the Department of Health, the MHRA also incorporates the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD).

The agency formed following the merger in 2003 of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA), then in 2013 with the National Institute for Biological Standards and Control (NIBSC). Its activities include overseeing UK notified bodies, regulating clinical trials, monitoring compliance for medicines and medical devices, as well as offering technical and regulatory advice for these products.

Major Regulations

Some of the most important European regulations for medical devices in the EU are:

A full list of EU regulations can be found here.

Contact details:

Medical Device Associations in the United Kingdom: